Conference report

The 53rd AESGP Annual Meeting - the annual gathering of the self-care sector in Europe was held in Vien-
na, Austria from 30 May 1 June 2017. Entitled Self-Care in a Changing World, the conference looked at
this overarching theme from three angles: marketplace, regulation and policy covering non-prescription
medicines including herbal medicinal products food supplements and self-care medical devices.
Around 350 representatives from the industry and many stakeholder organisations attended the meeting.

The first day of the conference heard success stories, delved into how the industry is doing with the recent
unprecedented level of consolidation in the pharmaceutical sector including the consumer health industry
and gave an overview of the changing environment for health care professionals.

Opening Evening
Birgit Schuhbauer, President of the Association of the
European Self-Medication Industry (AESGP), and Global
Vice President of Johnson & Johnsons OTC Franchise,
welcomed delegates to the 53rd AESGP Annual Meeting
in Vienna, Austria, in a speech at the opening evening in
the Vienna City Hall.
She applauded the progress made in self-care in Europe
from both on the regulatory side and political side
since the launch of the associations Agenda 2020 last
year.
I feel particularly encouraged by the recommendations
on the future of self-care submitted to a European Un-
ion (EU) project by the European Umbrella Organisation
of Medical Doctors, the CPME, she stated.

Details of the CPMEs recommendations on the future of

self-care would be presented during the conference, she
explained, by the organisations President Jacques de
Haller.

Globalisation, mergers and acquisitions, the role of

health professionals, social media and big data, would
also be high on the conference agenda, she pointed
out, along with new legal and regulatory developments
for non-prescription medicines, food supplements and
self-care medical devices.

Birgit Schuhbauer

1
It was important to keep in mind, she said, that the
meeting was taking place against a background of un-
precedented debates on the future of Europe with
new hopes after the elections of this year but also dis-
appointing votes in 2016.
Let me clearly say that we would like to see a strong
Europe, she insisted. Single Market is not a very pop-
ular phrase these days, but is still high on our agenda.
Pointing out that it was only eight years since the
AESGP had held its Annual Meeting in Vienna,
Schuhbauer said that the choice recognised the 50th
birthday of the countrys local association IGEPHA, and
the organisations efforts to improve self-care in the
country.
Also speaking at the Vienna City Hall opening evening,
Dr Gerhard Ltsch, President of IGEPHA, the Austrian
Self-Care Association, said the Austrian healthcare sys-
tem was a good one, but healthcare systems cost mon-
ey. IGEPHA could offer viable solutions, he maintained,
by providing methods to help improve health literacy as
well as inexpensive but effective ways to treat oneself.
Gerhard Ltsch
IGEPHA is also keen to work with regulators, he added,
to widen access to medicines.
Former President of the Austrian Self-Care Association,
Alfred Grn, was thanked for his 25 years of service
within the AESGP Economic Affairs and Public Relations
Committee (ECOCOM). Schuhbauer remarked that for
most us, you were always there, noting the significant
impact of Grns work for a quarter of a century.
Taking over in 2010 as Chair of the ECOCOM from Brian
McNamara now Chief Executive Officer at GSK Con-
sumer Healthcare and Chair of the World Self-
Medication Industry (WSMI), Grns contribution
became even more evident. Alfred Grns role was
however not limited to the AESGP as he also served as
President of the Austrian Self-Care Association (IGEPHA)
from 2007 to 2014. In this function, he also represented
IGEPHA on the AESGP Board, a function which he had
kept until now.
Thank you on behalf of all of us for your outstanding
work, the great achievements, but above all your excel-
lent leadership and personal friendship, Schuhbauer
said, joined by the applause of the 300 guests attending
this evening at the Vienna City Hall.
Alfred Grn
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Global Changes and their Implications on Consumer Healthcare
In her opening remarks, the session moderator Cathy
Smith introduced the theme of the conference. Self-
care and the self-care industry are changing massively,
and over the coming days, speakers will provide an
overview of general trends, changes in the digital space,
where the scope is for innovation, and update on new
regulatory developments. The focus of the first session
was global developments and its implications for Eu-
rope as a whole and the provision of healthcare.
Cathy Smith
Global economy and the impact on con-
sumer spending
Nenad Pacek, President of Global Success Advisors,
began by acknowledging the difficulties with budgeting
and predicting where markets are going. He explained
how declines in sales growth, for example, in Saudi Ara-
bia, are often difficult to predict. The reason, he ex-
plained, resides in the fact that the financial industry has
hijacked deregulation; there is massive speculation in
commodity and currency markets but also in buying
government bonds of Ghana/ Brazil or treasury bills of
Indonesia. No one is attempting to regulate those ac-
tivities whatsoever, he went on to explain. Less than
3% of all oil trading in the world is done by countries
and people who need oil. This raises budgeting con-
cerns for markets and territories and often the changing
external environment is to blame.
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Conference report
He recognised that this has gotten worse over the last
ten years, as we are living in the aftermath of the 2009
financial crisis. The year 2009 saw the biggest global
crisis in 80 years, and its consequences can still be felt
today.
Nenad Pacek
In the US, half of the money from quantitative easing
programs ended up in financial institutions, and some
were used to buy government bonds in South Africa.
Emerging markets were doing well thanks to cash from
the US leading to inflation of assets. When there was an
outflow of capital in 2015 and 2016, all commodity mar-
kets went down Latin America, the Middle East, Aus-
tralia, Indonesia and Russia. The quantitative easing pro-
grammes created a large amount of volatility in the US
since 2010.
We are now recovering from this, Nenad explained.
The US economy following this huge money printing
will continue to grow, consumer spending is recovering,
unemployment rates are low, and the federal reserve
will have increase interest rates (which he noted, are
signs of a recovering economy).
The Eurozone is having its best year since 2007 and
2008, he commented. The EU has its own quantitative
easing program since 2015, which made the euro
cheaper, making European exports more competitive.
Exports are doing well, he remarked, and this is lead-
ing to improved consumer spending. Lending is also would no longer work, especially in volatile emerging
improving banks now have freshly printed cash. He markets.
explained that most countries except Greece have easy
access to finance, so governments can spend more Simplify to improve switch
freely instead of having austerity programmes in place.
Karl Broich, Director General, Federal Institute for
This strong performance in the Eurozone is helped by
Drugs and Medical Devices (BfArM), Germany gave an
the weak global commodity prices, which means that
overview of global developments from a European and
there is no inflation and interest rates will remain low.
German authority perspective. He explained that in Eu-
When the quantitative easing programme ends in
rope there is a centralised marketing authorisation
2017, we will start to see the first increase in interest
route for non-prescription medicines leading to a har-
rates in 2018, he warned, which may affect the con-
monised marketing authorisation and the decentralised
sumer. For the next 12 months, however, consumer
procedure. However, there are different approaches
spending should remain robust, he reassured.
used across Europe. Therefore, the Co-ordination Group
for the Mutual Recognition and Decentralised Proce-
Labour shortages in central Europe are driving wages
dures-Human (CMDh) established a European platform
up, and driving retail sales. In the East, Russia is barely
for non-prescription medicines to get more harmonisa-
growing, but volume growth is coming back in local
tion around non-prescription status.
currency. In Russia, 2/3 of its exports are hydrocarbon
related, and the country relies a lot on commodities.

A growth of 6% is the forecast for emerging countries in

Asia. In China, local players are gaining an upper hand
over multinationals. Japan is trying to escape deflation
with falling prices. The Middle-East is struggling as oil
prices are low, even in markets not driven by oil such as
Egypt. Pakistan is doing well, with a double-digit market
growth. Brazil is experiencing the worst recession in 80
years.

Competition will get worse as well. From a competi-

tion standpoint, he described four threats: large multi-
nationals which are better and better organised around
the world, the threat from emerging markets, the threat
from small, medium-sized companies and the rise of
family business. The external environment will be vola-
tile from a macroeconomic side, he added.

Innovate more, he urged, but make these innovations

deeply relevant to the local market. Ensure your product Karl Broich
and marketing mix is right, do frequent consumer re-
The Non-Prescription Medicinal Products Task Force, he
search as the consumer is changing in this volatile world
explained, aims to explore new ways to improve conver-
and dont get lazy with your marketing messages.
gence on evaluation and facilitate access to safe and
effective OTC products for EU citizens. Efforts to im-
The traditional distributor model is dying, he said.
prove the functioning of the marketing authorisation
You must be present in the market. Look at your oper-
system for non-prescription medicines along the lines of
ations and ask if you have enough local people in place
the AESGP Self-Care Agenda 2020 will be a further key
to get the insights into the market you need, he ad-
element. The Task Force will provide recommendations
vised. The quicker you localise the better. He ex-
to the CMDh and the Heads of Medicines Agencies
plained that centralising operations and leaving prod-
(HMA) on matters relating to OTC products, explore
ucts in the hands of local distributors was a model that
best practices both at the level of national competent
authorities (NCAs) and industry, revise the Best Practice

4

Guide on the Decentralised Procedure (DCP) for non-
prescription medicines and engage with relevant trade
associations to discuss OTC status at European level.
The Task Force is constituted for the period of time
needed to complete tasks committed by the CMDh. It is
composed of members of the CMDh or experts from
NCAs and BfArM is actively involved with German
CMDh member participated from the beginning and
Martin Huber as the recently elected chair of the Task
Force. Non-European Union countries may also partici-
pate if they are prepared to sign confidentiality agree-
ments.
Another committee at European level is the Committee
of Experts on the Classification of Medicines as regards
their supply set up by the Committee of Ministers under
Article 17 of the Statute of the Council of Europe. Its
tasks include reviews on classification practices, underly-
ing rationale, develop and promote good classification
practices, monitor trends and the impact of the classifi-
cation of medicines on medicines safety and accessibil-
ity to the patient and develop further and coordinate
the updates of a web published database presenting
the classification status of medicines in the Member
States (MELCLASS database).
In Germany, he explained, a substance-based classifica-
tion system is laid out in the German Medicines Act
(Arzneimittelgesetz), and decisions are taken by the
Ministry of Health in a legal act. Except in cases where a
substance is not generally known where it is automati-
cally subject to medical prescription prior consultation
of an Expert Advisory Committee is warranted. The
committee is composed of stakeholders and experts in
the field (academia, clinical practice etc.) BfArM acts as
the secretary/contact point for this committee and hosts
the meeting.
The National Switch Committee meets twice a year. A
company or any other party can submit an application
for a change of the legal classification, and the applica-
tion is then sent to BfArM for validation and scientific
assessment, which will then go to the Expert Advisory
Committee.
He explained that more and more, BfArM are consider-
ing the international experience with the usage of a
medicine in an OTC setting outside Germany and out-
side the European Union. The application together with
the BfArM assessment is then being considered by the
Expert Advisory Committee. The committee can consult
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further external experts on a case-by-case basis for spe-
cific topics. The committee then issues a recommenda-
tion as to whether the legal status should be changed.
The recommendation is addressed to the Ministry of
Health which takes the final decision.
He stressed that a standardised approach to future sub-
missions to change legal status should be put in place.
Although it is always a case-by-case assessment, the
Brass et al. benefit-risk model and methodology pro-
vides an established standard for evaluating and decid-
ing on switch applications in Europe.
He also urged industry to make use of the improved
level of OTC expertise at national agencies and engage
with these agencies prior to filing, noting that in line
with the AESGP 2020 agenda, BfArM had the ability to
offer scientific advice and preparatory meetings on
switch proposals before an application was made.
We should be more visible as regulators, he remarked.
On the issue of transparency regarding the criterion
used to evaluate products and changes in classification
status as described in the AESGP 2020 agenda, he ex-
plained that detailed guidance on switches is available
on the BfArM website. Procedural clarification meetings
are also provided. He believes that the same standards
for safety should apply regardless of prescription status,
without being too risk-focused.
He concluded with BfArMs future priorities, which in-
clude further interaction and exchange of views with
stakeholders within Europe and outside Europe,
strengthening expertise in the field of OTC medicines,
optimising Scientific Advice regarding OTC switches
(both at EU and national level) and the use of other data
sources (e.g. digital media) in the decision-making pro-
cess.
Trust driving the Self-Care Agenda forward
Brian McNamara, Chief Executive Officer, GSK Consum-
er Healthcare and Chair, World Self-Medication Industry
(WSMI), gave his perspective on how both GSK and the
industry are serving consumers and driving the self-care
agenda forward.
OTC contributes over 100 billion dollars per year in the
US - $7 is saved for every $1 of OTC sales. In Spain,
835 million euros could be saved each year by switch-
ing 5% of prescription medicines to OTCs and in the UK,
2 billion could be saved each year in reduced doctors
visits for minor ailments were self-treated with OTCs,
he quoted. Reacting to the changing environment,
there is a huge opportunity to increase access and drive
the safe use of consumer healthcare products, he ex-
plained.
Brian McNamara
Against a backdrop of Brexit and uncertain elections
across the continent - France, Netherlands, Germany,
Austria, the US/Trump administration and drama in
North Korea businesses need to navigate through the
challenges of emerging markets slowdown and high
volatile, tightening government and household budgets,
drug pricing focus, demanding capital markets and a
trust deficit.
At the same time, there is clear interest and opportunity
in self-care. Google searches for self-care have reached
a five-year high immediately after US election last No-
vember. As we deal with the challenging environment,
its important to put consumers at centre of all we do,
he explained. By placing the consumer at the centre of
what we do, he insisted, we can further build trust in
products and brands and drive forward the self-care
agenda.
GSK has three priorities: innovation, performance and
trust. Performance, he explained, is about consistently
delivering on consumer needs, which allows GSK to con-
tinue to invest in their brands and people. Innovation is
the life-blood of our industry - and goes beyond prod-
uct innovation to packaging, claims and experience.
He also believes that the interaction between the con-
sumer and pharmacists is critical, and will become more
important with enhancements from digital and data.
Earning and retaining the trust of consumers will be the
key to expanding the consumer healthcare market, ac-
cording to Brian McNamara.
Public trust in systems of government and in business
was at an all-time low, but in the portfolios of consumer
healthcare companies around the world, there were
brands with a great deal of loyalty and trust. To grow
the industry, he added, this asset needs to be leveraged.
Industry, by doing business the right way - ensuring
quality, efficacy and safety can leverage the trust in
the brands that have been in people's lives for many
years, he said.
He concluded by stating his belief that the success of
self-care is founded on three fundamental pillars: one,
putting consumers at the centre; two, enabling self-care
to improve health and healthcare systems; and the final
pillar, building trust in our products and brands. These
are the building blocks of serving consumers and mov-
ing the self-care agenda forward.
6

Performance of the Self-Care Industry
Merger and Acquisition trends and The
Year of the Deal
Fuad Sawaya
Fuad Sawaya, Co-founder and Managing Director,
Sawaya Segalas, a New York-based global boutique in-
vestment bank which exclusively serves clients in the
consumer industry, began his presentation by providing
his perspective on Merger and Acquisition (M&A)
trends. The year 2014 saw deal values greater than the
last seven years combined. This was followed by a di-
gestion year in 2015, and increase in M&A activities in
2016/2017. There has been a record number of scale
transactions and transaction multiples have peaked and
then stabilised somewhat. The entrance of generic com-
panies into the OTC industry have been met with mixed
successes, private equity has become active again and
under the radar, an aggressive consolidator (Prestige
Brands) is on the move that has emerged as a global
top ten, sourcing from private equity, large pharmaceu-
tical companies and from family businesses. He explains
that until this year, the two largest deals involved the
$16.6 billion Pfizer deal back in 2006 and the more re-
cent Bausch & Lomb sale to Valeant. Since then, 5 of
the top 7 deals in size were done in the last 3 years and
it is not just the big pharma companies that are in-
volved in these transactions. There have been asset
swaps, strategic collaborations, private equity involve-
ment and the generic entry with the Omega Pharma
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deal. In the last three years, 13 transactions were in
excess of 500 billion Dollars.
He notes that in 2017, M&A activity has not been ag-
gressive/active like it was in 2014 which was driven by
higher stock prices. He asks what will come next since
most of the chess moves were already played in 2014
and 2016. He adds that focus and prioritisation is the
way forward for the big players. Focusing on the big
ideas, leveraging R&D, putting resources behind them
and making them happen.
We are at an inflexion point. We have not seen an ac-
celerated pace for traditional OTC portfolio optimization
-its very ad hoc. He explains the percolating im-
portance of following the consumer in the industry
and as a result, there is an evolving definition from OTC
to consumer healthcare. As a result of the expanded
definition, there are new competitors and new entrants
looking at the industry from a different perspective.
From a divestment standpoint, we have had three large
deals and very little come out of it However, according
to Mr Sawaya, this may change.
Looking at the industry construct there are 10,000
brands with 50 million Euro or less out there which will
be a source of an extensive trail that will be available for
M&A going forward. In his view, Europe is most likely to
see the most action in the future in terms of those di-
vestitures.
There are increased blurred lines between OTC and con-
sumer health (including functional foods, devices, infant
nutrition, light therapy). FMCG (fast moving consumer
goods) leadership is coming into pharma companies,
and pharma leadership is coming into FMCG compa-
nies, which brings new thinking. For example, in GSK the
combined OTC and FMCG market has been dubbed
FMCH (fast moving consumer healthcare). M&A is now
following those expanded category definitions. For
Reckitt Benckiser, 7 out of their top 10 power brands
focus on healthier lives and more and more companies
are converging towards this messaging.
He concludes by stating that consolidation trend is like-
ly to continue, but will also evolve. He does not antici-
pate more mega deals. However, he believes that as the
financial characteristics of the industry are quite unique,
the industry offers tremendous opportunity.
 (Central and Eastern Europe, Middle East and Africa)
Developing regions drive growth and APAC (Asia-Pacific). In contrast, sales growth has
dropped closer to share growth in Latin America and
China. This has had a knock-on effect on other countries
Andy Tisman, Global Senior Principal, Consumer
dependent on China for their growth such as Australia
Health, QuintilesIMS gave his insights on the consumer
(which had a buoyant market in the last few years due
market. The global OTC market continues to grow at
to its exports to China).
solid mid-single-digit rates. Pharma growth has
dropped, and it is expected that the OTC market may
Market leader Sanofi with a 5.1% share had outstripped
overtake pharma again in the next year or so. The
the others with a 3.6% growth in the OTC market (albeit
strong start to cough/cold in 2016/17 winter season (10
slightly under the market growth rate) due to recent
-15% growth), has not been maintained through Q1
asset swap with Boehringer Ingelheim, propelling it
dropping to less than 5%. He explains that growth is still
ahead of both Bayer and GlaxoSmithKline that had
driven by emerging markets and developing economies.
grown by 1.0% and 2.3% respectively. Their 4.8% market
Developing regions contributed 82% of the growth of
shares were larger than Johnson & Johnsons 4.0% in
the global OTC market that exceeded 100 billion for
fourth place, despite a stronger 3.1% sales rise during
the first time in 2016. This was despite them only having
the year. However, he noted that only PGT (which in-
a 50% share of the market that grew by 4.6% to 101
cludes P&G North America), Reckitt Benckiser and No-
billion Euro at manufacturers selling prices. Two re-
vartis had grown ahead of the market growth rate. In
gions, in particular, are growing very strongly CEEMEA

8

Europe, only Stada and PGT grew ahead of the OTC
market in Europe in the first quarter of 2017. Novartis,
Sanofi and Reckitt Benckiser approached market
growth. Noting that the extent and timing of the cough/
cold season remained a strong influence on the mar-
kets performance the first quarter of 2017 had damp-
ened a buoyant fourth quarter of 2016 and he points
out that none of the worlds top four OTC companies
had done better than the market as a whole.
Andy Tisman
Outside of top 10 Abbott, Stada and Menarini achieved
strong global growth. Abbotts OTC sales had risen by
9.5%, Stadas increased by 8.4%, while Menarinis rose
by 7.9%, driven by the focus areas in their portfolio.
In Europe, France had performed better in 2016 than its
growth rate over the previous three years (due to a
buoyant analgesic market), but Germany, Italy, Spain
and the UK had not done so well. In Central and Eastern
Europe, there is a stronger growth picture driven by
Russia, Turkey and Kazakhstan (local currency growth),
except for Poland which lagged slightly behind.
From a category view, cough, cold, respiratory and vita-
mins and minerals grew ahead of the Europes OTC
growth, while pain and digestive products continue to
see strong growth.
On M&A, he reports that the Sanofi and Boehringer
Ingelheim deal created the No. 1 player in 4 regions and
gives Sanofi consumer health care a strong presence in
Japan. The deal was well matched in terms of comple-
mentary businesses. Within respiratory Sanofis strength
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Conference report
is in anti-allergy, while Boehringer Ingelheims is in ex-
pectorants. And in the gastrointestinal category, Sanofi
core brands in liver remedies, antidiarrhoeals and probi-
otics complement Boehringer Ingelheims core brands
in Laxatives and Inflammatory Bowel Disease (IBS). Their
businesses are also synergistic from a regional perspec-
tive.
He points out that the Reckitt Benckiser acquisition of
Mead Johnson Nutrition extended its focus on mums
to include babies, recalling the keynote address of CEO
of Reckitt Benckiser, Rakesh Kapoor, from the AESGP
Annual Meeting London 2014 that its all about mums
not molecules.
He observes that overall, there is fragmentation in the
market, and a polarised picture, with consolidation at
the top and fragmentation, lower down, as local and
regional player continue to grow strongly and take
shares from the mid-tier players. As a result, the gap
between the market leader and No.10 continues to
grow, illustrating the difference in scale, as the big play-
ers become enormous. There has also been a lot of pri-
vate equity interests, interested in the OTC space.
He notes that innovation remains the key growth driver,
particularly in developed countries (where there tends
to be base volume decline). New products, market ex-
tensions, and OTC switches remain the only way of driv-
ing value in the market. Globally OTC is 41% bigger than
it was 5 years ago in 2011, with 29% growth being
through new products/line extensions, 9% through price
increases of existing products and 3% through volume
increases of existing products.
Looking to the future, Tisman highlighted the
increasing leverage of combining research and devel-
opment and consumer insights to drive differentiation
and growth. Switch is being leveraged as a growth driv-
er with successes and failures. The market continues to
broaden from OTC to health and wellness, he observed,
with medical devices potentially offering a faster go-to
-market innovation route. Chanel mix and go-to-
market continue to be important and companies contin-
ue to face the challenge of resource splitting between
the direct-to-consumer, the healthcare professional and
the trade customer.
Overlaying all of that, he says is the rise of digital
which is playing an ever more important role, both in
terms of promotion and a route of distribution for prod-
ucts. He also notes that increasingly companies see the
value in open innovation.
He concludes by stating that the OTC market continues
to show steady growth and attract new competitors.
Mega-deals have driven corporate growth. The question
is how can those in the middle ground avoid the
squeeze as the local and regional players continue to
grow strongly.

Market perspective

Chris Slager, Global President, Pfizer Consumer

Healthcare presented his perspective on the OTC busi-
ness coming from a food industry background. He be-
gins by comparing and contrasting the two industries
with some market fundamentals. Looking expansively,
he comments that both are very large. The food indus-
try is a $3 trillion market. OTC Health and Wellness is
about $2.5 trillion and incorporates functional nutrition,
personal care, hygiene, wellness services, consumer
health equipment and wearables. Chris Slager

The biggest trend in both businesses is the growing

Both have similar global compound annual growth rates
interest in wellness and the consumers focus on well-
(CAGRs). There are mid-single digit CAGRs which con-
ness is blurring the lines between OTCs and food as
tinue to grow. Both industries have a diverse set of
consumers are seeking wellness solutions. Consumers
competitors. Who really is the competitor is changing
are looking for a quality experience which he describes
everyday as the consumers perspective changes. He
broadly with the terms trust, ingredients, and conven-
also notes that regulation is another area where the
ience. He explains that consumers want brands they
food and consumer healthcare businesses overlap.
can trust against the backdrop of a global decline in
institutional trust.
Both businesses are characterised by significant pricing
and margin pressures given retail consolidation. He
Trust is higher with small businesses than big ones and
points out that increasingly, we can see consolidation in
the gap is widening. According to the Gallup poll, confi-
food and OTCs as a way to gain scale and manage
dence in small business has increased by 6 percentage
costs/profitability. One significant difference between
points between 2014 and 2016, while confidence in big
businesses is the prescription to OTC switch. In the
business has declined by 3 points. He explains that the
food industry, he concedes, the ability to dramatically
same trend is evident in the food industry. He explains
increase revenue and income doesnt exist.
that Nielsen data show how these trends are impacting

10

the processed food business. Small and medium brands
account for 35% of sales, but an overwhelming 75% of
growth. While the top 50 brands still account for the
majority of sales, it is smaller brands that account for
growth in the market of the top 50% of brands account-
ing for only 3% of growth.
When consumers trust a brand, they try more, buy more
and pay more, which leads to a greater market share for
smaller companies. He explains that this trust is chang-
ing the way consumers vote with their dollars day in
and day out.
From an ingredients standpoint, consumers are looking
for more accessible information. Consumers gravitate
towards buzz words like organic because of connota-
How to Be Successful in Self-Care
Olaf Schwabe, Chief Executive Officer, Schwabe, de-
scribed the history of his company, Schwabe, which cel-
ebrated its 150th anniversary in 2016. It was founded by
Dr Willmar Schwabe who was his great great grandfa-
ther in Leipzig. In 1878, the first phytopharmaceutical
product, Hametum, was developed. In 1946, the compa-
ny relocated to Karlsruhe and, in 1961 DHU, which is
specialised in homoeopathic products, was founded.
Olaf Schwabe
Schwabe has a presence in all five continents. Relevant
Research and Development (R&D) investment takes into
account the focus on self-care. Home market sales grew
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Conference report
tions of trust and a quality experience. Consumers also
want convenience. E-commerce and the growth of mo-
bile shopping and options such as click and collect
indicate where investors see the future of retailing.
He remarks that the theme of the conference Self-care
in a changing world is very appropriate, given trends in
the market; focus on wellness; the blurring of lines be-
tween food and OTCs; and consumers desire for brands
they trust, leading to a demand for a quality experience.
Our consumers are shaping this, he says and we need
to keep a focus on consumers needs. Thinking
through how to build trust, better ingredients and deliv-
er convenience, he says will help us to deliver self-care
in a changing world.
by 11 % from 2013 to 2016 and international sales grew
in the same period by 42 % - now representing 3/4 of
Schwabe Group sales. It had seen major growth in
North America and China. Tebonin is their biggest
brand with approximately 30% of the total sales volume.
Launched in Germany in 1965, Tebonin the first ever
Ginkgo medicine gained the number one position in
the German pharma market in the 1980s and is the
number one Ginkgo brand worldwide. Ginkgo biloba
Special Extract EGb 761 is approved for the treatment
of cognitive disorders, tinnitus and vertigo. Analysis
over 10 years and almost 400 batches of EGb 761
found that it has a unique, consistent composition,
while other ginkgo extracts differ significantly, he said.
Schwabe has its own Ginkgo plants and decades of ex-
perience in creating batch to batch consistency for EGb
761 with a patented 20+ step extraction process.
More than 50 randomised controlled clinical trials with
more than 7.000 patients and several meta-analyses
confirm efficacy. Tebonin is included in therapeutic
guidelines related to their indications in many countries
in Europe as well as outside Europe.
All non-prescription medicines in Germany were exclud-
ed from reimbursement by public health insurances in
2004 following a package of cost containment measures
which were a significant threat to Tebonin, as more
than 60 % of sales came from prescription. However,
Schwabe was able to even increase sales with a two-
step strategy: Medical doctors were re-assured of the
therapeutic benefits of Tebonin and convinced to fur-
ther recommend Tebonin (without reimbursement or
only coverage by private insurance) and investments in
direct to consumer communication were increased (e.g.
TV promotion). Schwabe also extended its business in-
ternationally to become less dependent on the home
market.
Tebonin is now available in more than 50 countries.
The most recent countries include India and Israel. Inter-
national sales have almost doubled in 5 years. He ex-
plained that the success is based on the fact that it is of
high quality and clinically tested. Manufacturing takes
place in Germany and, by that, an excellent quality is
produced close to the customer.
Germany at the beginning of this month and will be
rolled out in Europe soon.
The Schwabe business has significantly changed in the
past 150 years. He concluded by saying that, as a family
company, Schwabe will continue to strive for innovative,
efficient and safe solutions for various health issues with
products from nature according to their vision: From
nature. For health.
Succeeding in smoking cessation through
consumer insight and innovation
Catherine Devine, Global President, OTC Franchise,
Johnson & Johnson, gave an example of a success story
based on consumer insights and partnering with the
consumer. Rather than focusing on the functional char-
acteristics of its products, Nicorettes mission is to save
the lives of consumers by being the partner of choice to
help smokers take control of their quit journey and
break free from tobacco for good.

To further remain successful, it is important to identify

relevant consumer needs and trends and adapt accord-
ingly. There is no doubt that health will remain a mega-
trend especially as the global population gets older. In
less than 30 years more than 1 billion people will be
over the age of 65. Often the industry is asked to offer
convenient solutions for different health issues. But he
explained that the 65-year-olds of the year 2050 are
today in their early 30s and in many ways they will be-
have differently not only in media usage but also in
expectations towards a more individualised medicine.
He explained that this is one of the reasons why we
need to transform, from being a manufacturer and
marketer of medicines to a company that offers individ-
ual health solutions.
Digitalisation will be key in this process, he said. He
gave the example of a newly developed Tebonin App
with exercises for Vertigo sufferers. This innovative solu-
tion ensures an individualised exercise programme that
reflects the specific needs of the user. It was launched in
Catherine Devine
The smoking cessation category is important, as there
is still a significant number of smokers in the world in
total 1.4 billion which is the current population of Chi-
na. Contrary to all political efforts, smoking is expected
to continue to rise in the next 20 years. Smoking has a
known and significant negative impact on health. The
World Health Organisation (WHO) cites six million
deaths from tobacco and causes hundreds of billions of
dollars of economic damage worldwide each year. If
current trends continue, by 2030, tobacco will kill more
than 8 million people worldwide, she quoted. 86% of

12

all lung cancer in the UK are linked to smoking, she
added.
The dangers of tobacco are becoming more known;
hence consumers are trying to quit smoking. However,
many underestimate how difficult it is, with most people
in need of numerous attempts to successfully quit and
many never managing to do it. Quitting is made diffi-
cult because of the physiological addiction from nico-
tine and the physical, emotional, situational and social
addictions that comes with giving up smoking. As it is
most personal, it can feel that smokers are giving up
part of who they are they are defined by their smok-
ing, and are fearful of what it means if they are not a
smoker any longer.
In order to be able to help a quitter to give up smoking,
Nicorette built on these consumer insights of the quit-
ting journey and developed an innovative approach in
many senses in relation to communication. From this,
Nicorette came up with their slogan: Do Something
Amazing.
It speaks to the huge sense of achievement that comes
with finally beating smoking and the opportunities it
can open up. Mrs Devine explained that it is very moti-
vating to speak to smokers like people, not patients,
and applauded those who are brave enough to try and
quit and it focused on the positive end goal, not just
the struggle.
Their latest innovation QuickMist also leverages the key
consumer need around those tough struggle mo-
ments. QuickMist provides the fastest craving relief in
the category and is supported by strong claims (150%
more likely to quit, relieves cravings in 60 seconds).
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Conference report
Nicorettes approach to insight-led innovation has re-
ceived a number of recent recognitions and awards.
Through insights, Nicorette was able to create truly
consumer-led innovation (communication, product, and
channel innovation) to ultimately help consumers break
free from cigarettes and live a longer, happier life, she
summarised.
On digitalisation, she explained that to stay current in
what was a rapidly changing digital environment, com-
panies could afford to take a leap into the dark on
new digital services. Generally, digital activities were
low cost and so companies could afford to throw a lot
of things out there. If you are not having failures [in
digital], you are not moving fast enough, she insisted.
She warned delegates of the conference that we need
to get comfortable with having two-way conversations
with consumers in the digital space or become irrele-
vant.
Consumer centricity, digital and partner-
ships
Dirk Ossenberg-Engels, AESGP Vice-President and
Head Region Europe South, Central Eastern Europe &
Middle East, Bayer Consumer Care, began by acknowl-
edging that we are in an exciting and challenging mo-
ment for self-care. He asked the audience what is the
reason they get up in the morning, is it to sell boxes
or to make an impact on consumers and society?
He went on to explain his perspectives on how to be
successful in self-care, which in reality features a combi-
nation of consumer centricity, digital and partnerships.
He explained that consumer behaviour is changing
more rapidly and is becoming more diversified. It is
therefore increasingly important to address consumer
needs, and pick up on nuisances to find targeted solu-
tions for consumers.
He then gave an example of turning a consumer insight,
driven by a medical need, into a clear tangible benefit
with a line extension. One of Bayers franchises, Copper-
tone, is based on a consumer insight that the single
biggest barrier to applying sun protection is how the
cream feels on the skin. It also addresses the need to
prevent skin cancer, which is the number one cancer in
the US and is growing. Coppertone whipped launched
into 2017 and has been the recipient of a number of
awards.

Dirk Ossenberg-Engels
The future is not digital, he said, keeping the audience
in suspense, the future is now. 60-80% of consumers
use smartphone today. It is a reality for our consumers.
$1.9 trillion was the turnover through e-commerce in
2016 and this is expected to increase. Digital can be
used as a platform to provide services, information and
engage with consumers.
Bepanthen, he explained, is based on a consumer in-
sight that after pregnancy, the attention shifts from the
mother to the baby. They then developed the 10th-
month initiative. He then showed a video illustrating the
emotional bond they created with this initiative.
Launched in Turkey, in a few weeks it was seen by 2 mil-
lion people. The website is also now online in nine
countries, six in Europe.
Big data is expected to double every 24 months. He
gave an example of the product Aleve in the US which
made use of big data. The company received feedback
from consumers for a non-systemic alternative, and big
data, online threads were used to confirm this gap in
available treatment. They partnered with the TENS
(transcutaneous electrical nerve stimulation) technology
and launched Aleve direct therapy in 2015.
We are getting in better on digital partnerships, he
said. Ossenberg-Engels then described some non-
commercial partnerships, which he believes companies
should develop. Bayer has partnered with 18 stakehold-
ers including the White Ribbon Alliance (which advo-
cates for mother and babys rights and health), the Unit-
ed Nations where Bayer participated in the Every Wom-
an, Every Child Movement and WHO to launch a poli-
cy position on the role of self-care in maternal, new-
born and child health.
Success in self-care ultimately provides a unique bene-
fit to consumers, society and health care systems, he
concluded.
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 Conference report

The Changing Environment for Health Professions

From left to right: Jacques de Haller, President, Standing Committee of European Doctors (CPME); Briain de Buitleir, CEO,
PGT Healthcare; Cristina Cabrita, Senior Project Officer, Deco Proteste, representing the European Consumer Association
BEUC; Jurate Svarcaite, Secretary General, Pharmaceutical Group of the European Union (PGEU); Lilian Azzopardi, Presi-
dent, European Association of Faculties of Pharmacy (EAFP); Max Wellan, President, Austrian Chamber of Pharmacists

A key prerequisite for a positive development of self- money is better spent on prevention, diagnosis, and
care remains the attitude and support provided by pharmacogenomics. Prevention is accelerating at an
health professionals including in particular medical doc- enormous rate, he said, and elaborated on this with an
tors and pharmacists. Leading representatives of the example of capsules which can be injected into a per-
professions discussed concrete ways forward in times of sons hand to read blood and act as a security mecha-
growing consumer empowerment and an unprecedent- nism.
ed variety of information. Briain de Buitleir, Chief Exec-
utive Officer, PGT Healthcare, introduced the session by CPME supports Self-Care
saying that we are all in the same business, healthcare
professionals, regulators, because our business is giv-
Jacques de Haller, President, Standing Committee of
ing patients longer, healthier lives and in this business
European Doctors (CPME), first introduced CPME, which
the demand is insatiable. This is creating a crisis for the
is the umbrella association for the National Medical As-
pension industry as people live longer lives. He remarks
sociations of 28 countries in Europe. It represents both
that we are at an inflexion point because there is the
General Practitioners and specialists and, by that, more
question now of whether this rate can increase further.
than 1.5 million doctors. CPME articulates the medical
Self-care has an important impact on this rate.
professions point of view to EU institutions and Europe-
an policy-making through pro-active cooperation on a
Looking ahead, he said, self-care and the professions
wide range of health and healthcare related issues.
have increasing opportunity to make a positive impact
and better tools and technologies to do it with.
The key point of Dr de Hallers presentation was an ex-
planation of the outcome of the EU-funded pilot project
Of the money spent on helping people live longer, 80%
on the promotion of self-care systems in the European
is spent on chronic disease. However, he believes that
Union (PiSCE), which has been developing and produc-

15
 Existing self-care related EU policies

ing communication tools and a series of proposals and indicated that they are ready and willing to bear neces-
EU policy recommendations and actions on self-care. To sary costs of self-care (reflecting an understanding of
come up with the recommendations, three main meth- the importance of self-care).
ods were used: review of existing self-care related EU
policies; a survey on the needs of people/patients; and
input of the PiSCE Platform of Experts. This began with
a mapping of existing European self-care initiatives,
which found, for example, that patient safety is at a
more advanced stage of implementation compared to
health literacy.

The main findings of the survey on the self-care needs

of people/patients conducted by the European Con-
sumer Organisation (BEUC) and the European Patients
Forum (EPF), identified that the needs of persons ex-
posed to self-management interventions were health
information, access, support from healthcare profes-
sionals, patient groups and families. The main barriers
to self-care were low health literacy, costs of self-care,
difficulty to navigate the healthcare system and lack of
information. The survey also found that vulnerable
groups should be the main target when developing and
implementing self-care policies. 65% of respondents Jacques de Haller

16
 Conference report

Themes brought up by the PiSCE Platform of Experts letes foot. These were selected after a benefit-cost
include empowering patients to be more internet- analysis by the European Commission.
savvy in terms of judging the quality of information,
empowerment through knowing when to seek profes-
sional advice, good inter-professional cooperation and
the need to educate pharmacists, doctors and patients
to change their behaviours.

The EU Policy Recommendations integrate new tech-

nologies to support peoples self-care (making health
information easily accessible for patients to make in-
formed decisions), embed self-care in health literacy
initiatives (which is still not usual practise), to establish
a framework that will encourage the exchange of best
practices on self-care, to secure an Engagement Plat-
form to support national or regional initiatives on self-
care, and to include self-care in school education and
life-long learning to teach young people how to man-
age their health (which, Dr de Haller remarked, was a
strong proposal of the PiSCE project). The inclusion of
skills to support self-care as part of the curriculum in Cristina Cabrita
education and training of health professionals was also
part of PiSCE project. The self-care platform, she explained, consisted of 23
experts on self-care from all over the EU with expertise
He stated that CPME supports self-care, commenting in self-care: self-management, patient empowerment,
that the association has been fighting prejudice about health literacy, integrated care, health technologies, self
this for years. Self-care supports and enhances the dig- -medication, and expertise related to EU, national and
nity of patients. However, he believes that self-care regional levels. Experts are individuals with affiliations
must not lead to or permit missed or belated diagnosis, that represent central actors needed for EU, national,
lead to wrong or dangerous use, to the abuse of medi- regional and local levels on self-care: primary care phy-
cations, or be used as a commercial lever (as patients sicians, pharmacists, nurses, patients, academia, com-
arent just consumers). munication specialists, consumers, the self-medication
industry, etc.
Self-care will change lots of things over the next 20
years, including the professional identity of doctors, Part of the project was the carrying out of a survey to
pharmacists and other healthcare professionals. identify barriers for practising self-care.

He concluded with the following remark that self-care
belongs to society as it develops nowadays [] and it is
essential that health professionals be realistic members
of the society. He also remarked that self- care should
play a greater part in our health systems.
PiSCE Recommendations
Cristina Cabrita, Senior Project Officer, DECO
(Portuguese Consumer Organisation), Proteste, Portu-
gal who works as an expert in the PiSCE project talked
more about the policy recommendations of the PiSCE
project, which covers five minor disease areas, namely
cough, cold, urinary tract infections, heartburn and ath-
Weak health literacy, she explained, leads to less
healthy choices, less therapeutic adherence/
compliance, riskier behaviour, poorer health, less self-
management and more hospitalisation.
Around 50% of people have difficulties when trying to
use Internet to look for health-related information.
This was related to not having the skills to evaluate the
health resources found on the Internet and difficulties
to find correct health-related information. Functional
literacy was also assessed and revealed difficulties
when asked to use simple information to manage the
administration of a drug.
Health literacy and self-care in early childhood are criti-

17
 Barriers to self-care according to PiSCE survey
cal, she explained, and interacting with parents and
family members through early childhood programs is
important, e.g. through child-to-child programmes.
Children can then teach parents about self-care. It is
therefore important to equip teachers to integrate self-
care in schools and in the curriculum. She then gave
examples of videos, play games which were developed
to test health knowledge, run by the Finnish Medicinal
Products Agency, targeted to each year school. It should
be lifelong learning and be either informal through daily
reading or formally structured.
To include self-care in health professional education,
this requires skills, knowledge and attitudes from
healthcare professionals, to treat the person as an indi-
vidual, to actively listen, communicate and set goals
together.
She concluded by stating that self-care needs to be evi-
dence based, with teachers and parents on board and a
political will behind it.
Community Pharmacists and Self-care
Jurate Svarcaite, Secretary General, Pharmaceutical
Group of the European Union (PGEU), began by noting
that surveys from the European Consumer Organisation
(BEUC) and the European Patients Forum (EPF) shows
that patients are more willing to make self-care deci-
sions. Self-care is not just self-medication but includes
anything patients do to care for themselves. She ex-
plained that increasingly patients are seeking holistic
care, not just seeking treatment as a condition, as a
migraine for example, but to be treated individually to
maintain their health and stay active members of socie-
ty. Healthcare is not just about treating diseases. It is
also good for the economy as people can continue to
live their usual lives. Pharmacists can act as gatekeepers,
to refer/signpost the patient as appropriate, highlight-
ing that inter-disciplinary collaboration is important.
However, she explains that self-medication is a tool to
provide immediate support.
On the PiSCE recommendations, she added that the
greatest strength of the project, for the pharmacists,
was sitting down and discussing the ideas together as a
healthcare team even though the recommendations
could have been a little more challenging.
Reflecting on earlier discussions on digitalisation, she
explained that the world is changing and healthcare
professionals are also changing. The pharmacy profes-
sion was one of the early adopters of technology, and
are increasingly writing blogs and interacting with pa-
tients through other channels, for example, pharmacy
Facebook pages.
Alluding again to changing patients, she explained that
we [healthcare professionals] need to change with
them.
18

Jurate Svarcaite
Access is not just about having a pharmacy around the
corner, and her vision is for community pharmacy to
be the smart care around the corner.
Shifts in pharmacy education
Lilian Azzopardi, President, European Association of
Faculties of Pharmacy (EAFP), began by describing the
challenges for pharmacists in managing complex pa-
tients, handling big data, complex therapies and from
an industrial perspective, how production facilities are
19
Conference report
affecting the environment. When EAFP was set up, it ran
a curriculum mapping exercise, which found that chem-
istry subjects dominated the curriculum. In 2006 anoth-
er curriculum exercise was run, which showed a shift in
focus to the medical sciences in pharmacy curricula.
Leufkens, with leaders in clinical pharmacy in the 1990s,
came up with a model that for pharmacists to maintain
their position as healthcare professionals, they need to
put the patient first, be proactive, and partner with the
patient and other healthcare professionals towards im-
proving self-care.
This shift in education was confirmed by a publication
in 2016. The curriculum with the highest mean percent-
age of clinical sciences was the United States at 16.7%
followed by Malta and the Netherlands at 12.3%.
This shift in education goes hand in hand with the need
to maintain knowledge and merge science. Realising
that practice is changing and that patients need to be
supported to navigate health information are important
prerequisites to make change happen.
The future vision is to include clinical pharmacy, and
pharmacy practice as subjects in the EU Directive on
Pharmacy Education, and to support the development
of faculty and opportunities for research in self-care.
At the University of Malta, there is a post-graduate pro-
fessional post doctorate in pharmacy (EU-USA collabo-
rative degree) which focuses on self-care and empower-
ing patients. A third-year student of this programme
completed a research project on Optimising Patient Self
-Medication through the Community Pharmacist which
identified that out of 203 patients reviewed in commu-
nity pharmacy, 38 (19%) had at least one drug-related
issue.
At their recent annual conference in Helsinki, EAFP re-
flected on the challenges and what needs to be done
from an academic perspective. The conclusion was that
there is a need to maintain the science-based aspects of
the curriculum, to have lifelong learners, individual pa-
tient inspiration, interdisciplinarity, and be able to deal
with new therapies, innovations, health systems, and
technology.
Pharmacy education rather than looking at subjects
should look at the competencies graduates need to
contribute to self-care, to look at what is needed in
pharmacy education and how the future should be
shaped, she concluded.
Pharmacogenetics and ApoApp
Max Wellan, President, Austrian Chamber of Pharma-
cists, began by explaining that patients and people are
mobile. Seven years ago, apps provided on medical/
Lilian Azzopardi
pharmaceutical information but did not provide trustful
information. Now ApoApp, by the Austrian Chamber of
Pharmacists, is the number one app in healthcare in
Austria for six consecutive years. It provides information
on pharmacy opening hours, contact information and
information about medicines. They also invited the self-
care industry to provide additional tutorials about their
products, so that it can be accessible from the app. It
contributes to health literacy by having all the infor-
mation at hand and also signposts when to seek a phar-
macists advice.
Apoatschool is an app designed to equip pharmacists
to go into schools and signpost red flags to look out for
(which meets a PiSCE recommendation to include self-
care in school education). He remarks that patients are
not consumers but are the co-producers of their health,
pharmacists are co-producers, and we are all co-
producers of health.
The Austrian Chamber of Pharmacists also ran a phar-
macogenetic project in the form of a self-experiment
and invited pharmacists to make their own pharmaco-
genetic profiles. This project would enable pharmacists
to counsel patients on pharmacogenetics and to pro-
vide information to doctors. He remarks that a lot of self
-care products are also connected to pharmacogenetics,
highlighting the need for pharmacogenetic counselling,
as an additional safety step for self-care products.
Max Wellan
20

Digital Revolution Self-Care Revolution
One of the most exciting trends in healthcare is the
more and more visible impact of digitalisation. The ses-
sion, moderated by Alan Main, Executive Vice-President,
Sanofi Consumer Healthcare, provided an overview of
the challenges for the industry as a whole and the op-
portunities resulting from the developments in the digi-
tal space. An important part of the session was dedicat-
ed to the developments around the use of big data.
Alan Main
Alan Main introduced the session by describing the
positive implications of digitalisation for self-care, also
making reference to the recent ransomware attacks, and
the need for increased vigilance. He explained how digi-
talisation has had the biggest impact on the capability
of systems: Diagnosis (such as advanced MRI scans to
detect prostate cancer), treatment (using nanotechnolo-
gy), monitoring (remote monitoring cardiac devices)
and mobile health apps. This digitalisation is empower-
ing patients, who now want to play a more active role in
their own health, he said. He also remarked that digi-
talisation could be used as a mechanism to build trust
with patients.
Data is often uncensored and unviewed. Main quoted
that 85% of data was created in the last two years. Re-
ferring to a US survey, Main noted that 80% of people
are willing to share data if they believed it would im-
prove health outcomes for them individually. 60%
would share their data for health research, and 40%
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Conference report
would share information for money. He noted that 85%
of people would be willing to share information with
healthcare professionals, 40% of health insurance com-
panies (for discounts). Interestingly, 16% of people
would be ready to share healthcare information with
industry, 8% with Tech businesses and 8% would share
health information with the government.
He concluded by saying that the data is there, and peo-
ple are willing to share it. The question is: how are we
going to capture that?
What do big industry players think?
Brian Ager, Secretary General, European Round Table
of Industrialists (ERT), opened his presentation by ex-
plaining who and what the ERT are. Members include
55 Chairmen and CEOs of major European multinational
global companies, he told delegates of the AESGP con-
ference. These multinationals are primarily cross-
sectorial and cross-country industrials, he explained.
Since the 1980s, one of its early objectives was to stimu-
late and establish the European Single Market. ERTs
vision is to strive for a strong, open and competitive
Europe, with the EU as a driver for inclusive and sustain-
able growth.
Its priority concerns at the moment are the stabilisation
and promotion of the European Union without the UK,
the impact of globalisation on citizens, and to maintain
and strengthen transatlantic relations and open trade.
Some of it workstreams, each led by a CEO, include en-
ergy and climate change, trade and market access, soci-
etal changes (arguing for the best prospects for youth
employment), gender diversity, encouraging entrepre-
neurship, and digital. Outputs then feed into its contact
programme with political leaders. ERT meets regularly
with political leaders such as Chancellor Merkel or the
European Commission President Juncker.
Digitisation offers opportunities for all industrial sec-
tors, he purported. It is a driver of growth, competi-
tiveness and jobs (for the private, public, and govern-
ment sectors), and to regain its industrial strength, Eu-
rope needs to embrace the new digital society, he ex-
plained. It will also demonstrate that the EU can deliv-
er, he added.
 Brian Ager
He explained that ERT policy priorities on digitalisation
are to deal with the high level of Cybersecurity required,
improving connectivity in Europe by investing in tele-
communications infrastructure to overcome barriers to
the single market fragmentation and harmonisation and
cross-border cooperation. He highlighted the need for
a real European Digital Single Market with all mem- as information sharing, communication, entertainment,
ber states working together in the same structures.
On digital data, free flow of data is vital. He comment-
ed that the General Data Protection Regulation (GDPR)
is not bad regarding setting out a level playing field for
Europe, but the e-Privacy Regulation duplicates and
counteracts it. We are moving fast, and Europe must
optimise its involvement if we are to succeed and move
forward in the coming years.
Customer experiences in the digital world
Max Orgeldinger, Senior Digital Strategist, at Torben,
Lucie und die gelbe Gefahr (TLGG), a digital agency, de-
scribed how digital experiences could affect patient be-
haviour with the example of a Taco Bells Snapchat ac-
count. It is always interesting to see the peculiar expe-
riences that can arise when new technology arises, he
remarked.
One of the most significant current trends is the dra-
matic increase of smartphone devices over the last few
years.
An example he gave of a company profiting from in-
creased mobile technology was Instagram. Founded in
2010, it was bought by Facebook and is now worth $55
Billion, far above the value it generates.
Max Orgeldinger
Smartphones are now surpassing desktop computers
and the number of microprocessor transistors in a giv-
en space is doubling every 18 to 24 months.. This
means smaller, faster, cheaper technology that is ena-
bling all kinds of experiences. Orgeldinger explained
that these tend to be simple experiences, in areas such
and transactions. But more importantly, it will reinvent
a given behaviour around the technology that has
emerged.
Technological progress is creating new possibilities at
exponential growth rates, but not all companies are lev-
eraging this. CEOs dont all take these developments
seriously, such as how Netflix was perceived in the be-
ginning, he noted.
Technology takes the path of least resistance. It is diffi-
cult to force internet experience on users, and even if it
may currently control customer experience that doesnt
mean they will continue to follow that experience, he
explained. Successful companies have become a verb to
own that experience, for example, Twitters experience is
to tweet. They then get customers used to associate
that experience with their service.
Companies that reinvent experiences around techno-
logical changes often see robust growth, he remarked.
Convincing customers to adapt new behaviours re-
quires extremely refined experiences and creating these
experiences requires companies to take digital serious-
ly, he reminded delegates at the AESGP Annual Meet-
ing.
22

Age of disruption and opportunity
John Walsh, Co-founder of Smart Insight Lab, referred
to the Fourth Industrial Revolution and remarked that
there has never been a more interesting and challeng-
ing time to live in than today in terms of technology
and business. He emphasised the importance of ethics
and what do we want as a company/individual to go
forward. Social Media will help us to move forward, he
explained, and empower people more to decide what
they want. Digital is the driving force (oxygen), with
customers at the heart, and people as the soul in the
company/organisation.
He reflected on the 2020 healthcare landscape where
informed and demanding patients are now partners in
their healthcare. In the era of digitised medicine there
would be new business models to drive new ideas.
Wearables would be used to measuring the quality of
life rather than just being clinical indicators. Health data
and big data will be pervasive requiring new tools &
models.
This business is lagging behind, he said, as some com-
panies face problems from new competition, emerging
technologies, the explosion of new data and psycholog-
ical/behavioural economics. A Deloitte survey on where
healthcare is going found that healthcare is a moving
environment which is lagging behind, and needs to be
moving faster and better.
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Conference report
He remarked that there is minimal data out there on a
girls headache since there is little open data and
closed data is expensive to access. More and more
people are going online/on Social Media/Google to see
if there is a knowledge base available to consult before
buying. Massive time is spent on building a decent
knowledge base, he said.
He reflected on the importance of social engagement
and intimacy involved in selling information about a
product and giving customer an experience. We have
been so focused with disruption we were not looking
at the bigger picture, he said. In his view, a 2030 strate-
gy needs to be developed to incorporate the 4th indus-
trial revolution scope and digital and data strategies.
There is a need to focus on corporate digital transfor-
mation programme, the full journey, and to refresh the
existing operational model(s), he said. Customer and
business adaption to the new GDPR is required. Howev-
er, he warned that if business adaption to GDPR is too
slow, it will lag behind. He also recommended that
pharmacy sites become more integrated, open to en-
gaging the customer. New business models to engage
customers are also required, he explained.
As we move from big data to smart data, as he pre-
fers to call it, his advice to OTC companies was to take a
broader longer-term view. We are currently focused on
disruption, he said. Now is the time to look at the big-
ger picture and develop a robust digital and data strate-
gy.
Smart data helps build wise companies to think ahead.
He explained that machine learning would become big
in the next two to three years (and has already been
introduced with Microsoft Office 365). He also remarked
that at least one in ten big data projects fail to meet
their objectives.
He concluded with some key messages on data privacy
and the new General Data Protection Regulation which
guards private and personal data. There is an oppor-
tunity to build trust with customers and value-driven
approach and in doing that we should see GDPR as a
value proposition, he said.
Finally, he raised the question how can we regain data
and commented that popular search terms dont in-
clude Europe and recommended a single platform for
online health information.
Thomas Senderovitz, Director General, Danish Medi-
cines Agency, Denmark, explained that nowadays tech-
nology development is exponential. Patients are be-
coming consumers; the population is ageing and data is
big.
Every 24 months the volume of electronic healthcare
data doubles he explained. There are more than 210
exabytes of available healthcare data today, he stated.
90% of the worlds data has been created in past two
years. However, 80% of data is unstructured, so the
challenge is how to make sense of this data.
Another problem is turning big data into knowledge
and knowledge into decisions, regulatory decisions,
pharma decisions, and medical/scientific decisions. He
explained that the work plan of the joint Heads of Med-
icines Agencies (HMA)/European Medicines Agency
(EMA) Task Force on Big Data, of which he is co-chair, is
John Walsh
to characterise relevant sources of big data and define
the format. Sources of big data include genomics and
other omics, observational data, clinical trial data, So-
cial Media health, IT/infrastructure and spontaneous
adverse drug reactions (ADRs). Other objectives in the
work plan are to identify areas of usability and applica-
tion of datasets, describe the current status, future
needs and challenges and generate a list of recommen-
dations and a Big Data Roadmap.
Recommendations for how European regulators should
deal with the exponential growth of big data will be
made in just 18 months time, he promised. We cannot
spend the next five years working on a guideline it
would simply take too long, he said. Regulators can-
not ignore the role of real-world data after drugs have
been approved, he added.
He also highlighted the role of Social Media, wearables
and sensors in generating post-approval data. We have
to look at data differently, and we have to devise differ-
ent ways of making decisions, he explained. Drug de-
velopment and approval had been a linear process tra-
ditionally, but the timescales now were such that in fu-
ture some of the regulatory work would have to be car-
ried out in parallel, he believed.
Data quality was an issue for Senderovitz who was dubi-
ous that the algorithms that were being used in health
apps had been properly validated and were making the
right recommendations. More and more, its a black
box, he said.
He concluded by stating that big data is relevant for
regulators, sponsors, healthcare professionals and citi-
zens/patients and that the HMA/EMA has started to
address the challenges and opportunities that come
with big data.
Thomas Senderovitz
24

Ehealth Facilitating Self-Care
Laurent Faracci
The session, moderated by Laurent Faracci, Global Cat-
egory Officer and Head of RBs Category Development
Organisation for infant and child nutrition, discussed
what digitalisation means in concrete terms, what the
role of companies like Google and Facebook could be
and how European consumers see these developments.
Acquiring Mead Johnson created an inflexion point in
the growth of RB as a business and will have a signifi-
cant impact on RBs consumer health portfolio, accord-
ing to Faracci.
It increases the firms consumer healthcare franchise by
90%, he added. The deal which is expected to close in
the third quarter of 2017 would also considerably in-
crease its market presence in Asia.
Introducing the topic of the session, Faracci also made
reference to the increased use of mobile phones and
decrease in time spent watching TV. He also noted that
increasingly voice is beginning to replace typing in
online queries. 20% mobile queries were made via
voice in 2016, and the accuracy is now about 95% he
explained.
Googles potential in the healthcare space
Karl Pall, Director Brand Solutions, Google, started off
his presentation by giving background on where Google
sees itself sitting in the health area. Googles mission is
25
Conference report
Karl Pall
to organise the worlds information and make it univer-
sally accessible and useful. So, it should not be a sur-
prise that since the beginning we have always seen our-
selves as an outlet for information about healthcare, he
said.
Digitisation has rewritten the rules of the game in
healthcare information. The internet is now the number
one source for healthcare information. Information is
just a fingertip away. Many people look at their phones
150 times a day.
The result is that there are now billions of healthcare
queries every day. In Germany alone, there are more
than 6.2 billion per year, he quoted. One in 20 searches
on Google is health-related. It is one of the most
searched topics on Google, and it is growing, with query
growth rates of around 10%, he explained.
Google is the worlds largest database of intentions
people ask Google everything. Google can, therefore,
offer a broad array of publicly available tools by aggre-
gated search data, and thus can help provide valuable
consumer insights by understanding the patient/
customer journey better and help provide the right in-
formation to consumers/patients.
Over 85% of people who use the Internet say that
when they have a health concern or question they begin
at a search engine like Google to find information.
Therefore, Google has taken the responsibility of bring-
ing health information to consumers/patients and have
enhanced their health search functionalities over the
years, most recently with things like the health
knowledge panel which shows up on the right side of
the screen on a desktop or the top of the screen on mo-
bile when a query around a condition is entered. He
explained that data are vetted by 11 physicians and ap-
proved by Harvard Medical School and the Mayo Clinic.
Google also sees some health trends. He explained
that each time someone searches for a health-related
term, a drug name or condition; it provides an insight as
to how consumers are seeking to learn about their
health. So understanding this data is something that is
very important to Google as we think about what our
next big bets are, he explained.
Facebook keen to partner with Healthcare
industry
Leigh Thomas, Director of Global Client Partnership,
Facebook, said that Facebook was interested in partner
with consumer healthcare companies for the good of
both the healthcare industry and the over a billion peo-
ple that used the platform.
Leigh Thomas
She began by explaining that healthcare was built on
trusted relationships, and people come to form their
relationships now not just on Facebook, but on mobiles.
She quoted that 1 in 5 hours of people's time on mo-
bile is spent on Facebook and Instagram, which she
explained is a tremendous opportunity, and can
change our behaviour.
Facebook Healthcare groups are one of the fastest
growing. By joining a group, she explained, you be-
come part of a valuable community, where members
support and encourage each other. She gave an exam-
ple of at-risk men who joined an HIV prevention group
on Facebook that was eleven times more likely to re-
quest an HIV testing kit.
Doctors also use Facebook personally and professional-
ly, and she highlighted the research on this topic. For
example, when asked, 65% of physicians surveyed indi-
cated interest in engaging with clinical data via social.
Healthcare is one of the fastest growing verticals in
Facebook at the moment, so the healthcare business is
finding oxygen on the Facebook platform, she ex-
plained
The opportunity for people based marketing, at scale, is
enormous. Facebook is now home to over 1.95 billion
people. Messenger and WhatsApp now connect over
1.2 billion people around the world, and Instagram rev-
olutionises the way 700 million people capture and
share the worlds moments.
Facebook is also innovating against its mission and
wants to build technology that helps the blind commu-
nity experience Facebook the same way as others do.
Building a digital world consumers can
trust
Ilaria Passarani, Head of the Food and Health Depart-
ment, European Consumer Organisation (BEUC), which
promotes consumer interests, explained that more than
40% of consumers say that information found via Social
Media affects the way they deal with their health.
Consumers continue to have concerns around the secu-
rity of online data, yet, more than ever they are trusting
health information shared on social networks, she ex-
plained. 18 to 24-year-olds are more than twice as like-
ly than 45 to 54-year-olds to use Social Media for health
-related discussions.
90% of respondents from 18 to 24 years of age said
they would trust medical information shared by others
on their Social Media networks she went on to explain.
26
 Conference report

She cited some interesting statistics which found that Increased access to information in many formats, she
19% of smartphone owners have at least one health insisted, must be exploited for the benefit of public
app on their phone, with exercise, diet, and weight health.
apps being the most popular types. 28% of health-
related conversations on Facebook are supporting
health-related causes, followed by 27% of people com-
menting [on] health experiences or updates, she ex-
plained.

However, she pointed out that 74% of people world-

wide are worried about how companies use their infor-
mation. Only a third of respondents usually read the
terms and conditions, and two-thirds of respondents are
concerned about not having complete control over the
information they provide online. Nearly two-thirds of
respondents say that they do not trust online businesses
to protect their personal information, with more than a
quarter saying that they do not trust them at all.

Privacy and data protection were the biggest concerns

when it came to using digital in the healthcare sector,
she said, but if these issues were solved, consumers Ilaria Passarani
would benefit considerably.

How Regulation Helps Self-Care to Develop

The development of self-care remains strongly influ-
enced by the legal and regulatory framework. An up-
date was provided on the most relevant changes in the
area of food and non-prescription medicines, referenc-
ing AESGPs priorities.
Christa Wirthumer-Hoche, Chair of Management
Board of the European Medicines Agency (EMA), and
Head of the Austrian Medicines and Medical Devices
Agency (AGES MEA) opened the session by describing
an Austrian national provision which provided for a sim-
plified registration procedure for traditional herbal
medicines. With the European Union (EU) legislation on
traditional herbal medicinal products adopted in 2004,
out of around 300 herbals, only 10% submitted dossiers
according to the new legislation, 20% migrated to the
food sector and some to medical devices and cosmetics.
The registration for traditional herbal is expensive,
analysis is expensive and there are demanding require-
ments for quality, which encourages a move into the
food supplements sector, she said.

Some discussion is ongoing as to whether the scope

for traditional herbal medicines will be enlarged to in-
clude vitamins and minerals, she added.

Wirthumer-Hoche explained that the availability of non-

prescription medicines is high on the agenda of the EU
Christa Wirthumer-Hoche Medicines Agencies Network Strategy to 2020, and ap-
preciated that AESGP stands for the adoption of a bal-

27
anced regulatory framework, and that the framework
has to facilitate innovation and rapid market access, in a
harmonised way across Europe.
Developments in food safety and REFIT
Sabine Jlicher, Director of Food and Feed Innovation,
Directorate General Health and Food Safety, European
Commission, gave an outline of developments in the
food legislation, particularly relevant to consumer
healthcare industry.
Sabine Jlicher
She began by describing some developments in the
area of food safety and explained that with food crises
which have occurred related to BSE and Dioxin in the
late 1990s, it is very easy for consumers to lose trust.
Today we have the most stringent system for the man-
agement of food risks in the world. By that we are bet-
ter placed today to deal with food crisis, but it is still
important to remain alert. The European Commission is
currently conducting a so-called REFIT exercise on the
General Food law to see whether it is still fit for purpose,
and to find out whether there is anything that can and
should be improved. Instead of rushing to add on to the
regulatory framework without evaluating, it will first be
checked if it works and if there is an added value for the
EU.
Peoples expectations have changed. They expect their
food to be not just safe but nutritious and to be pro-
duced in a sustainable manner. This has called for EU
nutrition polices. In December 2016, the introduction of
mandatory nutrition labelling was finalised. The regula-
tion on nutrition and health claims sets the legal frame-
work for food businesses wishing to highlight beneficial
properties of their products, and to enable customers to
make healthier choices. She explained that a REFIT eval-
uation is currently being undertaken on this regulation,
and is expected to be completed in 2018. The outcome
will help the Commission to take an informed decision
on health claims for botanicals and whether there is a
need to harmonise the use of botanicals in the EU. The
final report of an external study on this is expected end
of September 2017.
She then moved on to talk about reformulation of pro-
cessed foods a voluntary initiative, to reduce levels of
saturated fat and sugars in the diet. It is an example of
where the European Commission is co-operating with
manufacturers and also member states authorities in
terms of monitoring systems. In health and nutrition,
through voluntary initiatives a lot can be achieved, and
the Commission believes there is room for a dual ap-
proach (regulatory and voluntary).
In the current environment, the main challenge, she de-
scribed is empowering consumers while leaving
enough flexibility to allow for innovation in the food
industry and safeguard the functioning of the internal
market. The aspiration for a more expansive food poli-
cy is not matched by a public appetite for food related
innovation. Risk aversion is prevalent in the food sec-
tor, e.g. in relation to Genetically Modified Organisms
(GMOs) and food additives which is getter bigger and
finding its way into public discussion. There is a reluc-
tance to embrace new approaches which clashes with
the need for food systems to evolve.
We need to address the mistrust, hostility, science and
evidence-based decisions she said which is becoming
increasingly difficult.
Jlicher concluded by saying that the European Com-
mission recognises that consumers increasingly take
responsibility for their own health, and will support con-
sumers in a transparent way, by ensuring that food is
safe and food information is not misleading. This frame-
work contributes to fair competition between food op-
erators, but also ensures that the limited budget of
consumers goes toward products that work. She also
added that the objective of the Commission is to take a
forward-looking approach to innovation in food pro-
duction. She reflected on earlier discussions and that
the Commission must also address the erosion of trust
in a transparent manner.
28

Hubertus Cranz, Director General of AESGP, gave his
perspective on the discussions from an AESGP point of
view, by explaining that AESGP sees itself as an evidence
based industry. Reflecting on the discussions about
trust, it was pointed out that the worst thing that can
happen to your business is losing trust. And evidence
base goes hand in hand with trust. On the right imple-
mentation of rules, he also noted that self-regulation
matters but needs to be based on a proper legal basis.
In his view, overall the legal basis is adequate, but suffi-
cient resources are important for the implementation
and supervision process.
On botanical claims, he explained that the process has
been long. He remarked that although non- action may
seem sometimes like the easiest political solution, it can
have important market implications.
Challenges in EFSA
Bernhard Url, Executive Director, European Food Safety
Authority (EFSA), described the role of EFSA and chal-
lenges they meet. Risk management and risk assess-
ment are separated in Europe stringently he said. The
latter is outsourced to EFSA in Parma while the former is
the responsibility of the European Commission. EFSA is
a small organisation of 450 staff persons, which mobilis-
es 1000-2000 experts on a voluntary basis (but they are
not employed by EFSA) for a three-year mandate to
conduct risk assessments in the food and feed chain.
There is still a long way to go to achieve globalised risk
assessments in the food and feed chain (although EFSA
is working on this), he informed.
Bernhard Url
29
Conference report
On health claims, he acknowledged that the botanical
health claims are still on hold. He also noted that the
EFSA guidance document needs updating to develop
clear criteria on the substantiation of health claims. Two
guidance documents were updated in 2016, and in 2017
guidance on the preparation and presentation of health
claims was published. EFSA has also set up a catalogue
of services to applicants and has introduced an SME
office in a pilot phase to support industry when prepar-
ing and submitting health claims.
Scientific challenges that EFSA faces include endocrine
active substances, antimicrobial resistance and the sur-
vival of beehives. EFSA also faces challenges in sourcing
expertise on issues related to transparency and the in-
dependence of its experts (which he notes is made diffi-
cult as the European research policy, Horizon 2020, forc-
es universities to collaborate with industry).
EFSA has set up a complex system of managing expert
interests to assess conflicts of interest, which can be
burdensome. Finding independent experts, he said, may
be more challenging for EFSA than the EMA. He also
commented that in the food industry there is a high
benchmark for experts as there is a high expectation for
quality in the sector - and EFSA do not pay for experts.
We need to find new models of reimbursing these ex-
perts/their organisations. EMA has double the staff and
four times the budget, which EFSA looks on with envy
as it relies on volunteers.
The second challenge is transparency which goes back
to trust. Trust depends on competence (for EFSA scien-
tific competence and opening itself to scrutiny) and
character (being transparent so that its activities could
be replicated). However, industry data cannot be made
public as this would infringe on intellectual property
rights and trade secrets. There is no legal framework in
place to make raw data available to academia for scien-
tific scrutiny. However, he commented that if EFSA
could move in a regulated approach towards this, it
would help regain trust in the industry.
EFSA also faces specific challenges when science meets
values/policy. If EFSA comes out with a scientific opin-
ion that supports the political agenda of a group, EFSA
is praised he remarked. He gives the example of EF-
SAs opinion which established the risk of nicotinates to
bees which the European Commission supported, and
was therefore well received.
He concluded by saying that it is no longer enough to
do good science. You have to engage with the civil so-
ciety, (and build trust) to come up with a co-evolution of
science which is a challenge for EFSA in the years to
come.
Hubertus Cranz, Director General of AESGP, gave his
perspective on the discussions from an AESGP point of
view. He expressed his appreciation of EFSAs efforts in
the improvement of services, such as the help desk. He
also stated AESGPs belief that a closer interaction be-
tween applicants and scientists (panelists in EFSAs case)
can improve decision making, and the output of scien-
tific evaluations. That the pharmacovigilance system is
covered by fees, while nothing is paid into EFSA, is a
discrepancy in the system which is not easy to explain,
he stated. AESGP disagrees with fees as a pure financing
instrument. However, he acknowledged that fees may
be acceptable if services can be improved by a well-
organised and transparent interaction between appli-
cants and panel members.
Regulatory optimisation and self-care in a
changing Europe
Regulators are making efforts to optimise regulatory
operations and ensure greater access to non-
prescription medicines, according to Zade Frias, Head
of Human Medicines Evaluation Division, European
Medicines Agency (EMA).
Zade Frias
She presented two initiatives, which she said addresses
half of AESGPs 2020 goals. The first initiative is on the
Regulatory Optimisation Group (ROG), chaired by Stan
Van Belkum from the Dutch Medicines Evaluation Board
and co-chaired by herself, which will formally kick off on
14 June. For the first time, it brings regulators and in-
dustry together to review existing regulatory proce-
dures. The group also brings business and IT together to
leverage the advantage of technology and develop
common ICT platforms. The ultimate goal is to identify
value added data that could be captured in a structured
way to support product life cycle maintenance and deci-
sion making.
She explained that a challenge for the ROG is that it is
quasi impossible to track the product history over its
entire lifecycle in the European environment, referring
to pantoprazole, which was switched to non-
prescription status throughout the European Union by a
centralised procedure, but had originally undergone
decentralised authorisations. She also noted that sub-
mission formats have also changed from paper to elec-
tronic documents and will continue to evolve into more
structured data and emerging international regulations/
standards (ISO IDMP).
There is a significant cost linked to send/receive, vali-
date, maintain and distribute Marketing Authorisation
Application data. The idea is to reduce regulatory bur-
den for applicants and regulators, saving administrative
and scientific resources for the more valuable areas of
the regulatory work.
The first target of the ROG would be Type IA variations
and it would be presenting its first business case for
handling such variations to the Heads of Medicines
Agencies (HMA) in September.
She also reminded the audience about the joint multi-
stakeholder initiative of the EMA and the Co-ordination
committee for the Mutual-recognition and Decentral-
ised procedures - human (CMDh) in the area of scientific
advice procedures for OTC medicines an initiative co-
sponsored by herself and Peter Bachmann as chair of
the CMDh. It targets timely access to non-prescription
medicines and reinforces the regulatory capacity and
capability of the network. Its first stakeholder workshop
would be held in the third quarter of 2017, she said, to
discuss the composition and function of the OTC Expert
Forum that would be led by the CMDh.
30
 Conference report

The aim is to build on an early interaction with Appli-
cants/Marketing Authorisation Holders (MAHs) and
stakeholders on relevant aspects of OTC switch for Na-
tional/Mutual Recognition Procedures/ Decentralised
Procedure and Centralised Procedure and create plat-
form for exchange on factors that influence decisions on
switching, beyond the scientific balance of benefits and
risks, and bring relevant stakeholders including experts
from national switching bodies, healthcare professionals
and patients around the table.
This workshop would be organised, against a backdrop
of every second medicine in the European Union being
non-prescription, yet only four medicines had been
switched through the EUs centralised procedure in 10
years, and only five medicines were available in every EU
member state.
Hubertus Cranz, AESGP Director General commended
on the initiatives from an AESGP perspective. He ex-
plained that it is fully in line with the associations
Agenda 2020, launched at its 52nd Annual Meeting in
Athens a year ago. We are ambitious but honestly we
didnt expect such success within the first 12 months
after launch of the agenda, he remarked.
Putting greater access to non-prescription medicines on
the regulatory agenda, reducing regulatory burden
through the ROG and involving multiple stakeholders in
a non-prescription scientific advice procedure are all top
issues for the self-care industry. AESGP will continue to
contribute to the discussions and looks forward to see-
ing the results.

She explained that there are two parallel switching

worlds in Europe. At EMA there are first in class switches
of the centralised product or innovative (switch by de-
sign) switches with ultimately a harmonised legal status.
Switches at National/CMDh level which effectively drives
most switches at EU level but do not result in a harmo-
nised legal status in the end. The idea would then be to
bring the best of both of these worlds to debate the
full spectrum of switches. It would also provide a forum
to exchange real world experience and the perception
of risks. The aim is to use a well-established EMA scien-
tific advice procedure. A CMDh led expert group would
advise the scientific advice group on whether there is an
interest to invest in the switch. Such a group would also
be able to engage with further stakeholders. It remains
to be decided who these stakeholders might be.
Hubertus Cranz

31
Challenges Ahead
Medical Devices Regulation Regulatory
framework and challenges ahead
Gesine Meissner
Gesine Meissner, Member of the European Parliament
(MEP) and Shadow Rapporteur for the new Medical De-
vices Regulation (MDR) and In-Vitro Diagnostics Regu-
Transitional provisions under Article 120.4 allowing the devices to stay on the market or under
Article 120.3 to be placed on the market after the date of application under certain conditions
lation (IVDR) for her political group and, by that, closely
involved in the negotiation process, began her presen-
tation by giving an overview of the adoption process of
the new regulations. Agreement in the so-called Trilos
was reached on 25 May 2016. The formal adoption by
the European Parliament and Council took place on 5
April 2017. The MDR entered into force on 25 May 2017
and is applicable from 26 May 2020.
As a co-legislator, the European Parliaments involve-
ment is limited from now on, but the work between the
Member States, the European Commission and the
stakeholders has just begun. In 2020 manufacturers and
notified bodies must be ready to apply the new rules
and the EUDAMED database must be functional. Politi-
cal core issues during the negotiations included the
reprocessing of single use devices, the scrutiny proce-
dure, CMRs, Aesthetic Devices, liability, traceability,
the Implant Card, classification rules on nanomaterials
(Rule 19), and substance-based medical devices (Rule
21) and more recently unannounced audits. As a mem-
ber of the Liberal party (Group of the Alliance of Liber-
als and Democrats for Europe), Mrs Meissner was di-
rectly involved in the debate on Rule 21 which was not
previously the focus of discussions in the Parliament.
32
 Conference report

Mrs Meissner updated on the outcome of the debate on
Rule 19 concerning nanomaterials. The Council position
was that the text should read can be released vs.
intended to be released, the latter being the European
Parliament position. It was finally agreed that for nano-
materials a classification according to the risk of expo-
sure would be defined in the implementing acts. The
European Commission, who is in charge of the imple-
menting acts, should now define based on scientific
knowledge and latest findings, what high, medium or
low risk means. On Rule 21 concerning substance-based
devices, the Parliament managed to move the position
from a complete ban/ complete up classification to all
Class III to an agreement on the classification according
to absorption level and intended purpose.
medical device from a medicinal product. It is therefore
critical to have proper definitions of pharmacological,
immunological and metabolic means.
She also gave an overview of the transitional arrange-
ments in place. All devices placed on the market pursu-
ant to the Directives can continue to be made available
on the market or put into service until 27 May 2025 if
certain requirements are met. Certificates will become
void on 27 May 2024. However, there are many new
requirements related to an up-classification to Class III
(including new clinical investigations). Accordingly,
manufacturers of substance-based medical devices re-
classified in Class III will face potentially expensive new
requirements.

According to Mrs Meissner, for the implementation In light of this, the transitional period in Article 120
phase of the MDR and, in particular, Rule 21, the con- should be implemented adequately and uniformly to
cept of a risk-based approach shall be maintained dur- provide sufficient time for industry and notified bodies
ing the implementation process. The classification must to ensure availability of substance-based medical devic-
always be justified by the intended purpose and the es.
inherent risk. This is key for a proportionate implemen-
tation approach. We should define a broad under- Challenges the Notified Bodies
standing of low risk. In her opinion, substances with a
long history of safe use (e.g. foodstuffs) should be con-
Roberta Marcoaldi, Director of Notified Bodies Istituto
sidered as low risk. She also highlights the need for
Superiore di Sanit (ISS), Italy, gave her perspective on
clear guidance on what systemic absorption is, which
the implications of the new MDR from a Notified Body
she trusts the European Commission will implement in
perspective. Since 1996, the Notified Body 0373 works
consultation with stakeholders to achieve a common
in the field of medical devices in according to European
understanding.
Directive 93/42/EEC. The Notified Body 0373 has been
designated for CE Certification for Class III devices. Since
She explained that in general, experience from the Hel-
2009, Notified Body 0373 also works in the field of in
sinki Procedure, has shown that insufficient involvement
vitro diagnostic medical devices in according to Europe-
of manufacturers and notified bodies result in unsatis-
an Directive 98/79/EC.
factory outcomes. It should, therefore, be ensured that
notified bodies and concerned manufacturers are
properly involved and systematically informed at an ear-
ly stage of the procedure.

Stressing the importance of scientific advice, she calls

for a clarification on the consultative role of EMA, EFSA
and ECHA. She also calls for data on a category of prod-
ucts published on the Commission website prior to the
launch of the examination procedure. This would not
only allow a fair and transparent start of the procedure
but also guarantee that the views of all concerned man-
ufacturers and notified bodies are fully taken into con-
sideration by the committee which delivers an opinion
when considering the classification of a specific product
or category of products.

In her view, the principal mode of action of the product

is a key determinant when it comes to differentiating a Roberta Marcoaldi

33
In the last years, the Istituto Superiore di Sanit has de-
veloped a specific know-how on the evaluation of sub-
stance-based medical devices. In her view, substance-
based medical devices represent a great opportunity for
the healthcare sector.
In the case of substance-based medical devices, the
close correlation between medical devices and medici-
nal products also needs to be considered.
The definitions of medical device and medicinal prod-
ucts are, from her perspective, overlapping. Both can
have same intended use (treatment or prevention of
diseases) but do have different mechanism of action by
which they reach their effect. The terms therapeutic
effect and mechanism of action are not used consist-
ently, which complicates the situation. A definition of
different mechanisms of action is still lacking.
This is one of the reasons for the increasing number of
products that are on the borderline between medical
devices and medicinal products. However, at the end a
case by case approach and assessment are necessary.
MDR requirements define also a more stringent ap-
proach to assess such medical devices, which represent
a new challenge for manufacturers and Notified Bodies.
The MDR established the category of substance-based
products and defines a special classification rule: The
Rule 21. As a result, substance-based medical devices
will no longer be classified as Class I. This will mean an
increasing number of medical devices requiring the
evaluation of a Notified Body.
Rule 21 introduced the concept of substance absorp-
tion. It will, therefore, be necessary to define a correct
interpretation of Rule 21 and understand the term
absorption of substances. The absorption of substanc-
es can determine the different classification of medical
devices. This will determine the kind of documentary
evidence in the product technical dossier with Annex II,
which manufacturers have to provide.
Mrs Marcoaldi expressed the wish that a close collabo-
ration between Notified Bodies and manufacturers is
established during the implementation process of the
new regulation.
Engaging patients / consumers emotionally
to build powerful brand relationships
Ralph Ahrbeck, Founder and CEO, Arqus Advisory,
concluded the session with examples of some success-
ful companies that have leveraged an intimate under-
standing of their consumer to further develop self-care.
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 Conference report

Ralph Ahrbeck Bernard Mauritz

Understanding what consumers think, their attitudes
and values, he says is vitally important today. Trust in
brands is an intangible asset and is at all time low.
Trust in a brand increases compliance/product use and
results in better patient outcomes. Trust in OTC brands
reduces visits of General Practitioners for minor ailments
and reduces the burden on the healthcare system. How-
ever, he points out that typically, advertising is all about
preaching product benefits to consumers; what the
problem is and what is the solution. He stresses that we
must speak differently to our consumers. Todays em-
powered consumers want us to engage them, under-
stand their needs/wants, go beyond functional and es-
tablish an emotional bond. A brand is the combination
of tangibles and intangibles a mix of product, service,
images, associations, people and visual statements that
create a certain perception.
Empowered consumers want companies to take a stand,
have a point-of-view, be modern and relevant.

Invitation to Amsterdam 2018

At the end of the conference, Bernard Mauritz, Executive Director, Neprofarm, invited all participants as well as all
those interested in the latest developments on self-care around the world to the 54th AESGP Annual Meeting, which
will take place in Amsterdam from 5-7 June 2018. The program will be available by the end of this year.

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