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Annual Meeting
Amsterdam, 5 – 7 June 2018
Conference Report
The 54th AESGP Annual Meeting – the annual gathering of the self-care sector in Europe – was held in Amster-
dam, the Netherlands, from 5 to 7 June 2018. The conference entitled “Connecting the smart consumer”
looked at the evolving self-care market place, addressing challenges related to digital space and e-commerce,
and how to best serve the expectations of the newly informed consumer.
In the opening session, attention was paid to the chal- neither a sufficient reward nor an incentive for innova-
lenges governments are today facing to provide quality tive switches. The role of brands and branded infor-
and accessible healthcare to citizens in Europe and mation in helping people make informed decisions was
across the world. The role of self-care and consumer highlighted.
empowerment in providing solutions and further im-
proving the sustainability of healthcare systems was Dr Jacques de Haller, President of the Standing Com-
explored. mittee of European Doctors (CPME), confirmed support
of doctors to self-care and the important role it plays in
Speakers from the industry Birgit Schuhbauer, AESGP healthcare systems. Referring to the results of the EU
President, Tamara Rogers, Senior Vice-President and funded PiSCE Project on which AESGP and CPME
Region Head for Europe, Middle East and Africa at GSK worked together, De Haller noted that patient educa-
Consumer Healthcare, and Heather Bresch, CEO of tion should be at the heart of the self-care policy in or-
Mylan, presented the contribution and potential of the der to realise a full potential of self-care, starting early
self-care industry in helping resolve these challenges on in schools.
and stressed the need for innovative solutions. Encour-
aging self-care and empowering individuals to take re-
sponsibility for their health and bear the cost of some
interventions aimed at preventing ill health or treating
suitable conditions is an obvious response to many of
the problems modern healthcare systems come across
nowadays. Non-prescription medicinal products are the
most frequently used healthcare intervention, benefiting
millions of Europeans every day. However, the industry
is worried about the fact that the number of active in-
gredients available without prescription is stagnant.
Back-switches also always remain a threat. Access to
products for the most recurring conditions should be
improved by switching them to non-prescription status,
thereby freeing time for healthcare professionals, and
more should be done to prevent back-switches. It was
observed that the short data protection of one year is
1
Antimicrobial resistance (AMR) is
a major threat in the modern
healthcare delivery said Filipe
Froes, Member of the Commit-
tee of the Portuguese Ministry of
Health for national guidelines on
antimicrobial resistance, preven-
tion and control infection. Res-
piratory tract infections, such as
common cold, are one of the
major reasons for the trivial use
of antibiotics; what is more criti-
cal is that antibiotics are inap-
propriately prescribed for viral
infections in more than half of
the consultations. The self-care
industry, and in particular cough
and cold products, play an im-
portant role in tackling antimi- From left to right: Heather Bresch, Filipe Froes, Tamara Rogers, Birgit Schuhbauer, Cathy Smith
(moderator) and Jacques de Haller
crobial resistance through dis-
couraging the inappropriate use
of antibiotics and providing effective solutions to man- solutions, such as wearable technology and mHealth
age cold and flu symptoms. Empowerment, literacy and apps, citizens can actively engage in health promotion
trust are key to the fight against AMR and self-care has and self-management of long-term conditions. This in
a role to play. turn can help control the rising demand for health and
care. Digital tools hold great potential to disseminate
All speakers acknowledged that consumers are in favour scientific knowledge and information in an easily acces-
of a greater availability of self-care products, but should sible form, so as to help people stay in good health –
be properly informed and supported. By using digital thus preventing them from turning into patients.
2
healthcare. Examples of products associated with per- connected consumer. In order to succeed, it must create
sonalised services / chatbots working thanks to artificial partnerships with both traditional and ‘new’ stakehold-
intelligence were given. ers. The consumer health industry is a trusted and re-
sponsible partner that needs to further engage with
All speakers agreed that the industry should have a co- regulators in developing an appropriate framework to
ordinated approach to the challenges of the changing ensure access to data for the public benefit and to gain
market place and invest in better understanding of the further insights in consumer needs.
3
Uwe May, researcher at May and Bauer, pre-
sented the results from a study conducted on
behalf of IGEPHA, the Austrian Self-Care As-
sociation. The study aimed at identifying op-
portunities for innovative switches and at
providing some recommendations for deci-
sion makers. A methodology to identify and
prioritise potential switches was also devised
by the researchers. May underlined the eco-
nomic benefits of switching: EUR 5.20 saved
for every euro invested and 1.9 hour per day
and per GP is saved! The risk of not switching
needs to be taken into account. What will the
consumer/patient do? Turn to an alternative
product available OTC? Take nothing? Go to
the GP? All these alternatives may have an
impact on the consumer’s/patient’s health.
Self-care and switching need to be discussed
at societal level, as data show there is a great
potential.
The session highlighted the need to build national self- A shift from being product to citizen centric is needed,
care policy supporting citizen empowerment and ensure providing citizens with personalised solutions. In order
an adequate political support through a proactive advo- to realise the full potential of self-care, consumers need
cacy. It is essential to set up a positive environment for to have access to quality information; health literacy is
the industry and improve the public’s perception of self- key to promoting self-care. National studies show a lack
care by showing that it can significantly contribute to of knowledge not only in relation to one’s own health
the sustainability of healthcare systems in Europe. Fabio and health condition, but also to the healthcare system
Mazzotta, Vice-President of ASSOSALUTE and General and regulatory framework. Much more still needs to be
Manager, Italy & Malta Sanofi Consumer Healthcare, done in countries such as Russia as was presented by
showed clear benefits of self-care to an overburdened Vera Suldenko, Public and Government Affairs Advisor
Italian healthcare system. However, as pointed out by at Bayer Russia, where a clear information and educa-
Traugott Ullrich, Vice-President, BAH, the German tion gap with regard to self-care still exists, not only
Medicines Manufacturers Association and General Man- among citizens but also among healthcare practitioners.
ager at Schwabe Pharmaceuticals, the self-care industry In filling this gap, industry can follow the example of
has often not been seen as a credible promoter for the recent success stories such as in Greece, as highlighted
improvement of public health. by Aggelos Tsakanikas from the Greek Foundation for
From left to right: Aggelos Tsakanikas, Vera Suldenko, Fabio Mazzotta and Traugott Ullrich
4
Economic Industrial Research. Significant progress was duction of semi-free pricing and overall improved per-
achieved in the last years with non-prescription medici- ception of the industry.
nal products no longer being reimbursed and the intro-
5
Artificial Intelligence: A Game Changer?
From left to right: Kenton White, Lisa Latts and Adrian David Cheok
6
Consumer Health Products Regulation: An Update
Session 7 provided an
updated overview of the
regulatory develop-
ments in the consumer
health area in the EU.
Marcel Van Raaij, from
the Dutch Ministry of
Health, presented the
ongoing progress on the
relocation of the EMA
from London to Amster-
dam as a consequence
of Brexit, stressing the
importance of business
continuity and the op-
portunities the move
offers to the Nether-
lands. He further gave
an overview of the im-
plementation of the new
Medical Device Regula-
tion, both at national
and European level, not-
ing some of the chal-
lenges still to be ad- From left to right: June Raine, Bernard Mauritz (moderator), Alexandra Nikolakopoulou and Marcel Van Raaij
dressed, notably the
availability of notified bodies, the setting up of Eu- via a QR code on the packs and the Dutch pharma-
damed, the consequences of Brexit for all actors of the covigilance centre Lareb which has an application to
system as well as the availability of expertise. He report adverse reactions. She reminded that the 5-year-
acknowledged the importance of stakeholder involve- old Tajani initiative, which resulted in the “Good govern-
ment in the implementation process. ance for non-prescription medicines” recommendations,
continues to be implemented and to have a positive
June Raine, Chair of the Pharmacovigilance Risk Assess- impact in the UK.
ment Committee (PRAC) at the EMA, presented the
main achievements of the PRAC with a particular focus Alexandra Nikolakopoulou, Head of the ‘Food Infor-
on lessons learnt since its establishment in 2013. Agree- mation and Composition, Food Waste’ Unit of the Euro-
ing with AESGP’s prior suggestion, she underlined that pean Commission, gave an overview of the regulatory
referrals for well-established substances have decreased developments in the area of food supplements. She
and have been replaced by a more appropriate handling noted that it is a highly regulated area, although some
of those issues via Periodic Safety Update Reports. She issues are yet to be regulated. Regarding the specific
also touched upon the digitalisation of pharmacovigi- directive on food supplements, maximum levels of vita-
lance, giving examples of a product’s survey accessible mins and minerals still need to be set. Referring to the
Regulation on fortified foods, specifically the Article 8
procedure for “other substances”, the ongoing proce-
dures for three plant substances – hydroxyanthracene
derivatives (HAD), green tea catechins and monacolin K
– were noted. Following the EFSA opinion on HAD, the
decision on risk management is to be adopted by the
end of the year in light of the many challenges related
to the opinion. With regard to botanicals, there has
been a substantial delay of the re-evaluation process of
the legislation. Nikolakopoulou also provided an update
on the ongoing REFIT evaluation of the Nutrition and
Health Claims Regulation, notably with regard to botan-
icals, indicating that the results of the evaluation were
now expected for the end of 2018. Last but not least,
she presented the key changes to the General Food Law
included in the Commission’s proposal on transparency
and sustainability of the EU risk assessment.
7
AESGP in Transition: The Future of Self-Care
The closing event in the Winter Garden of the NH Krasnapolsky was the occasion to pay tribute to Hubertus Cranz for his 30 years of leadership
8
Conclusions
The two-days discussions on the future challenges for There are opportunities for innovative switches, which
the self-care industry in Europe were marked by a few would bring clear benefits for all involved.
main concepts and ideas, and opportunities for the in-
dustry to expand its role and promote self-care were Digitalisation can be noted as an overarching topic, yet
identified. with specific challenges which remain to be addressed
at the legal and regulatory level, focusing primarily on
The self-care industry can make a significant contribu- big data and access to data, the increasing relevance of
tion to the healthcare systems in Europe as shown by e-commerce and the connected consumer.
different case studies from across Europe. Initiatives
promoted by national associations have been an effec- In line with the title of the conference, the digitally em-
tive way of creating a positive environment also by im- powered consumer was at the heart of the debates.
proving public perception of self-care. Connected consumers need to be put at the centre and
be offered holistic solutions so that they can become
Switching medicines from prescription to non- full actors of their own health and engage further in
prescription status should be encouraged as a path to prevention. The industry should be active and ready to
success, taking into account enablers, such as unmet respond to the changing needs.
needs, market readiness and stakeholder engagement.
At the end of the conference, Martin Bangerter, Director of the Association of the Swiss Self-Medication Industry
(ASSGP), invited all participants as well as those interested in the latest developments on self-care around the world
to the 55th AESGP Annual Meeting, which will take place in Geneva from 4 to 6 June 2019.