51st AESGP Annual Meeting

Barcelona, Spain | 26-28 May 2015

Citizen empowerment:
A megatrend of the 21st century

Conference report

Citizen
empowerment:
A megatrend of the 21st century
was the central theme of the 51st
AESGP Annual Meeting which
took place in Barcelona from 26
to 28 May 2015. The meeting
gathered nearly 500 participants
from 42 countries, including
representatives of the European
and national governments and
regulatory authorities, media, the
umbrella organisations of health
professionals, consumers/patients,
as well as the consumer health
industry.

The opening event at Casa Llotja de Mar

The event in Casa Llotja de Mar

more available to the consumers.

was opened by Boi Ruiz, Minister

"We need to empower citizens in

of Health of Catalonia, who wel-

health care through new technolo-

comed the participants in the

gies, said Jordi Ramentol, Presi-

capital of his region and empha-

dent of the Spanish Association of

sised the importance of self-care

the Self-Medication Industry anefp

for the health care systems and

and CEO of Ferrer. He expressed

citizen empowerment. This was

appreciation of the progress made

echoed by Agustin Rivero, Direc-

in Spain on the promotion of self-

tor General of the Spanish Ministry

care and stressed a need for conti-

of Health, who highlighted the

nuous cooperation between the

efforts of the Spanish government

authorities and the industry.

to promote self-care and make it

Opening remarks of Boi Ruiz, Agustin Rivero and Jordi Ramentol

1

Consumer Health Industry: how to provide the best service?

The messages of the opening evening were followed up by Pedro Nueno, Professor in the Department of Entrepreneurship at IESE Business
School and Professor and President at CEIBS
(Shanghai, Beijing). The increase in the life expectancy of modern society is causing major and unaffordable health costs, said Nueno. By that the importance of the self-care sector is getting more and
more recognised and the cost savings are well documented.

Pedro Nueno

Global perspectives on Citizen Empowerment

Roger Scarlett-Smith, AESGP President and Head of Global Categories at
GSK Consumer Healthcare, shared his enthusiasm about the direction that
self-care is taking and expressed hopes that a more positive business climate can be created which will lead the long-term improvements of consumer empowerment. To make real progress for self-care and consumer empowerment, trust and collaboration between industry and policy makers are
needed, said Scarlett-Smith. The self-care sector needs a balanced policy
framework which would combine mandatory and voluntary measures that
expand consumer access, preserve information to consumers, protect privacy and maintain consumer safety, at the same time allowing room for innovation.

Roger Scarlett-Smith

An overview of the OTC market trends, also in the context of consumer empowerment was presented by Andy Tisman, Senior Principal Consumer
Health at IMS Health. The global OTC market increased by 4,8% in 2014.
Particularly impressive was the increase in Latin America, but also South
Asia and the Middle East benefitted from the positive economic climate.
Less positive was the development in North America and Japan. Central and
Eastern Europe did again better than Western Europe.

Andy Tisman

Tisman noted that different industry sectors not only

pharma but also fast-moving consumer goods (FMCG)
companies are moving into consumer health and
wellness products. This shift of focus has led to new
transversal market segments of cosmeceuticals, nutraceuticals and nutricosmetics, attracting new competitors. The consumer empowerment is a major trend
and will be a key driver for growth in the future, concluded Tisman.

Meeting report

We have a highly regulated European framework

longer in line with information society and the intel-

which protects us and it will not be appropriate to

lectual property rights are insufficient for the work

leave it away, urged Dagmar Roth-Behrendt, a

done in the area of innovation with well-known subs-

former Member of the European Parliament, com-

tances. Innovation needs to be made easier through

menting on the new Better Regulation initiative of the

well-functioning centralised and national procedures,

new European Commission. Roth-Behrendt said that

including the move of medicines from prescription to

better regulation efforts are supported if they aim for

non-prescription status.

a good overall balance. Not every lifting of rules is

leading to better regulation. She called for a cautious
approach when it comes to ideas to change of legislation as the outcome in the current political constellation is very uncertain. In addition, the legislation in
place is often not so bad but the problem is with its
implementation.
Marketing authorisation and variation procedure for
medicines with well-established substances are certainly too complex. Communication rules are often no
Dagmar Roth-Behrendt

New technologynew guidancebetter self-care

Brian McNamara

Today, new technology is key to drive the consumer empowerment, pointed out Brian McNamara, Region
Head Europe and Americas at GSK Consumer Healthcare. This creates unprecedented opportunities for the
consumer health care industry. The companies with innovation potential will have the most to gain.
We therefore need to continue investing in innovation, called McNamara on the conference delegates.
Current trends in digital health were presented by Ryan
Olohan, Industry Director Healthcare at Google. He gave
numerous examples of self-care electronic devices and
smartphone applications used for monitoring and support for diagnosis as well as online networks, social channels and health related videos for consumers and patients. Olohan also revealed that 1 in 20 Google queries equivalent to 3.5 billion searches everyday - is health care
related which indicates a growing patient and consumer
empowerment.
Ryan Olohan
3

Among the top search categories are headache,

indigestion, skincare and allergies. Google also
recognises that a major global trend is internet
access from mobile devices, including new internet users.

Ashley van Heteren

A large number of digital health startups are emerging into the healthcare sector while classic pharma and
med tech players respond slowly to this trend, said Ashley van Heteren, Associate Partner at McKinsey&Company. Companies must address many questions related to digital healthcare in order to really benefit
from technological innovations and to make them useful for consumer empowerment.

By 2020, 75% of all deaths and healthcare costs will result from chronic
diseases estimated Didier Deltort, Global Monitoring Solutions General Manager at General Electrics Healthcare Finland, who looked at global trends in health. An increased number of chronic diseases will influence the future of industry and is expected to drive structural
changes of healthcare, said Deltort. General Electrics Healthcare predicts that a shift from todays healthcare delivered in analog/paper way
to tomorrows digital/networked tools will enable real-time, continuous
information flow and comprehensive view of health and chronic disease
Didier Deltort

management, wellness and prevention.

Carlos Lens of the Ministry of Health in Spain,

highlighted recent measures of the Spanish government, taken in collaboration with the Spanish Association of the Self-Medication Industry
(anefp), to promote the self-care sector to ensure that citizens can practise self-care more responsibly. This included enhancement of prescription of non-reimbursed medicines by medical
professionals.

Carlos Lens
4

Meeting report

How to make health care affordable?

With the ageing populations, increasing disease
burden, and new treatment options, the global
healthcare costs become unaffordable. The role of
self-care in the sustainability of the healthcare systems becomes increasingly recognised by the national authorities, highlighted Jaume Pey, Director
General of the Spanish Association of SelfMedication Industry (anefp). He emphasised that
investing in self-care provides significant savings for
Jaume Pey

the national healthcare systems.

The economic impact of a hypothetical switch of a

medicine from prescription (Rx) to non-prescription
status (OTC) in Spain was analysed by Laura Pellis,
Senior Researcher Center for Research in Health and
Economics (CRES) at the University Pompeu Fabra
(UPF) in Barcelona. According to the CRES study, a
switch of 5% of prescription medicines used to treat
minor ailments to non-prescription status would generate total savings of over 3 million EUR for Spain
over 5 years.

Laura Pellis

These results show the positive impact of

self-care for the entire health care system
thanks to its contribution to increased
patients empowerment noted Pellis.
She concluded that the positive impact of
Rx-to-OTC switch from a societal point of
view

should

be

combined

with

in-

vestments in educational programmes on

patients self-care.

Health care professionals, including medical

doctors, play an important role in supporting
and promoting self-care. Integration of self-care
medicinal products in the Electronic Prescription
System REC@T in Catalonia was explained by
Toni Gilabert, Director of Pharmacy and Medicines at Catalonia Health Department.

Toni Gilabert
5

The advantages of the system are improved patients

safety in the context of avoiding medicines interactions, increased patients empowerment, promotion of
sustainability and rational use of medicines and facilitation of coordination and communication among the
health care professionals.

Harris Mylonas

Greece has one of the lowest percentage of pharmaceutical ingredients classified as OTC in the EU, said
Harris Mylonas of the National School of Public Health in Greece. He presented results of a case study on
the economic value of switching medicines from prescription to non-prescription status in Greece, which
showed significant benefits from a possible OTC list expansion, with overall savings for the national economy
summing up to 160 million EUR.

The new EU Platform for the

promotion of self-care
systems

PiSCE - the EU-funded pilot project on the promotion of self-care systems in the EU - was presented
by Rosa Suol, Director General in Avedis Donabedian Institute in Barcelona. The Avedis Institute
is one of the international organisations involved
in the PiSCE Consortium, along with the Dutch
Institute for Healthcare Improvement, the Danish
Committee for Health Education and the Standing
Committee of European Doctors (CPME). Suol
explained that the PiSCE project work on guidelines on the promotion of self-care and on actions
fostering collaboration on self-care at the EU level.
This included the creation of the PiSCE Platform of
25 European experts in different areas, including
policy makers, consumers and patients, healthcare

Rosa Suol

professionals, educators and researchers.

Meeting report

Birgit Beger

The doctors perspective on the promotion of self-care in the EU was given by Birgit Beger, Secretary General of the Standing Committee of European Doctors (CPME). Beger highlighted that in order to identify
the areas where self-care can and should be promoted, necessary evidence needs to be collected, to provide a common understanding of which minor or acute ailments or long-term conditions are manageable
through self-care.

Cristina Cabrita

Low health literacy is a barrier to self-care, highlighted Cristina Cabrita, Senior Project Officer at the Portuguese Consumer Organisation (DECO) speaking on behalf of the European Consumer Organisation (BEUC).
The results of the consumer organisations survey on self-management of chronic diseases carried out in
Belgium, Italy, Spain and Portugal show that around half of the consumers surveyed in these countries are
lacking skills when trying to find health-related information on the internet. One third expressed difficulties in
using simple information on drug administration and 40% of the consumers surveyed in Spain to nearly 70%
in Portugal do not feel at ease to ask health professionals to explain unclear issues about their health problems. Cabrita noted that these are the barriers to effective self-care which should be addressed by the PiSCE
project in order to create a more self-care friendly environment.
The new communication technologies have potential to provide citizens with truthful, relevant and
high quality information to enhance their self-care,
recognised Carmen Pea, President of the International Pharmacists Federation (FIP). Pea called on
doctors, pharmacists, patients and industry to
further cooperate and agree on how to enable the
European citizens access to responsible self-care.
Carmen Pea
7

The pharmaceutical industry works intensively to

provide relevant and accurate information to the citizens, summarised Jaume Pey, Director General of
the Spanish Association of the Self-Medication Industry (anefp). Pey illustrated this with the Spanish
self-regulatory assessment for advertising of nonprescription medicines which was developed by
anefp. Pey also said he was supportive of training
programmes for the pharmacists.
Jaume Pey, Rosa Suol, Birgit Beger, Cristina Cabrita and Carmen Pea

Self-care medical devices and food supplements:

New drivers for the self-care market?

Hubertus Cranz

The new comprehensive AESGP Databanks

The comprehensive AESGP Databanks system should be a

system on regulatory, legislative and market

most useful tool for companies to set market transparency

provisions on self-care products was official-

and is in line with the AESGP commitment to provide evi-

ly launched at the conference by Hubertus

dence as part of its political activities. Evolution of diffe-

Cranz, AESGP Director General. The new

rent regulatory environments of product categories in-

Databanks system includes the on-line

fluence and drive the self-care market, the conference

AESGP Med Databank on medicines with a

delegates heard. Medical devices and food supplements

new dedicated section on medical devices

are gaining an increasing role in self-care and by that they

and the new on-line AESGP Databank on

are getting a lot of attention both from the business as

food supplements.

well as from the regulatory communities.

The role of the European Food Safety Authority (EFSA)

for the food supplements industry was explained by
Valeriu Curtui, Head of the Nutrition Unit at EFSA, who
focused on the scientific evaluation process for health
claims and stressed that EFSA applies the highest standard of scientific evidence for all claims.
Valeriu Curtui
8

Meeting report

Dr Curtui also explained that EFSA is in charge of the

safety evaluation of food supplements ingredients as
well as processing aids such as food additives. He also
revealed that the EFSA Compendium of botanicals of
concern when used in food or food supplements will be
updated by the end of 2016.

Insights on the current revision of the medical devices legislation were shared by Gwenole Cozigou, Director of Internal Market,
Industry, Entrepreneurship and SMEs Directorate GROWTH at the European Commission. Cozigou said that the Commission
proposal for a new regulation on which the
European Parliament expressed a first reading position in 2014 is now being intensively discussed among the Member States
experts in the Council. One of the key issues
is the Rule 21 for substance based medical
devices. The Latvian Presidency of the

Gwenole Cozigou

Council is trying to enable agreement on a

compromise text by the end of its mandate in June 2015. The rapid adoption of the new regulations on medical devices is important to restore confidence in the EU regulatory system and to ensure competitiveness in
this industry sector concluded Cozigou.

In the given context, the audience appreciated an update on the European regulatory framework for herbal
medicinal products and the options for market access
were explained by Werner Knoess, Chair of the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA). Knoess presented the
set of requirements for herbal medicinal products including quality, safety, efficacy, labelling, advertising and
pharmacovigilance. He also expressed his wish to have
clear definitions of the different legal categories of products,

which

would

allow

better

categorisation/

distinction of medicinal products, food supplements,

medical devices and cosmetics.

Werner Knoess

Switching: A mega trend?

Suneet Varma

Switching is not just a mega trend, it is a necessity for our industry, stated Suneet Varma, President of
Pfizer Consumer Healthcare. He addressed the benefits of a potential switch of statins in the U.S. in the
context of efficiencies, outcomes and savings.
Faster access in case of emergency, convenience for patients and savings of
healthcare resources were key reasons for
switching ellaOne to OTC, said Frdrique Welgryn of HRA Pharma who analysed the recent switch of an emergency
contraception

pill

ellaOne

(ulipristal

acetate) through the EU wide centralised

procedure. HRA Pharma estimates that
thanks to switch of ellaOne from prescription to non-prescription status over 48
million more European women will be able
to get the morning-after pill. Such a broad
impact was possible thanks to the successful

use

procedure.
Legislators need to ensure that self-care is at the
heart of the healthcare system, said Darragh
OLoughlin, President of the Pharmaceutical Group of
the European Union (PGEU). The regulatory environment must be balanced, proportionate and focused
on meeting the needs and expectations of patients
and other stakeholders. According to the studies presented by PGEU, patients in many countries prefer to
access self-medication in pharmacies, even when available from other sources. Switching naturally expands
the role of pharmacists said OLoughlin.
10

of

the

EU

centralised

Meeting report

We urge the national medicines agencies to be

sensitive to the changing society of increasingly
empowered citizens said Beln Escribano, on behalf of the Spanish Agency for Medicinal Products
and Medical Devices (AEMPS). She explained the
way AEMPS enables access to information on medicinal products including a dedicated mobile application, a regional e-prescription system listing
both OTC and Rx medicines and guidance on umbrella branding.
Frdrique Welgryn, Beln Escribano, Darragh OLoughlin, Suneet Varma and Hubertus Cranz

How to ensure availability of safe products?

Protection of human health and product safety
are number one priority for the industry stressed
Vincent Warnery, Senior Vice President of Sanofi
Consumer Healthcare Division. He noted that the
safety of medicinal products needs to be put in
the

context

of

benefit-risk

balance.

He

highlighted that this is a part of the responsible

approach of the consumer health industry and
needs to be addressed in the continuous dialogue
with the health authorities.
Vincent Warnery

Natalie Gauld, Director at Pharmacy Projects in New Zealand, explained

the positive experience of her country with a number of switches of medicines from prescription to non-prescription status. She explained that only
accredited pharmacists with a completed training can supply emergency
contraception and that the mandatory pharmacists training is also used
elsewhere, e.g. for vaccines in Australia, hormonal contraceptives in California or for patient group directions, e.g. trimethoprim (cystitis), oseltamivir (influenza) and sildenafil (erectile dysfunction) in the UK.
The unique reclassification

of

Natalie Gauld

vaccines

from prescription to
non-prescription status in New Zealand
was explained by Alison van Wyk, Head
of Professional Services at Green Cross
Health.
Alison van Wyk
11

The UK government policy

is to widen access to medicines which enables best
use of healthcare professional resources and supports
patient
through

empowerment
self-care,

stated

Sarah Branch, Deputy Director at the Medicines and

Healthcare products Regulatory Agency (MHRA) in the
UK. Branch said that this leading role is reflected in the streamlined MHRA
classification guideline which focuses on benefit/risk analysis, early discusSarah Branch

sion with the regulators and early engagement with stakeholders.

The session then moved to the topic of falsification of medicines and provided an update on the work in Spain and on the European level. The Spanish perspective on the implementation of the EU Falsified Medicines Directive was given by Beln Escribano, Head of the Pharmaceutical Inspection and Enforcement Department at the Spanish Agency for Medicinal
Products and Medical Devices (AEMPS). Escribano highlighted that the
new requirements should effectively decrease the risks of falsified medicinal products, increase the quality of medicinal products and reinforce the
supply chain against falsified medicinal products including on-line supply
channels.
Beln Escribano

The new EU rules on safety features were explained by Stefano Soro,

Head of Unit Medicinal products quality, safety and efficacy at the European Commission. The EU Falsified Medicines Directive introduces obligatory 'safety features' to allow verification of the authenticity of medicinal products for human use ('unique identifier'). The European Commission prepared a delegated act on safety features which has been extensively discussed with the EU Member States. While prescription medicines
will have an obligation for the safety features, the OTC medicines shall not
bear the safety features unless they are at a serious risk of falsification,
explained Soro. OTC medicines with safety features will be included on a
so-called black list of exceptions. The European Commission foresees
that the new delegated act will be published in the Official Journal of the
Stefano Soro

European Union by the end of 2015.

Vincent Warnery, Alison van Wyk, Natalie Gauld, Sarah Branch, Beln Escribano, Stefano Soro
12

Meeting report

Perspectives for the future

Peter Liese, Member of the European Parliament, reflected on the future of the health care sector. Dr Liese
highlighted that the year 2015 marks 50 years of pharmaceutical legislation as the first directive related to
medicinal products was adopted in 1965. He raised important questions on the future of financing the
healthcare system in the long run and how to best manage the impact of significant therapeutic innovation
on health care budgets. In this context, self-care and consumer empowerment will play a key role.
Dr Liese was also wondering if there is a need for more European coordination of Health Technology Assessment and the possible future role of the
EMA in this respect. Regarding the future of the food legislation, Liese referred to the ongoing discussions on the new Novel Food Regulation as well
as to the pending issues related to the Claims Regulation such as nutrient
profiles and the scientific assessment of botanical health claims. According to
Dr Liese all health claims, including botanicals, should be evaluated by EFSA.
Concerning medical devices, Dr Liese shared his wish that the ongoing revision of the medical devices legislation will progress quickly and that the three
EU Institutions (European Commission, Council of Ministers of EU Member
States and the European Parliament) will find a reasonable compromise.

Pieter Liese

Noel Wathion, Chief Policy Adviser at the European Medicines Agency (EMA),
acknowledged that important changes in the regulatory environment require
both regulatory authorities and pharmaceutical industry to continuously review the impact on their day-to-day operations. There is a need for continuing dialogue to better understand expectations and needs in order for the
most cost-efficient approach to be developed, said Wathion. Particularly
challenging in this context are the new pharmacovigilance requirements and
all the work around the new IT systems.

Noel Wathion

Invitation to the 52rd AESGP Annual

Meeting in 2016
The Conference was concluded
by the invitation of George Dokios, Executive Director of the
Association of the Greek SelfCare Industry EFEX, to the 52nd
AESGP Annual Meeting which will
be held in Athens from 31 May
to 2 June 2016 .

George Dokios
13