AESGP

Amsterdam
15-16 February 2016

Conference report
AESGP Conference with EU Heads of
Medicines Agencies (HMA) during
the Dutch EU Council Presidency

HOW PROPORTIONATE REGULATION HELPS

ENSURE AVAILABILITY OF MEDICINES
Improving the availability of nonprescription medicines through
simplified regulatory requirements
was the key issue of a well attended
conference with the Heads of the
EU Medicines Agencies during the
Dutch EU Presidency in the Royal
Industrial Club in Amsterdam on 15
-16 February 2016.
In his opening remarks, AESGP
President Roger SCARLETT-SMITH
expressed his appreciation that so
many heads of agencies responded
to the AESGP invitation to discuss
concrete ways on how to make
progress in the creation of a single
market for non-prescription medicines.
Many AESGP members feel that the
current regulatory system is too
complex and that many elements
do not add value. Mr Scarlett-Smith
thought that the recent adoption of
the EU Medicines Agencies Network Strategy to 2020 and the
specific reference to improve availability of non-prescription medicines are steps in the right direction. AESGP contributes to these
developments with its own SelfCare Agenda 2020. A draft of this
Agenda was discussed during the
conference.

Mr Marcel VAN RAAIJ, Director for

Medicines and Medical Technology
at the Dutch Ministry of Health,
Welfare and Sport welcomed the
guests on behalf of the Dutch EU
Presidency and supported the plea
for simplification. He highlighted
the busy agenda during the six
months of Council Presidency especially because of a really complex legislative file: the new medical
device legislation.

The Netherlands wish to finalise

this before 30 June 2016 and the
trilogue discussion between the
Council, the European Parliament
and the European Commission are
ongoing. Particular attention is paid
to substance-based medical devices, through the discussion on Rule
21, where indeed the Council and
the European Parliament have not
yet reached an agreement.

Marcel VAN RAAIJ, Guido RASI, Roger SCARLETT-SMITH at the opening of

the AESGP Conference with the Heads of EU Medicines Agencies

Session 1

From LEFT to RIGHT: Hubertus CRANZ, Andrzej RYS, Kristin RAUDSEPP, Hugo HURTS, Andr BROEKMANS

THE IMPORTANCE OF PROPORTIONATE REGULATIONFOR THE AVAILABILITY OF

MEDICINES AND AVOIDANCE OF SHORTAGES
Hugo HURTS, Director of the Medicines Evaluation
Board (MEB), set the scene of the meeting by stating
that regulating medicines in Europe always starts
with a good intention but at the end does not
always solve the issue and gave as example the
pharmacovigilance, variations and falsified medicines
legislations. To his view, the opportunity is often
missed to fix the issue in a more flexible way.
Echoing a principle dear to AESGP, it is important to
keep things simple and flexible. He welcomed the
draft AESGP Self-Care Agenda 2020 which acknowledges that the legislation is indeed fine but the
implementation requires fine-tuning. He also referred to the veterinary medicines area where new
legislation is coming up and pragmatism is needed.
The discrepancy between the objective of the legislation and the final outcome was also pointed out by
Andr BROEKMAN, Director of the Escher Think
Tank at Lygature. Lessons learnt from the implementation of the legislation can make regulatory
instruments more effective. Regulatory science
studies can help assess real-world outcomes of the
system and identify opportunities for improvement.
He reminded participants of the key findings of the
Escher study on mutual recognition and decentralised procedures, sponsored by AESGP and EFPIA.
Putting the emphasis on better implementation was
also the key message of Andrzej RYS, Director of
health systems, medical products and innovation, DG

SANTE at the European Commission. In the next few

years, no revision of the pharmaceutical legislation is planned; the focus currently is on finalising
the medical devices and veterinary medicines legislations. The other hot topics at the moment are antibiotic resistance, health technology assessment and
various developments on the international scene: the
reform of the International Council for Harmonisation (ICH), which after 4 years is bearing fruit and
opening to countries around the globe and associations of other industries, is one of them. Fostering
good international relations, in particular with China
and India, big manufacturers and exporters of active
ingredients, is also key. He also reflected on the new
EMA medical literature monitoring service resulting
from the pharmacovigilance legislation which he
viewed as an interesting new tool for companies.
Anticipating the very last session of the programme,
he closed his statement by saying that technologies
will bring new solutions and eHealth will set a new
way of working.
Nicola BEDLINGTON, the Executive Director of the
European Patients Forum (EPF), also agreed that
proportionate regulation is crucial for patients. With
regard to non-prescription medicines, she reminded
participants of the ongoing Commission projects on
self-care (such as PiSCE). She also firmly advocated in
favour of putting patients at the centre of the
systems and of empowering them so that they
can make informed decisions about their health.

In her presentation, Kristin RAUDSEPP, Director

General of the Estonian State Agency of Medicines,
explained the availability problems affecting medicines, particularly in her country. Medicines shortage
is a complex issue and the solution requires collaboration and joint action of all stakeholders. Many activities and initiatives are ongoing to address this issue
at EMA, Commission or stakeholders level. When it
comes to non-prescription medicines, regulatory
authorities are often unaware as patients or pharmacists are usually finding solutions. The falsified medicines legislation has not solved everything and 2D
matrix is very expensive.
In the Q&A phase, Hugo Hurts asked whether Europe
is an attractive market for manufacturers. AESGP
President, Roger Scarlett Smith, replied that the EU is
indeed an attractive place due to patients aging,
patient empowerment but it could be much more
attractive if it was a true single market. He added
that the range of solutions outlined in the draft
AESGP Self-Care Agenda 2020 would improve the
situation. Hurdles found in Europe make other markets sometimes more attractive.

A company representative replied that even for a well

-known substance like ibuprofen, no company would
run a decentralised procedure with all 28 Member
States as there are still notable differences at national
level and the consequence would be to have a downharmonisation when only one indication remains. To a
further remark that the market needed to be challenged, he added that this was pointless as the country disagreeing with the harmonised leaflet could
easily change the legal status to prescription-only.
Hubertus CRANZ, Director General of AESGP,
wrapped up the session by stressing that proportionate regulation is needed and, although this is in
principle agreed by all, making it a reality is difficult.
Industry calls for a speedy market access and increased knowledge concerning the specificities of our
sector. Health literacy and information is an expectation from the society. The industrys role has to be
recognised with regard to information at large
(information, advertising, brands only way to have
some protection of the business for well-known products). AESGP has set all these priorities in its draft
Self-Care Agenda 2020 which will be finalised
based on the discussions at this meeting and then
presented at the AESGP Annual Meeting 2016 in
Athens.

NEW CHALLENGES IN THE PHARMACEUTICAL MARKET PLACE:

AGEING POPULATION, PATIENT EMPOWERMENT, INNOVATIVE
SELF-CARE PRODUCTS, FALSIFICATION

Session 2

Christa WIRTHUMER-HOCHE, Acting Chair of the EMA Management Board and Head of the Austrian Medicines and Medical Devices Agency, set the scene of the second session by recalling the challenges and opportunities of the 21st century: an increasingly aging population, more long-term and chronic conditions, a changing landscape in the pharmaceutical industry, a changing healthcare landscape with empowered patients and
self-care playing a key role in the European economy, and lastly globalisation of manufacture and supply
chains. She wondered whether the +1 year of data exclusivity in case of significant preclinical test or
clinical data in case of switch (vs. 3 years in the US and Japan) was enough to promote innovation. In
her view, an innovative self-care is part of the answer to the current challenges in healthcare and it
should be adequately encouraged and rewarded.

Conference report

Beln CRESPO SNCHEZ-EZNARRIAGA, Director

of the Spanish Agency of Medicines and Medical
Devices, started her presentation by showing the
path of the patient, who becomes empowered
through education and involvement. The Spanish
Agency (AEMPS) gives access to the electronic version of patient leaflets on its website, includes nonprescription medicines in its list of medicines for
prescription purpose, which allows doctors to recommend and prescribe non-prescription products
and de facto dispels the myth that non-prescription
medicines are of lesser value. She also referred to
the Agencys guidance on umbrella branding which
is being increasingly used, which can be considered
a marker of success. The Agency, in close cooperation with the Spanish AESGP Member Association

anefp, developed a list of indications and applicable models of product information leaflets
(PILs). This work revealed that having a common
Summary of Product Characteristics (SmPC) for
products with the same active substance, dose,
indication, etc., but two different PILs depending
on the condition of prescription-only or nonprescription medicines would be helpful. In addition, package sizes and doses need to be aligned
with the indication. She concluded on the fact that
self-care is today key to healthcare. Medicines
Agencies will be increasingly confronted with a
changing society in which citizens are more and
more empowered to make their own decision and
demand more self-care choices.

John BORG, CHMP and EMA Management Board member from Malta,
echoed the view of the previous speakers that due to the societal
changes, more non-prescription medicines with new indications will be
needed in the future to fulfil expectations from empowered patients. He
referred to the PiSCE project in self-care in the EU as an example of political drive to build the right environment. Regulatory-wise, benefit-risk
models would be useful guides to decision-making. He particularly
referred to the Brass model on benefit-risk evaluation for nonprescription medicines as a very interesting model. As closing remarks, he gave a number of possible solutions to centralised switching:

better involvement of applicants,

improving the communication with applicants e.g. via multi-stakeholder scientific
advice, discussion platform between CHMP,
PRAC, patients, healthcare professionals and
industry
engaging with patients during the procedure
developing dedicated expertise e.g. Scientific
Advisory Group (SAG) on non-prescription
medicines
improving clarity concerning national implementation
making the generation of data possible to
address potential concerns on use as nonprescription.

To Christelle ANQUEZ-TRAXLER, AESGP Regulatory and Scientific Affairs Manager, the availability
of non-prescription medicines in Europe needs to
be addressed (currently only 7 APIs are available
without prescription in all 28 Member States)
and for this reason AESGP was pleased to see
that improving patient access to [....] nonprescription medicines was a concrete objective
of the EU Medicines Agencies Network Strategy
to 2020. She reminded participants of the Tajani
report on the promotion of good governance of
non-prescription medicines which emphasised
the use of non-prescription medicines not only
for minor ailments but also for chronic disease
management and disease prevention in the
frame of the collaborative care concept between
patients, pharmacists and doctors. Looking outside Europe, oxybutynin was made available without
prescription in the US, and New Zealand was the
first country in the world to change the legal status
of sildenafil, calcipotriol and oseltamivir to nonprescription. What about Europe? In Europe, four
medicines were switched using the centralised
procedure (orlistat, pantoprazole, esomeprazole
and ulipristal). To unblock the procedure and provide the possibility to generate data concerning the
availability of a medicine in a self-care environment,
AESGP had developed a proposal including:

Early stakeholder dialogue between the applicant, patients, CHMP members, and healthcare
professionals.
Use of the Brass model on benefit-risk for nonprescription medicines and
Marketing authorisation issued either without a
Post-Authorisation Safety Study (PASS --ideal
scenario) or with a PASS and launch at national
level in 2 phases: first in countries agreeable to
have the product switched and welcome the
PASS study on their territory and then a couple
of years later in the second group of countries
once the PASS data have been generated.

On the issue of falsified medicines also covered in

this session, Beln CRESPO described the steps
taken by the Heads of Medicines Agencies to ensure a harmonised and coordinated implementation
of the Falsified Medicines Directive (Directive
2011/62/EU). According to her, this cooperation
between Member States, EMA and Commission
made a smooth implementation avoiding product
disruptions possible. Another outcome was the links
to 23 national registries of brokers included on the
HMA website. She reminded participants that nonprescription medicines are excluded from bearing
safety features, with the exception of specified
forms of omeprazole which are on the blacklist.

Bernard MAURITZ, Director of Neprofarm, explained that half of the counterfeit medicines are sold over the internet from dubious websites (i.e. illicit channels) and he doubted that the obligatory logo alone would change this. He
explained the various reasons why non-prescription medicines are
exempted from serialisation e.g. that counterfeiters are not interested in
counterfeiting non-prescription medicines given the fact that they are
inexpensive. The only exemption is for products responding to the criteria set
in the legislation and being listed (blacklist). The voluntary application of
safety features on other non-prescription medicines is not allowed. Member
States may require anti-tampering device on all medicinal products, including
non-prescription and safety features on all reimbursed medicinal products.

Conference report

The topic of the electronic leaflet was also addressed. Andrzej RYS mentioned the study on product information realised by NIVEL which will be followed by the Commissions report (called by the legislation).
For AESGP, the package information through labelling and / or package leaflets remains a requirement as
there often is no interaction with healthcare professionals and non-prescription medicines may be used by
the whole family and not only directly after purchase. The package information may however be complemented by electronically-available product information.

Session 3

From LEFT to RIGHT: Peter BACHMANN, June RAINE, Elmar KROTH, Xavier DE CUYPER, Paul CARTER, Peter ARLETT

IMPLEMENTATION OF THE PHARMACOVIGILANCE LEGISLATION: DO WE SEE THE

INTENDED IMPACT IN PRACTICE?
Xavier DE CUYPER, Chief Executive Officer at the Belgians Federal Agency for Medicines and Health Products (FAMHP), expressed appreciation of the opportunity provided by the AESGP conference to have a
discussion between stakeholders and regulators as this will continue to play an important role in the
success of the EU pharmacovigilance system.
First to speak was Peter ARLETT, Head
of the Pharmacovigilance Department
within the European Medicines Agency,
who set the scene and highlighted the
important shift in the coordination of
safety issues from a reactive to a proactive system. Reference was made to
the AESGP Self-Care Agenda 2020 which
sees a need for more simplification in the
pharmacovigilance legislation. According
to Peter Arlett, simplification is a target
outcome of the upcoming revision of the
Good Pharmacovigilance Practice Module V on Risk Management Systems
(RMP).

Specific to non-prescription medicines and crucial to the success of a switch is the use of scientific
advice, now permitted by the formalised link between the Pharmacovigilance Risk Assessment Committee
(PRAC) and the Scientific Advice Working Party (SAWP) with a common member.
The last item of his speech concerned the Medical Literature Monitoring system provided by the Agency
which will look at service improvements based on industry feedback.
Elmar KROTH, Director of the German Medicines
Manufacturers Association (BAH) and member of
the AESGP Pharmacovigilance Committee, echoed
some of the successes of the pharmacovigilance
legislation, notably in terms of simplification with
a reference to the Article 57 database use for the
purpose of notifying changes to QPPV details.
However, there is a clear plea for a more riskbased approach which should take into consideration the fact that the vast majority of nonprescription medicines are nationally authorised products, meaning that all procedures need
to be consequently adopted at national level.
A strategy should be identified to make the Medical Literature Monitoring system more beneficial, in
particular through a simplified data exchange between the Agency and companies and a more harmonised approach between European and other world regions. Solutions could possibly be found during the monthly pharmacovigilance cluster between the European Medicines Agency, the United States
Food and Drug Administration (US FDA) and Health Canada, with the participation of Japans Pharmaceuticals and Medical Devices Agency (PMDA) as an observer.
The industry experience on referral procedures
was provided by Paul CARTER, Global Head
Consumer Health Care, Development, Medicine
and Regulatory Affairs within Boehringer Ingelheim, a company concerned by an almost twoyear long procedure. The different formulations
and indications, correlated with specific different profiles in terms of safety, have added to
the complexity of the ambroxol/bromhexine
referral. Ambroxol and bromhexine have been on
the market respectively for more than 30 and 50
years with an exceedingly well-established use
lined with millions of patient-years in terms of
safety data. Being the originator of both substances, Boehringer Ingelheim had also built an extensive database for ambroxol and bromhexine. The
referral started at the end of the PSUR work-sharing procedure in Europe. Two points were at the heart of
the referral procedure: an increase in the rate of reporting of hypersensitivity, which was found to be an
artefact from the Chinese use of the product in the post-operative pulmonary complications (PPC) indication, and Severe Cutaneous Adverse Reactions (SCARs) with a question as to whether this is a temporal or a
causal factor of the use of ambroxol/bromhexine-containing medicines. The moving target from safety to
efficacy questions was a serious threat in the procedure, with some views within the PRAC that the benefit/risk of these medicines was negative.

Conference report

The 8-week period to provide responses to the PRACs list of questions thereby not allowing alignment with
industry partners and the difficulty to provide data on the clinical use, which is hard for well-established
substance, were also challenges. Real-world data (how do physicians/consumers/pharmacist value and use
our products?) provided by the company was ignored by the PRAC. There has to be a different way of
assessing well-established products by taking consumers views into consideration said Paul Carter.
Dialogue and communication along the process should also be facilitated.
June RAINE, Chair of the European Medicines
Agencys Pharmacovigilance Risk Assessment Committee, recognised that referrals need to be used
wisely and carefully; in practice, the number of
referral procedures went from 18 in 2013 to 5 in
2015 with no urgent review since July 2014. Thanks
to a collective work of everyone engaged in these
important new procedures, effective signal detection, effective PSURs and proactive risk management plans, we are in Europe for the very first time
over new risk. said Dr Raine. The possibility of
setting a different timetable in line with the
data, responses and emergency of the matter
has to be reflected, especially for wellestablished substances.
An update was also provided on the two ongoing surveys: feedback is expected in Q3 2016 on the codeine
study which uses the IMS data from France, UK and Spain, while the qualitative and quantitative studies on
combined hormonal contraceptives are still ongoing.
Last to speak was Peter BACHMANN, Chair of the
Co-ordination Mutual Recognition and Decentralised procedures-human (CMDh), who provided
further insight on the referral on fusafunginecontaining medicines initiated in September 2015.
The rationale behind this decision was linked to an
Article 107 (1a) Urgent Union procedure which
means that, for medicinal products authorised
through a mutual recognition procedure or a decentralised procedure, the case shall be brought to
the attention of the CMDh in cases where a referral
was not initiated.
According to Peter Bachmann, in case of safety issues for purely nationally authorised products, companies should consider work-sharing variation applications for updating the product information of these
products with regard to safety information and avoid duplication of assessment. According to Mr Bachmann, this is what went wrong for fusafungine-containing medicines, as the marketing authorisation holder
chose to submit purely national variations at different points in time in different Member States in order to
update the SmPC. Consequently, the non-harmonisation in the SmPC updated wordings was informally discussed within the CMDh in March 2015, with a proposal for a common harmonised wording further discussed
in April. Member States felt the need to reassess the contraindications of fusafungine-containing medicines in
children without having the possibility of properly reviewing this concern within the scheme of any procedure.
In May 2015, the CMDh concluded that a change of PSUR would be requested; however, considering that the
outcome of an assessment of a PSUSA would only be available in several months, it was concluded that a
referral procedure could be pursued, which was done four months later at the request of Italy.
In general, all speakers agreed and converged on the need to place real-world evidence in the centre of
scientific discussions in the future, which AESGP hopes to see duly applied.

Session 4

MAKING PROGRESS IN REALITY

Guido RASI indicated that he took notes of the

many suggestions given during the day. The EMA is
committed to improving every day. The network
strategy 2020 has for objectives to facilitate access
to medicines through appropriate classification,
improve patient access and ensure that the mechanisms for reclassification are in place. One can
ponder why the EMA has granted only 4 positive
opinions for non-prescription medicines and what
the patient needs. There is however no point waiting for the ideal medicine as it does not exist; we
need to act now. The patient needs to be empowered to be able to manage non-prescription
medicines and we need to be reassured that they
can do it. Patients are already core to EMA activities
throughout the lifecycle of products and take part
in many EMA activities e.g. orphan medicines,
scientific advice, paediatric investigation plan,
marketing authorisation application evaluation,
post marketing-authorisation. Information and
advice from healthcare professionals can empower
patients and result in better self-medication
choices. There currently is an incredible number of
data consumer data, social media, apps, pharma
data, test results, claims databases which is untapped potential. Could this pool of data help
plan for a switch or address some of the uncertainty around a switch? He advised engaging

early with regulators to plan a switch and discuss the evidence that can/should be generated.
It is important to reconcile real-world evidence,
enable patients and plan a switch at the beginning of the lifecycle of a medicine so that the
knowledge can be generated in time. Real-world
data (RWD) can be used to get evidence and check
the initial hypothesis. Many RWD initiatives are
ongoing in Europe at the moment. There is the
opportunity to use new technology and realworld evidence to empower patients. Connected
to this, he announced that the EMA will hold a
workshop on big data in the near future to get
guidance on how to use them and not be misled.
Guido RASI ended his presentation by wondering
whether now is the time for switch by design.

Jonathan MOGFORD from the MHRA gave Ian Hudsons presentation given that the latter had to cancel his participation at
very short notice due to illness. He referred to the EU Medicines
Agencies Network Strategy to 2020 which will be supported by
separate individual multi-annual work plans (MAWP). The HMA
MAWP, which is aligned with the EMA MAWP, contains 11 overarching priorities which are declined into 63 individual actions.
Amongst the 11 priorities are: antimicrobial resistance, availability
of appropriately authorised medicines, innovation and access to
new medicines, support for better use of medicines. He gave a
glimpse of individual actions contained in the draft MAWP:

Jonathan MOGFORD

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HMA will continuously explore the harmonisation of criteria and the removal of unnecessary
national requirements to reduce the administrative burden of registration processes in
Member States
HMA will explore other ways to reach agreements between Member states regarding nonprescription products, to facilitate a greater
number of product switches
Optimisation of the regulatory framework,
including continuing to collaborate to reduce
regulatory burden where appropriate, having
captured the needs and expectations of stakeholders
Proactive engagement with stakeholders on
key strategy areas and agreeing joint plans of
action
Develop more streamlined mechanisms to
obtain regular feedback from key stakeholders
on the operation of HMA activities and the
quality of the output

This week will see the publication of the MHRAs

work over the past year on the UK stakeholder
platform on the reclassification of non-prescription
medicines. Jonathan Mogford emphasised the

importance of stakeholders involvement in the

reclassification process and in the near future to the
use of real-world data. Further work to be done
within this initiative includes measuring and documenting outcomes, reviewing the reclassification
process, and considering options for a proactive
approach to reclassification. As concrete step, a
detailed Communication and Engagement plan has
been developed to publish the work of the platform, take forward some of the outputs and increase engagement with the reclassification process. Key performance indicators (KPIs) will also be
looked at in addition to specific measures.

Luca PANI, head of the Italian Medicines Agency and chair of

the EU Telematics Management Board presented the current
telematics landscape. Everything is IT nowadays: pharmacovigilance, clinical trials, marketing authorisations, etc. The main
difficulty is that IT is a moving target but it evolves without
making mistakes (contrary to human beings). The Common
European Submission Portal (CESP) became the Common European Single Submission Portal (CESSP) and is part of the Telematics future landscape within the ISO IDMP implementation
road map. The SPOR (Substances Products Organisation
Referentials) Master Data Management will be feeding data into
the CESSP 1.0, PSURs, referrals, pharmacovigilance, GMP/
inspections, clinical trials, etc. and will de facto cover the entire
product lifecycle management. The Referentials part of the SPOR
services will go live in August 2016, the Organisation in November 2016 and the Product and Substances in Q1/Q2 2018. The
benefit of the SPOR Master Data is that data entered once
will be reused many times, which can lead to operational
savings and efficiencies; it will be a single source of truth
held centrally for substances, products, organisations and
Luca PANI
referentials, thus leading to better decisions and therefore
to faster regulatory actions. He warned that it is a long-term
programme and advised companies to start now to reap the benefits and avoid non-compliance. Companies should perform a gap analysis: a significant number of structure data is expected to be submitted
only 15% of the data are structured in the system and a high percentage of the data needs transformation,
manual extraction (e.g. labelling, SPC, documents, module 3) or a new process for data collection.

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Companies should have in mind that change is the

only constant and companies should therefore be
prepared to be flexible (10% margin in terms of
resources). With regard to the eXtended EudraVigilance Medicinal Product Database (XEVMPD), about
450.000 products are coded and the work is bearing
fruit as changes in QPPV and PSMF location can be
made via a simple update of the database, waiving
the need for variations. He gave the example of a
shared certified Pharma database (Fakeshare.eu)
which was developed to report counterfeit or falsified medicines, manage data about theft of medicines and illegal e-pharmacies. The use of a common set of terminologies and procedures will help
the standardisation of information on medicines.
The discussion that followed on big data and the use of smartphone applications gave a glimpse on the future.
Trust is a word that came a lot during the day said Roger SCARLETT-SMITH in his closing remarks. Trust
into the regulatory system, trust that the patients will do the right thing, etc. Within the context of the existing
legislation, we need efficiency, speed, we appreciate the pharmaceutical regulatory framework which
provides fair conditions to market but the EU is not yet a single market. The regulatory system needs to
take into account the specificities of non-prescription medicines and industry has to make that distinction
very obvious. The Canadians decided to have a comprehensive and fresh look at their regulatory system: we
should take it as an inspiration for Europe. Concerns are too many times raised for old ingredients. The trend
of digital communication is the stunning theme of this generation access to all kinds of data is almost at the
grasp of consumers. There is a trend towards the Uberification of healthcare; what impact will this have in
the future?
In his closing remarks, Stan VAN BELKUM, Deputy Director of the
Medicines Evaluation Board (MEB), found the conference exciting
and pointing to very important issues:
Shortages is really a problem and we need to find ways to live
within the rules in a more intelligent way, taking into account the
global dimension we are now living in.
Seven APIs have non-prescription status in all Member
States. We keep on talking about patient empowerment but we
need to make this happen. The setup of a working group on
non-prescription medicines is a good idea. Patients need to be
provided with more choices and more information. Creating a
SAG might be a good first step to improve the system.

Stan VAN BELKUM

On future and IT we all have to pay our personal contribution

to this development and combine forces to leverage benefits of IT.
The Article 57 database needs to play a role in a proportionate
deregulation and there is the necessity to include more elements
beside QPPV and PSMF location which manufacturers should be
able to amend without going through a variation.

At the end, conference participants were invited by the AESGP President to the AESGP Annual meeting taking
place in Athens from 31 May to 2 June.

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