AESGP Conference with EU Heads of

Medicines Agencies (HMA) during

the Dutch EU Council Presidency

AESGP Conference report

Amsterdam

15-16 February 2016

HOW PROPORTIONATE REGULATION HELPS

ENSURE AVAILABILITY OF MEDICINES

1

Improving the availability of non-

prescription 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 medi-

cines.

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 Net-

work Strategy to 2020 and the

specific reference to improve avail-

ability of non-prescription medi-

cines are steps in the right direc-

tion. AESGP contributes to these

developments with its own Self-

Care 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 com-

plex 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 devic-

es, 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

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 ack-

nowledges that the legislation is indeed fine but the

implementation requires fine-tuning. He also re-

ferred to the veterinary medicines area where new

legislation is coming up and pragmatism is needed.

The discrepancy between the objective of the legisla-

tion and the final outcome was also pointed out by

Andr BROEKMAN, Director of the Escher Think

Tank at Lygature. Lessons learnt from the imple-

mentation 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 decentra-

lised 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 legisla-

tion is planned; the focus currently is on finalising

the medical devices and veterinary medicines legisla-

tions. The other hot topics at the moment are anti-

biotic resistance, health technology assessment and

various developments on the international scene: the

reform of the International Council for Harmonisa-

tion (ICH), which after 4 years is bearing fruit and

opening to countries around the globe and associa-

tions 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.

Session 1

THE IMPORTANCE OF PROPORTIONATE REGULATIONFOR THE AVAILABILITY OF

MEDICINES AND AVOIDANCE OF SHORTAGES

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

2

NEW CHALLENGES IN THE PHARMACEUTICAL MARKET PLACE:

AGEING POPULATION, PATIENT EMPOWERMENT, INNOVATIVE

SELF-CARE PRODUCTS, FALSIFICATION

In her presentation, Kristin RAUDSEPP, Director

General of the Estonian State Agency of Medicines,

explained the availability problems affecting medi-

cines, particularly in her country. Medicines shortage

is a complex issue and the solution requires collabo-

ration and joint action of all stakeholders. Many acti-

vities 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 pharma-

cists are usually finding solutions. The falsified medi-

cines 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 mar-

kets 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 down-

harmonisation when only one indication remains. To a

further remark that the market needed to be chal-

lenged, he added that this was pointless as the coun-

try 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 proportio-

nate 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 increa-

sed knowledge concerning the specificities of our

sector. Health literacy and information is an expecta-

tion 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 pro-

ducts). 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.

Session 2

Christa WIRTHUMER-HOCHE, Acting Chair of the EMA Management Board and Head of the Austrian Medi-

cines and Medical Devices Agency, set the scene of the second session by recalling the challenges and oppor-

tunities of the 21st century: an increasingly aging population, more long-term and chronic conditions, a chan-

ging 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.

3

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 ver-

sion of patient leaflets on its website, includes non-

prescription medicines in its list of medicines for

prescription purpose, which allows doctors to re-

commend 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 coopera-

tion with the Spanish AESGP Member Association

anefp, developed a list of indications and appli-

cable 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 non-

prescription medicines would be helpful. In addi-

tion, 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 poli-

tical 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 non-

prescription medicines as a very interesting model. As closing re-

marks, he gave a number of possible solutions to centralised switching:

better involvement of applicants,

improving the communication with appli-

cants 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 imple-

mentation

making the generation of data possible to

address potential concerns on use as non-

prescription.

Conference report

To Christelle ANQUEZ-TRAXLER, AESGP Regula-

tory 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 [....] non-

prescription 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 out-

side 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 non-

prescription. What about Europe? In Europe, four

medicines were switched using the centralised

procedure (orlistat, pantoprazole, esomeprazole

and ulipristal). To unblock the procedure and pro-

vide 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 appli-

cant, patients, CHMP members, and healthcare

professionals.

Use of the Brass model on benefit-risk for non-

prescription 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 en-

sure 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 non-

prescription 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 counter-

feit medicines are sold over the internet from dubious websites (i.e. illicit chan-

nels) 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.

The topic of the electronic leaflet was also addressed. Andrzej RYS mentioned the study on product infor-

mation 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 comple-

mented by electronically-available product information.

Session 3

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 Prod-

ucts (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 pro-

active 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 Mod-

ule V on Risk Management Systems

(RMP).

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

Conference report

6

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 risk-

based approach which should take into consid-

eration the fact that the vast majority of non-

prescription medicines are nationally author-

ised 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 har-

monised approach between European and other world regions. Solutions could possibly be found dur-

ing 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 Pharmaceuti-

cals 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 Ingel-

heim, a company concerned by an almost two-

year long procedure. The different formulations

and indications, correlated with specific differ-

ent 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 substanc-

es, Boehringer Ingelheim had also built an exten-

sive 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) indica-

tion, 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 bene-

fit/risk of these medicines was negative.

7

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 Com-

mittee, 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 detec-

tion, effective PSURs and proactive risk manage-

ment 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 well-

established 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 Decentral-

ised procedures-human (CMDh), who provided

further insight on the referral on fusafungine-

containing 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 de-

centralised 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, compa-

nies 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 Bach-

mann, 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 dis-

cussed 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.

Conference report

8

MAKING PROGRESS IN REALITY Session 4

Jonathan MOGFORD from the MHRA gave Ian Hudsons pre-

sentation 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 ove-

rarching 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

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 me-

chanisms 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 wai-

ting for the ideal medicine as it does not exist; we

need to act now. The patient needs to be empo-

wered 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 un-

tapped potential. Could this pool of data help

plan for a switch or address some of the uncer-

tainty around a switch? He advised engaging

early with regulators to plan a switch and dis-

cuss the evidence that can/should be generated.

It is important to reconcile real-world evidence,

enable patients and plan a switch at the begin-

ning 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 real-

world 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.

9

HMA will continuously explore the harmonisa-

tion of criteria and the removal of unnecessary

national requirements to reduce the adminis-

trative burden of registration processes in

Member States

HMA will explore other ways to reach agree-

ments between Member states regarding non-

prescription 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 stake-

holders

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 docu-

menting 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 plat-

form, take forward some of the outputs and in-

crease engagement with the reclassification pro-

cess. 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: pharmacovigi-

lance, 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 Euro-

pean Single Submission Portal (CESSP) and is part of the Tele-

matics 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 Novem-

ber 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

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. Compa-

nies 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.

Luca PANI

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10

Stan VAN BELKUM

Conference report

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 EudraVigi-

lance 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 falsi-

fied medicines, manage data about theft of medi-

cines and illegal e-pharmacies. The use of a com-

mon 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 fu-

ture.

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.

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.

11