National initiatives driving

European developments

Alan Main
AESGP Vice President
Bayer Consumer Care AG, Head of Region Europe

Dubrovnik, June 10th, 2010

 Introduction

Incr
g t eas l isation
n gin e n ing
i on/libera
Ch a
ir o nm c ons econom Conso l ida t
l en
v trai
nts ic trends
t ica
poli Increa
si
of OT ng range
C pro
ducts Changing consumer
preferences

Rapidly changing European market environment

challenges both self-medication industry and all stakeholders

Good political climate is of utmost importance

! !
Keep a positive dialogue
Ensure safe use of medicines

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 Priorities and Initiatives of the National
Associations of Self-Medication Industry

! Keep a positive dialogue ! Wider availability of medicines

Confidence in switched medicines
Round table discussions on switch issues
Sustainable Health System
Promoting self-medication as part of public health Empowered Consumers

Cooperation with agencies and authorities Implement Better Regulations

Cooperation with healthcare professionals

Promote pharmaceutical advice
Enhance knowledge about OTC

! Ensure safe use of medicines

!
Information campaigns Educating responsible consumers
Codes of Practice Effective advertising and trusted information

Some recent examples of national initiatives ...

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Keep a positive dialogue
Roundtable discussion on switch issues

UK: Ministerial Industry Strategy Group (MISG), 12/09

Forum with experts representing Health Professional groups, Regulators

Patient/lay groups, Industry, European Commission, PAGB.
Explore the vision for wider availability of self-care medicines

One of the key conclusions:

"There is a need for greater transparency, simplicity, clarity and openness
in the regulatory processes at national and EU level.
Ways need to be found of working together better as
a network in Europe"

will keep the dialogue and reconvene the reclassification task

force and continue to cooperate with MHRA and wider stakeholders.

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Keep a positive dialogue
Roundtable discussion on switch issues

Ireland: Conference "Switch-on-to-Self-care" (2009)

Roundtable with legislators, regulators, pharmacists,

doctors and consumers

Switch-on-to-Self-Care working group (4/2010)

Developing in partnership a proposed self-care framework
within which an increasing range of medicines could be
made available without prescription

Developing a draft guide to switching

Helping companies submit switch applications that the Irish
Medicines Board would subsequently review.

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Keep a positive dialogue
Roundtable discussion on switch issues

Finland: Seminar on OTC and switches (2009)

Cooperation Pharma Industry Finland (PIF) with the

Finnish Medicines Agency (Fimea) to increase clarity
and transparency about switches and to discuss
benefits of OTCs

Seminar was a clear opening to a new kind of very open

and transparent discussion

Seminar initiated a series of meetings on these topics

and this work continues

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Keep a positive dialogue
Promoting Self-medication as part of public health

UK: Self-Care Campaign (March 2010)

Self-Care Campaign Group consisting of Royal College of General

Practitioners, NHS Alliance, National Association of Primary Care, PAGB

Manifesto Self-care: an ethical imperative

calls on politicians to educate and inform people and GPs to help change
the culture of dependency in the NHS around minor ailments.

Press coverage has been very positive with a great deal of debate:
"the research was carried out by the Association of OTC medicines but
the campaign is being led by doctors and nurses with one collective voice
to focus attention on this issue

Its a great example of the NHS and industry working

together"

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Keep a positive dialogue
Promoting Self-medication as part of public health

Spain: 'Now we are ready for self-care medicines' 2009

Collaborative initiative of Grupo Contenidos (Spanish Health Press

Group, Society of Primary Care practitioners, National Patients Alliance,
General Council of Pharmacists, Spanish Pharmacists Federation, anefp

Promoting self-care among citizens and Health Professionals and

treating minor ailments with OTC medicines in a responsible way

Highlighting benefits of self-medication with OTC medicines

Making the health system more sustainable
Promoting consumers autonomy
Allowing public system to cover new treatments
Setting resources free to be invested in research activities
Freeing up GPs time for more medical consultation

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Keep a positive dialogue
Promoting Self-medication as part of public health

Italy: Shift promotion to better allocate public resources

In collaboration with SIMG (Italian Scientific Society of General

Practitioners) ANIFA investigated public savings through treating
less serious pathologies by shifting to self-medication.

The research revealed:

Savings of 9 mio only analyzing some possible diagnosis relating to
digestive system and breathing apparatus diseases
Possible savings for the NHS between 40-110 mio
Increase of patients' expenditure lower than possible public savings

Rationalization of public expenditure together with

responsible and conscious citizens, can support a more
appropriate allocation of common resources

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Keep a positive dialogue
Cooperation with agencies and authorities

UK: BROMI / Product Lifecycle Assessment Team (PLAT)

Continued cooperation between and 'Medicines and Healthcare

products Regulatory Agency' (MHRA) to identify efficiency for both MHRA
and OTC industry

Self-certification of all OTC packaging and leaflets by 2010

Revised PAGB Code of Pack Design supported by MHRA
Pre-vetting of non-member packs

Cooperation with newly established Product Lifecycle

Assessment Team (PLAT)
In March 2009 MHRA set up a division dedicated to non-prescription
medicines

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Keep a positive dialogue
Cooperation with agencies and authorities

Spain: Conferences on OTC communication limits, 2009

Two forums with Authorities of Madrid/Catalonia Autonomous

Region, Association of advertising self-regulation and anefp

Make advertising rules more understandable

Constructive exchange of views

what is acceptable and what is illegal in advertising of OTC
medicines, medical devices, cosmetics, food supplements

Future meetings are scheduled to start a collaboration

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Keep a positive dialogue
Cooperation with Healthcare Professionals

Germany: Green prescription

Promotion of 'green prescription' via daily newspaper for GPs

Sponsoring 13 million 'green prescription pads' which could be

ordered by GPs for free.

Campaign experienced a high acceptance by both

GPs and public due to
Treatment sovereignty
Patient confidence and loyalty
Less strain on budget

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Keep a positive dialogue
Cooperation with Healthcare Professionals

Spain: Creation of self-healthcare award, launch 2009

Rewarding pharmacists for self-care activities

Jury: Representatives from MoH, Pharmacy Universities,

Pharmacists Institutions, OTC industry

Promoting pharmaceutical advice in dispensing OTC

Showing benefits of self-care medicines for citizens in the
pharmacy

Next Step: Second edition of the award together with the Spanish
Official College of Pharmacists, with whom anefp signed a
'Charter of Collaboration' in 2009

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Keep a positive dialogue
Cooperation with Healthcare Professionals

Italy: Support GPs' orientation towards self-medication

At the annual National FIMMG (Italian Federation of General

Practitioners) Congress, ANIFA supported the importance of self-
medication in GPs activity throughout:

A qualitative survey on clinicians aptitude to orientate

patients towards self-medication medicines

A four section workshop on:

self-medication is both safe and effective for citizens and can be a
way for a better allocation of scarce nat. medical resources (SSN)

responsible self-medication can offer GPs the opportunity to improve

their daily practice saving time to treat more serious diseases

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Ensuring Safe Use of Medicines
Information Campaigns

Germany, Netherlands, Ireland

www.arzneimittelscout.de

www.zelfzorg.nl

www.medicines.ie
Certified as trustworthy source of health information
by the Health on the Net Foundation, May 2010

Providing reliable information on OTC products and

topics around self-medication

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Ensuring Safe Use of Medicines
Information Campaigns

UK: Pain management leaflet launched

and the British Pain Society (BPS) published a

Leaflet for pharmacists to use with patients to explain

how to manage pain effectively using OTC medicines
The safe use of medicines in managing pain
How different OTC painkillers work

The importance of reading all pack instructions, labelling and the

need to understand different OTC pain-management ingredients
Guidance on recognising mismanagement of OTC medicines
Recognising issues such as chronic daily headache
Making the best use of all OTC analgesics

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Ensuring Safe Use of Medicines
Effective advertising through Codes of Practice

Ireland: IPHA Codes of Practice

Ministerial approval from Department of Health and children in 12/09

Poland: Codes of ethical actions in pharmaceutical Business

Looking for arbitrational solutions and promotion of ethical action

Greece: 'Code of Conduct for Advertising of Non-Prescription

Medicines'

UK: new PAGB Code in 2009

Confirming long-standing and effective advertising control system for
medicines

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 Member Associations

Keep The Dialogue

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Please note:

All details about the European markets

are available in the AESGP study
"Economic and Legal Framework for
Non-Prescription Medicines"

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