Brussels, 29 September 2006
This is the first progress report for the Pharmaceutical Forum. The
Pharmaceutical Forum was established by Vice President Verheugen and
Commissioner Kyprianou in June 2005 to examine the competitiveness of the
European-based pharmaceutical industry and related public health issues. The
Pharmaceutical Forum will take forward some of the most crucial issues
outstanding from the G10 Medicines process, in particular Information to
Patients, Relative Effectiveness and Pricing/Reimbursement. This report sets out
the key areas where progress is being made and the directions for future work in
the form of Conclusions for the Forum to adopt.
The European pharmaceutical industry is making a major contribution to
achieving the renewed Lisbon objectives and in fulfilling the growing needs in
public health. It is a major contributor to Europe’s science base and
employment. However, it is facing a number of serious challenges and is losing
ground vis-à-vis its global competitors.
In parallel, the ageing of the European population, the increasing health
demands of the European patients and the high level of expenditure for
innovative products are putting significant pressure on the social systems and
public health budgets of Member States.
Pharmaceuticals are subject to European as well as to national regulations.
Fully in line with the responsibilities of Member States and the Community, the
Pharmaceutical Forum will provide a platform to discuss and examine major
concerns in relation to EU pharmaceutical policy.
The importance of this sector for economic growth and public health and the
need for action was stressed by the conclusions of the Competitiveness and
Health Councils on 22nd September and 3rd December 2003
respectively in which ministers responded and welcomed the recommendations of
the G10 Medicines Group.
Some of the most crucial and outstanding issues of the G10 process, namely
Information to Patients, Relative Effectiveness and Pricing/Reimbursement, have
been selected as topics to be addressed in the Forum. Three technical Working
Groups, supported by a Steering Committee, have been established on each of
these three subjects in order to prepare the ground for the Forum discussions,
share experiences and explore possible concrete and practical ways forward.
Pharmaceutical Forum members are asked to consider and adopt the first draft
conclusions of each of the three working groups. Collectively these conclusions
will provide the mandate for the future work programme.
Information to patients
The aim of the working group is to advise the Commission on ways to improve
the quality of information on authorised medicines available to European
patients. This will supplement the key role of health professionals in
providing information to patients on medicines and health issues more generally.
Patients are increasingly loaded with different information, provided by
multiple parties with differing objectives and sent through multiple channels
(E.g., the internet). This initiative will cover different topics that could
help improve electronic and non-electronic information for patients and, in
particular, develop a model for a Public Private Partnership that could
implement the recommendations in an effective and sustainable way. It will also
explore the feasibility of establishing a database of comprehensive and easily
The Forum’s Working Group on Information to Patients was established in
January 2006. It has developed the following three work streams to:
a) develop a model package of information on diseases (using diabetes as a
b) consider areas for more harmonised action on information on medicines at
an EU level; and
c) improve patient access to good quality health information in healthcare
environments (pharmacies and hospitals and ways to enhance access more
Underpinning the work is a questionnaire that has been issued to all
participants (Member States and stakeholders) seeking details of the main
mechanisms for distributing information on medicines and related health issues
in each Member State.
- The Pharmaceutical Forum welcomes the proposal for developing guidance in
Europe on the production of high quality and easily understandable and
accessible information on diseases and medicines (including prevention where
appropriate) for people in Europe. Such information should also take into
account other relevant treatment options.
New patient information
- According to a set of core principles/criteria and appropriate assessment
and validation procedures to be agreed, on the production of high quality
health-related information for patients and citizens as a framework for
information on diseases and medicines;
- In liaison with authorised databases on diseases and/or medicines, such as
the planned European EudraPharm database;
- Information creation and exchange based on partnerships to be defined
according to different situations (e.g. differences between national health
systems) – possible partners include Member States, patient/consumer
organisations, physicians, pharmacists, other health care professionals,
industry, social insurers and the wider stakeholder community including learned
societies and academia;
- Develop an example on diabetes, based on the above mentioned criteria and
principles, to demonstrate what might be possible; and
- Given the importance of the availability of information to patients in their
language it must be capable of translation into all the official EU languages,
and take into account different capabilities/competencies of patients and
citizens to understand and use such information.
- The Pharmaceutical Forum also welcomes the work being carried out to examine
ways of improving patient access to high quality information on diseases and
medicines (including prevention, where appropriate). Such information should
also take into account other relevant treatment options.
- Through all healthcare environments, with work initially focusing on
hospitals and pharmacies.
- By identifying tools that can help people in Europe to access and
distinguish between good/objective and poor quality information on diseases and
medicines and through all modern communication formats (including electronic and
- By identifying valid national sources of information.
- By exploring methods to support National Competent Authorities to
disseminate and manage information on diseases and medicines.
- The Pharmaceutical Forum notes the contribution of the European Medicines
Agency’s Working Group with Patient Organisations with regard to provision
of statutory information (approved information for health care professionals and
patients) to the work of the Information to Patients Working Group and the
forthcoming launch of the EudraPharm Database.
- The Pharmaceutical Forum also notes that the Commission will take account of
the output of the Information to Patients Working Group in the context of the
Commission’s report to the European Parliament and Council following the
entry into force of Directive 2004/27/EC (amending Directive 2001/83/EC).
- The Pharmaceutical Forum requests the Information to Patients Working Group
to further develop its proposals, in particular in relation to implementation
plans (including the important issues of user-testing and appropriate
validation), and to report back to its next meeting in 2007.
Pricing and Reimbursement
To examine alternative pricing and reimbursement mechanisms to support Member
States in fulfilling their commitment towards the G10 recommendations, as well
as towards the public health objectives of offering an equal access to medicines
at an affordable overall cost. Several factors have generated significant
changes in the pricing and reimbursement mechanisms of most Member States during
the last years: raising expenditure on medicines, inequity of access to
medicines in Europe, the call for early access to innovative medicines. This
Workgroup aims to identify, explore and exchange alternative mechanisms that can
help Member States answer these different challenges. It will be up to each
Member State to see how to apply these mechanisms.
This Working Group was established in February 2006. To start, participants
have raised a variety of concerns and problems, related to pricing and
reimbursement, to be addressed within this group. Most of these were structured
within four work streams which allow a more focused approach:
- Control of expenditure, including use of price control and the variety and
impact of national cost-containment strategies in line with Member State
responsibilities for pricing & reimbursement decisions and ensuring the
sustainability of their health systems.
- Access to medicines, for all patients within Europe, including availability
and affordability issues.
- Market and trade, including organisation of distribution and cross-border
trade of medicines.
- Transparency of pricing and reimbursement data, exchanged between Member
The participants within this Working Group started examining
different national practices relating to the first three work streams, with the
help of independent academic experts. The fourth work stream is more technical
and will be addressed separately within the Transparency Directive Committee
although with regular feedback on progress to the Working Group.
Many participants raised the relationship with the content of the Working
Group on Relative Effectiveness. The chairperson of this group therefore has
ensured coordination with the other Working Group from the start of the
- The Pharmaceutical Forum endorses the progress made in the Working Group on
Pricing to find common ground between ensuring control of pharmaceutical
expenditure for Member States, ensuring a timely and equitable access to
pharmaceuticals for patients all over Europe and ensuring a reward for
innovation within a competitive and dynamic market that also encourages Research
- The Pharmaceutical Forum welcomes the active participation of all key
stakeholders, patients, competent authorities, industry, physicians,
pharmacists, wholesalers and social insurers. The Forum acknowledges that
progress will require involvement and responsibilities of all participants.
- The Pharmaceutical Forum takes note of the key findings of the first
discussions within the Working Group on Pricing and Reimbursement:
- Regarding control of expenditure: Iin order to contain rapidly growing
pharmaceutical expenditure, Member States make increasing use of a variety of
mechanisms, aiming to control levels of price/reimbursement, to rationalise
utilisation. To date there has been limited opportunity to evaluate positive and
negative impacts of these different mechanisms, notably on containment of
expenditure, affordability, access for patients and incentives for industry to
bring further innovation.
- Regarding access to medicines: Not all patients within Europe have equal
access to medicines. Different economic strengths of EU Member States may lead
to different levels of affordability of medicines for both, patients and public
authorities. Certain regulatory measures, market sizes and/or business
considerations may lead to differences with regard to timing of availability of
- Regarding market and trade: Systems for distributing medicines are organised
differently by each of the Member States, in function of local needs and
environment. However, in order to ensure access of patients and citizens to all
medicines there are specific public service obligations for the supply chain.
Parallel imports are not part of organised systems of distribution but they can
increase price competition and can offer an opportunity for cost-containment in
several EU Member States. In other EU Member States, export of these medicines
leads to pressure to accept higher prices and possible stock-ruptures. Such
parallel trade might shift reward for innovation from industry towards trading
- Regarding transparency of data: There is a concern on transparency,
consistency and interchangeability of information and data, regarding pricing,
price components and related issues, exchanged between different Member States
and stakeholders. Although several good initiatives are ongoing in this field,
there is need to further coordinate development and exchange of this type of
- According to the mandate of this Working Group, and in line with national
competencies of the Member States, the Pharmaceutical Forum encourages the
Working Group on Pricing to further progress by:
- Clarifying views on the value of innovation, taking account of national
health systems in order to establish a sound basis for further discussion
between different stakeholders.
- Increasing mutual knowledge on pricing and reimbursement systems and on
different cost containment mechanisms by further exchanging experiences between
Member States and stakeholders. While doing this, taking into account work
already undertaken in different other initiatives.
- Identifying, assessing and recommending ways to ensure incentives for
competition (including on price) and valuable innovation, in particular in line
with the relevant G-10 recommendations on pricing (Recommendations 3, 4, 5 &
- Identifying, assessing and recommending ways to ensure a timely, equitable
and affordable access to medicines for all patients in Europe both within
industry business strategies and within the various cost-containment mechanisms
applied within Member States.
- Identifying, assessing and recommending ways to minimize risks and adverse
consequences for patients, Member States and industry as a result of trade
between Member States.
- Following up on different projects and initiatives within Europe, aiming to
increase transparency, consistency and interchangeability of information
regarding prices, price components and related issues, e.g. within the
Transparency Directive Committee. Where appropriate, giving inputs to increase
coordination between these efforts.
- The Pharmaceutical Forum requests the working group to report back to its
next meeting in 2007.
To support Member States apply relative effectiveness systems in order to
allow containment of pharmaceutical costs as well as a fair reward for
innovation. Relative Effectiveness systems are relatively new for many Member
States and rather complex. Nevertheless the outcome of relative effectiveness is
promising as they will help allow identify the most valuable medicines, both in
terms of clinical efficiency as of cost-effectiveness, and will help set a fair
price for these medicines. The Working Group will bring experiences of different
Member States and of industry together in order to further develop this
This Working Group was established in February 2006. As a consequence of the
wide variety of national relative effectiveness schemes, it was decided to
circulate a questionnaire to all participants to get an overview of different
relative effectiveness practices in Member States. This served as basis for
discussions on definitions and further objectives. This was supplemented by a
further questionnaire focusing on the availability and use of different sources
for information and data.
The chairpersons of this group ensure coordination with the Working Group on
Pricing and Reimbursement on the related issues.
- The Pharmaceutical Forum welcomes the work carried out by the Relative
Effectiveness Working Group towards facilitating exchange of information among
Member States to improve the quality of relative effectiveness assessments for
all stakeholders and to improve the cooperation between Member States.
- It particularly welcomes the report produced by the Working Group on
Relative Effectiveness Assessments in the EU which gives more insight into the
goals and timing of the assessments in the different Member States as well as
the organisation, the transparency, the data used and other methodological
aspects of the assessment.
- It also endorses the proposal for the future work plan which has three
- to develop mechanisms in order to increase the quality and quantity of the
available data to carry out an assessment and to consider ways to manage
uncertainty. The lack of reliable data (notably to support the initial pricing
and/or reimbursement decision) is one of the key challenges to be addressed, and
EU cooperation in this field will help to improve the quality of data for Member
States and to achieve efficient use of limited resources. The Working Group will
also consider possible ways to share information on assessments made and
decisions taken following those assessments, for example by establishing a
database/website. In doing so, the different national legislative backgrounds
for these assessments and decisions must be taken into account.
- to improve the degree of consensus at European level between Member States
on the nature of the data required to carry out cost-effectiveness, relative
effectiveness and relative efficacy assessments and on the procedure and the
time schedule to provide these data.
- to develop a proposal to analyse current assessment processes and to
identify good practices. This work could be used to address challenges in the
assessment processes in Member States.
The Pharmaceutical Forum
requests the Working Group to report back on the implementation of this work
plan prior to its next meeting in 2007.