[Ip-health] G10 Medicines: the high level group

[James Love]

who knows about this?

http://pharmacos.eudra.org/F3/g10/p2.htm

     The high level group

      1 - Introduction
      2 - Terms of reference
      3 - Agenda areas of the group
      4 - Ways of working
      5 - Membership
      6 - Timetable


      1 - Introduction
      On 26th March 2001 Commissioners Liikanen and Byrne met health and
industry ministers, pharmaceutical leaders and patient representatives to
establish common ground and agree objectives on a new agenda to improve the
framework for competitiveness in the pharmaceutical industry and to harness
its power to deliver on Europe's health care goals.

      The stakeholders' group will report to Commission President Romano
Prodi in April 2002.

      2 - Terms of reference

      The Group of ten is intended to bring together the top decision-makers
on medicines from the EU. The Group will discuss the major issues relevant
to the right balance of health objectives and industry competitiveness in
Europe.

      It will, in parallel:

      · Contribute during the period covered by its meetings to the ongoing
policy process in the EU through better communication and a fostered sense
of teamwork.

      · Prepare and present, no later than April 2002, a report on its
findings to the College and President of the European Commission, outlining
proposals for concrete action to be taken.

      The group will be time limited, meeting three times between March 2001
and February 2002, presenting its report in April. It will comprise the top
team-members only, discussing short, focused agendas, and working in a
transparent way. The group may issue a joint statement following each
meeting, outlining decisions taken and progress made.

      A secretariat service will be provided by the Commission's
 Enterprise » DG in close co-operation with DG « Health and Consumer
Protection ». All participants will be encouraged to maintain close
communications with one another, and outside views will be sought where
appropriate.

      The Group will review the extent to which current pharmaceutical,
health and enterprise policies achieve the twin goals of both encouraging
innovation and competitiveness and ensuring satisfactory delivery of public
health and social imperatives.

      The group will aim to arrive at a "benchmarking" exercise, which will
examine the ways in which these systems operate, and suggest best practice
for the future.



      3 - Agenda areas of the group

      The group will examine the major areas of concern to private and
public policymakers in Europe, and will cover three main topic areas. It
should be understood that in some cases the distinctions made below are
somewhat artificial, as many of the policy areas are intricately linked.

      a. Provision of medicines to patients

      The medicines industry produces products intended to cure disease and
save lives. How does Europe shape up internationally in terms of
availability of new, effective products meeting Europe's real health needs?
How successfully do member states' health care systems deliver
cost-effective and equitable access to medicines? How could systems of
post-marketing pharmaco-vigilance be improved?

      How to identify the value of innovative medicines in relation to other
pharmaceuticals (where appropriate, generic drugs) and to non-pharmaceutical
interventions, ensuring appropriate and effective involvement of patients?

      Are European medicines systems ready for enlargement? What might be
the effects of adding additional lower-income populations to the equation?

      Central and Eastern European systems, often with lower incomes and
very different healthcare provision, are likely to have a very strong impact
on future policies. They bring with them traditions of social solidarity and
government provision which are even stronger than those in most of Western
Europe - as well as fundamentally different market structures.

      Information and Technology

      What information can patients obtain? How is this managed? In what
ways do developments in ICT affect both information and provision of
medicines?
      What are the issues of competence, and of equity and regulation?

      b. Single Market, Competition and Regulation

      Market structure in Europe

      Pharmaceuticals can not be exempted from the Single Market because
they are used in health care systems. The existence of price controls is not
in itself contrary to the principle of free movement of goods. To what
extent is there scope for development of a single market in healthcare?

      What scope is there for improved competition - between sectors,
between products, on price, on other criteria ? What is the real impact of
fragmentation, and how can it be addressed ? How can the dynamism of the
market be improved ?
      What about the role of funding systems in promoting efficient
consumption of medicines? For example, through improved comparative analysis
of member states' reimbursement decisions and drug consumption patterns?
Through analysis of fiscal and other regulatory mechanisms for influencing
prescribing practices? By means of improved information to patients, and to
purchasers of over-the-counter (OTC) medicines on the efficacy of products?
By attention to the appropriate role of generic products?
      Can we foresee the likely impacts on EU policy in the future? How can
we assure healthcare provision in a changed Union?

      Regulation
      In the past two decades European legislation has been introduced
across the spectrum; it is now being reviewed. Is the balance right? Does it
achieve the right objectives? Can we take an overview of these issues and
build a coherent picture?

      c. Innovation

      Identification of and reward for innovation

      How can purchasers identify innovation? What is the best way of
rewarding it?

      Current European systems use different ways of rewarding innovation.
EU IPR is recognised as being the best single method of rewarding
innovation - giving, as it does, innovative companies considerable market
power. Several issues related to the period of time taken between regulatory
authorisation and actual market access remain to be resolved, and it is
clear that at this stage we have not arrived at a point where products are
"European - marketable" at the same time, or in the same ways.

      Related to this issue, is the question of which innovations to reward
the most. The key to this is whether or not a new product is effective
relative to the treatments that are already available, when and how this
could be proved, and how such information might be made use of.

      The Science Base in Europe

      Looking at ways in which the US system has encouraged basic research;
making comparisons with EU systems; looking for « best practice » in Europe.
      There are several key areas of interest here, related to the ways in
which basic science in Europe is managed. Links between industry and
academia have traditionally been tenuous at best. Questions remain over the
attractiveness of public fundamental research and personnel mobility between
public and private organisations. Ways of remedying these problems have been
attempted at member State level, but there is scope for examining ways in
which leadership and cooperation might be provided at European level.

      Biotechnology

      How can we encourage better uptake and commercialisation of
biotechnology in Europe? What synergies exist between businesses and
academia already, and how might these best be exploited?
      However, there remain issues around public perceptions and
intellectual property where there is scope for improvement. How may these be
addressed?


      4 - Ways of working

      The group will work in accordance with the "Lisbon method", examining
and analysing areas of interest, and seeking where possible to propose ways
forward that might not necessarily require legislation.
      The group will be supported by appropriate expertise to provide an
informed backdrop.


      5 - Membership

      · Erkki Liikanen, Commissioner for Enterprise and Information Society

      · David Byrne, Commissioner for Health and Consumer Protection

      · Ulla Schmidt, German Minister for Health

      · Bernard Kouchner, French Minister for Health

      · Philip Hunt, UK Health Minister

      · Lars Rekke, Swedish Minister for Industry, Employment and
Communications

      · Dr Francisco Ramos, Portuguese Secretary of State for Health

      · Angela Coulter, Chief Executive, Picker Institute

      · Jean-François Dehecq, President and Chief Executive Officer
Sanofi-Synthélabo, President of the European Federation of Pharmaceutical
Industry Associations (EFPIA)

      · Andrew Kay, Chief Executive Officer APS Berk and Chairman, European
Generic medicines Association (EGA)

      · Alessandro Banchi, Board Member Boehringer Ingelheim, President of
the Association of the European Self-Medication Industry (AESGP)

      · Chris Viehbacher, Chairman of Europe, GlaxoSmithKline
Pharmaceuticals

      · Ueli Müller, Président de l'Association Internationale de la
Mutualité




      6 - Timetable

            26 September 2001 G10 meeting
            February 2002  G10 meeting, agreeing final report.
            April 2002 Report to President and College