E-DRUG: New industrial strategy in EU for the pharmaceutical sector
---------------------------------------------------------
[This message is long but is important that we are aware of this strategy. BS]
The EU Commissionar on the strategy the Commission wants to implement to support the pharmaceutical industry. The strategy was presented during a speech given during the European Pharma federation meeting last week. The focus is on three areas: innovation, enhancing competitivness and improving patient information and safety.
Reference: MEMO/05/186 Date: 01/06/2005
MEMO/05/186
Brussels, 1 June 2005
New industrial strategy for the pharmaceutical sector
Together we can make Europe the natural home for pharmaceutical innovation.
Although the European-based pharmaceutical/biotech industry is still a
robust sector making a substantial positive contribution to the Unions
trade balance, employment science base and public health it is declining in
relative terms compared to the United States and growing challenges from
India and the Far East. One of the biggest barriers to responding to this
challenge is that there is no single market in pharmaceuticals: national
systems of pricing and reimbursement, assessments of cost/clinical
effectiveness etc. vary enormously leading to an uncertain climate for
investment and varying access times to the market.
At the EFPIAs Annual General Assembly (European Federation for
Pharmaceutical Industries and Associations) in Brussels on 1st of June 2005;
Commission Vice-President Günter Verheugen has presented the outline of the
Commissions intentions to respond to this challenge beyond the ongoing
regulatory work. (See SPEECH/05/311 and IP/05/641). Below an overview of the
planned new industrial strategy is given.
The new strategy to promote non-legislative competitiveness issues has three
central features: innovation, competitiveness/pricing and patients. The
strategy will build on the platform established by the G10 Medicines
process[1] and the recent adoption of the Pharmaceutical Review in April
2004[2].
Pharmaceutical Innovation
To regain the competitive advantage Europe once enjoyed, the long-term
competitiveness of the pharmaceutical sector depends on support for its
science base. The industry already makes a significant investment in the
science base of around 20 billion per annum (2002).
In April this year, the Commission adopted two horizontal proposals which do
not only support the development of, and research on, new technologies, but
aim also to ensure that their output is of use to the industry: the 7th
Research and Development Framework Programme (7th R&D programme), and the
Competitiveness and Innovation Programme (CIP). These programmes will run
from 2007 to 2013.
The Commission proposes the following initiatives that are aimed to promote
the right environment for pharmaceutical innovation.
Seventh Research and Development Framework Programme
To re-establish Europes R&D leadership in the strategic biopharmaceutical
sector, a significant increase in RTD spending has been proposed by the
Commission. According to the Commission proposal 73.2 billion should become
available to the 7th European Research Framework Programme. Life Sciences
and Biotech will significantly benefit from the planned increase, annual
contributions earmarked for life sciences are to be more than doubled.
Health-related research as an important part of the life sciences industry
will particularly benefit from this stimulus. This support should have a
significant leverage effect on private and public research spending. The
newly defined platform strategy (see below) will be crucial to promote
Europes competitiveness in RTD.
Technology Platform on Innovative Medicines
One important part of the R&D Framework Programme is Technology Platforms.
The work on some of the platforms has already started. The objective of this
new instrument is to foster public-private partnerships at the European
level and bring together academia, industry, Member States and the
Commission to pool Europes limited resources in order to create added
value.
A key technology platform will be the new Technology Platform on Innovative
Medicines. Its main objective is to enhance and accelerate the development
process of medicines so as to ensure the rapid application of scientific
breakthroughs.
This technology platform seeks to meet the technological challenge of
re-establishing Europes research and development leadership in the
strategic biopharmaceutical sector. At the same time, it offers the prospect
of giving the industry in Europe a competitive edge by overcoming the
current bottlenecks in the pre-competitive phase of the drug development
process, notably prediction of safety, prediction of efficacy and knowledge
management, as well as education and training.
Industrys leading role will be crucial as it will ensure that efforts are
focussed on potential future markets and help to reap the economic benefits
of this cutting-edge technology. As part of the strategy the Commission is
determined to ensure that this initiative, especially the Innovative
Medicines Platform, remains industry-focused.
Research focus
Over the last years, therapeutic discoveries and innovations have changed
the R&D process significantly. To accelerate the development of more
effective medicines, the safety and efficacy evaluation of new molecular
entities needs to be improved. The proposed Strategic Research Agenda seems
to focus on the following areas which are considered key bottlenecks in the
R&D process:
Safety
Efficacy including biomarkers identification and validation, patient
recruitment and risk assessment with authority
Knowledge Management, leveraging the potential of new technologies to
analyse a huge amount of information in an integrative and predictive way
Education and Training, addressing certain gaps in expertise which need to
be resolved in order to change and support the biopharmaceutical research
and development process.
Key R&D Areas
The following areas will be primarily addressed (non-exhaustive list
selection of objectives):
Increasing effectiveness of public and private investment in R&D
Facilitate coordination of clinical trials at European scale
Fostering of innovation, competitiveness and productivity
Shortening drug development times
Contribute to removing of obstacles for market penetration of innovative
medicines
Improving public perception of the pharmaceutical industry
Enhancing EU attractiveness as a location for researchers and industrial
investment
Reducing the number of drug market withdrawals and
Improving cost-effectiveness
To achieve these goals it is necessary to mobilise and involve all
stakeholders including patients.
Competitiveness and Innovation Programme
The CIP will be a new streamlined innovation agenda designed to specifically
benefit SMEs and start-ups with a total budget of 4.213 billion for the
period 2007 - 2013. This will be particularly beneficial to
pharmaceutical-biotech companies where SMEs predominate. It includes an
Entrepreneurship and Innovation Programme with a substantial budget of 2.6
billion. It will support actions that develop the capacity of enterprise and
industry to innovate. The programme also includes many new elements
including; a risk capital instrument for High Growth and Innovative
Companies, an enhanced role for innovation business support networks and a
twinning programme for policy makers. Overall it is designed to support
actions that develop the capacity of enterprise and industry to innovate.
More information:
http://europa.eu.int/comm/enterprise/enterprise_policy/cip/index_en.htm
Competitiveness/Pricing
It is the Commissions objective to examine the benefits of giving industry
more flexibility in establishing prices without sacrificing any capacity of
Member States to protect their health care budgets. In addition, this
reflection should look at the speed of access to the market, lifting of
pricing controls for medicines that fall outside the state sector and the
impact of the Transparency Directive (89/105/EEC) which sets out
requirements for the speed and transparency of national pricing and
reimbursement decisions.
Given the importance and sensitive nature of this issue, it is clear that
the Commission will not be able to make quick progress but that is no reason
not to start. The Commission will work with Member States, industry and
other stakeholders to examine a way forward and make recommendations.
In addition to pricing is the issue of relative effectiveness. Most Member
States have gradually introduced formal or informal comparative assessments
of clinical and cost effectiveness. This is entirely a matter for them.
However, Europe is faced with a patchwork of different national systems
which places a significant burden on industry and can delay access to the
market.
It is the Commissions objective is to introduce more consistency; speed and
transparency into national relative effectiveness systems. The Commission
has started work to establish a stock-take of these systems. This,
potentially, could lead to the creation of a core set of common data
requirements for industry.
Safety of patients/information of patients
There are two core issues that need to be addressed: information to patients
and their safety.
Quality information
Improving the quality of information to patients has been an ongoing issue
for a number of years now. It was not satisfactorily resolved in the debate
on the pharmaceutical review. It was not possible to find a balance between
proposals to take account of the modern reality of the Internets capacity
to provide unlimited access to unregulated information, and the concerns
that any relaxation would open the Pandora Box of Direct to Consumer
advertising.
The Commission cannot ignore this dilemma and quick action is required. The
Commission will establish shortly a Public Private Partnership to improve
access to quality information on medicines for the public. The Partnership
will involve regulators, industry, patients and other stakeholders. It
should develop a tool for making high quality information on medicines
easily accessible to the public in their own languages. This should be based
on the work already started by the European Medicines Agency in London. In
particular, take account of the Agencys EuroPharm Database which will
eventually hold information on all authorised medicines in Europe.
Patient Safety
There have been some safety concerns which have highlighted the need for a
review of pharmacovigilance in Europe. It is the Commissions objective to
have a public debate to consider options for improving the safe use of
medicines at both the national and European level. The basis for the public
debate will be an already commissioned independent review of national and
European pharmacovigilance due to report in the autumn of this year.
Conclusions and way ahead
The exact details of the work programme in each area are being finalised.
Mr Verheugen showed himself confident to be able over a period of three
years to deliver some concrete results. Once a year there will be a
Ministerial level Pharmaceutical Forum foreseen to provide a political
impetus to the process and ensure that all Member States are involved and,
as far as possible, take ownership of it. The first Forum is planned for the
Austrian Presidency in early 2006.
All the work areas will require different types of working groups, workshops
etc. to progress work which is at different stages of development. To advise
the Commission on the work programme, and possibly monitor the work of the
individual work streams, it is proposed to set up a steering committee which
would involve a small number of Member States (the 5 Presidencies),
industry, European Parliament and a few selected key stakeholders.
Europe is facing a huge healthcare challenge. The Councils Economic Policy
Committee has estimated that, by 2050, there will be only two working age
citizens for each elderly person in the EU instead of the current Four. The
increasingly elderly population will need ever greater support from
hard-pressed healthcare systems.
We will not succeed in tackling this if we constantly view this as a burden.
There will be enormous growth for the healthcare sector. By investing in
healthcare now we can reap rewards in the years to come through reduced
hospital care and other long term support.
The Commission has established a new modern regulatory framework for the
pharmaceutical sector. It will also be working with Member States to ensure
that the regulatory environment at a national level is equally supportive.
The success of the strategy will depend on close cooperation and partnership
between the Commission/EMEA, Member States, industry, and other
stakeholders. As the G10 process has demonstrated, dialogue and
collaboration is the best way forward.
[1] The G10 High Level Group was established in 2001 to explore ways of
improving the competitiveness of the pharmaceutical sector in line with EU
public health objectives. See http://pharmacos.eudra.org/F3/g10/p2.htm
[2] See http://pharmacos.eudra.org/F2/home.html
-----------------------------------------------------------
Seco Gerard
MSF Access Campaign EU Liaison Officer
C/O MSF Belgium
Rue Dupré 94
B-1090 Brussels
Direct number: +32 2 474 75 09
Fax number: +32 2 474 75 75
Mobile number: +32 479 514 900
"Seco Gerard" <Seco.Gerard@msf.org>