15 Future of the pharmaceutical sector
| (30292)
17503/08
COM(08) 666
| Commission Communication: Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector
|
| Legal base | — |
| Document originated | 10 December 2008
|
| Deposited in Parliament | 22 December 2008
|
| Department | Health |
| Basis of consideration | EM of 12 January 2009
|
| Previous Committee Report | None
|
| To be discussed in Council | No date set
|
| Committee's assessment | Politically important
|
| Committee's decision | Cleared
|
Background
15.1 The European Community has extensive legislation on the regulation
of medicines for human use; the prevention of counterfeit medicinal
products; and the provision of information to the public about
medicinal products. Article 95 of the EC Treaty provides the legal
base for these measures. It authorises the Council to adopt legislative
measures for the approximation of the laws of Member States about
the establishment and functioning of the EC's internal market.
The document
15.2 The purpose of the Communication is to:
- set out the Commission's vision for the future of the pharmaceutical
sector;
- propose action to give effect to the vision;
and
- put into context the five legislative proposals
— on the counterfeiting of medicinal products, pharmacovigilance
and information for patients — on which we report in chapters
5, 7 and 8.
15.3 The Communication draws attention to the economic
importance of the EC's pharmaceutical industry. For example, it
employs over 634,000 people. Moreover, medicines pioneered in
the Europe have relieved much suffering and helped to give people
longer, healthier and more active lives.
15.4 The Commission says, however, that Europe faces
major health, economic and scientific challenges because:
- it is losing ground to the
USA and Asia in pharmaceutical innovation;
- within the EC, there are inequalities in the
availability and affordability of medicines;
- the sector needs to adjust itself to working
in a global environment, in which, for example, a new medicine
may be the result of research in the EC, clinical trials in India
and the provision of active ingredients from China before the
product is manufactured and packaged for sale in Europe; and
- new scientific discoveries are needed which will
not only revolutionise the development of medicines and the treatment
of patients but also open new markets for medicines produced in
the EC.
15.5 Against that background, the Communication proposes
action over the next few years to make further progress towards
the creation of a single EC market for pharmaceuticals; respond
to the opportunities and challenges of globalisation; and restore
the EC's place in pharmaceutical innovation.
15.6 To give effect to these aims, the Commission
proposes 25 objectives. For example, in addition to the legislation
discussed in chapters 5, 7 and 8, the Commission proposes:
- the development of options
to improve the availability of medicinal products;
- an evaluation of the network of national medicines
authorities to optimise its efficiency and speed up access to
new medicines;
- an assessment of the Directive on Clinical Trials
and, if necessary, amending legislation;
- to help safeguard the public against pandemics,
existing bilateral and multilateral agreements should be strengthened
and extended; and
- existing international public health standards
should be enforced and new standards established to reduce the
risk of unsafe products getting into the market in the EC.
The Government's view
15.7 In her Explanatory Memorandum of 12 January
2009, the Minister of State at the Department of Health (Dawn
Primarolo) tells us that the Communication is in line with UK
policy and supports the Government's aim of working with the Commission,
Member States and others with an interest to improve the competitiveness
of the EC's pharmaceutical sector.
Conclusion
15.8 In our view, the Communication provides a
useful overview of the action the Commission believes necessary
over the next few years to improve the safety, and accessibility
of medicines, strengthen the international competitiveness of
EC pharmaceutical companies and support innovative research. Apart
from the new legislation discussed in chapters 5, 7 and 8, the
Communication does not make binding proposals for action by Member
States. We have no questions to put to the Minister about the
Communication and we are content to clear the document from scrutiny
|
