On 10 December 2008 the European Commission released a wide-ranging and significant communication on the initiatives it considers necessary to ensure that the EU pharmaceutical industry contributes to the well-being of citizens through the availability of medicines, economic growth and employment. The communication sets out 25 key objectives and is accompanied by three legislative proposals which address consumer access to reliable information about prescription-only medicines, strengthening of the EU system for pharmacovigilance and counterfeit medicines.
The Commission’s objectives are stated as:
- To improve the availability of medicinal products for patients in need, with a particular focus on smaller markets - to be developed in close cooperation with Member States by 2010;
- Based on an evaluation of the European Medicines Agency (EMEA) ways to optimise the functioning of the network of EU medicines authorities - to be identified by 2010;
- Genuinely transparent and speedy pricing and reimbursement decisions to be made possible by enhancing the application of the Transparency Directive;
- Based on the work of the Pharmaceutical Forum, the exchange of information and cooperation among stakeholders on pricing and reimbursement to be improved;
- Based on the agreement found in the Pharmaceutical Forum the exchange of data between Member States on relative effectiveness should be fostered in order to avoid delays in the market access of innovative treatments;
- Ways to ensure availability and market access for generics and non-prescription medicines should be examined by 2011;
- Launch of an in-depth monitoring of the functioning of markets in the pharmaceutical sector – as to which there is already an ongoing inquiry into the sector, the preliminary conclusions of which are reported in this newsletter;
- An assessment of the application of the Clinical Trials Directive with a view to making, if appropriate, legislative proposals - while taking into account the global dimension of clinical trials - should be presented by the Commission by 2010;
- Proposal to rationalise and strengthen the EU framework on pharmacovigilance to be adopted swiftly – as to which see below;
- The Conclusions and Recommendations of the Pharmaceutical Forum's work on information to patients on diseases and treatments should be taken forward – as to which see below;
- Measures to be taken to ensure that the information provided by the industry to those who seek it is reliable and objective;
- Measures to reduce the potentially harmful impacts of pharmaceuticals on the European environment and public health should be proposed;
- The proposal to prevent the entry of illegal medicinal products into the legal supply chain should be adopted swiftly – as to which see below;
- An intensified exchange of information on illegal distribution channels in relation to counterfeit medicinal products should be proposed by 2012;
- Within IMPACT (the WHO International Medical Products Anti-Counterfeiting Task Force), third countries developing and enforcing legislation against counterfeit medicinal products should be assisted by the Commission;
- To improve international cooperation in the field of pandemics, existing bilateral and multilateral relations with third countries should be strengthened and extended;
- The regulatory cooperation with the US, Japan and Canada within existing confidentiality arrangements, focusing on safety monitoring should be intensified;
- Mutually agreed mechanisms for inspections in third countries should be proposed to these three countries by 2010;
- Bilateral cooperation to be strengthened, including the field of research, with Russia, India and China, focusing on clinical trials and the manufacture of active ingredients;
- Training and information sharing procedures with these three countries should be fostered;
- International harmonisation at ICH and the promotion of the use of international standards by third countries beyond the US and Japan should be further developed;
- Using TEC (EU-US Transatlantic Economic Council) areas for simplification and convergence of rules between the US and the EU and engaging in upstream regulatory dialogue for major legislative proposals should be pursued;
- The EU should work towards the implementation and enforcement of the WTO framework in its bilateral and multilateral contacts, including bilateral Free Trade Agreements (FTAs), in particular as regards the protection of intellectual property rights;
- The effects of the implementation of the Regulation on Advanced Therapies should be assessed and reviewed by 2012; and
- A report on the use of ‘-omics’ technologies in pharmaceutical research and development should be submitted by 2010 and the question of whether new Community instruments are needed to support their development should be explored with stakeholders.
The first legislative proposal is a draft Directive amending Directive 2001/83/EC which inter alia would allow marketing authorisation holders to disseminate, either directly or indirectly through a third party, information to the general public on prescription medicines. Such information could not be disseminated over the radio or on television but may be provided by unsolicited health-related publications, websites and by way of written answers to questions from the public. The draft Directive is accompanied by a draft Regulation adopting the changes in Directive 2001/83/EC for the purposes of centrally authorised products under Regulation 726/2004.
The second legislative proposal is a draft Directive amending Directive 2001/83/EC which inter alia would allow, after the granting of a marketing authorisation, national competent authorities to require a marketing authorisation holder to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. There are other provisions relating to transparency and communication of safety issues and clarification of responsibilities for pharmacovigilance. The draft Directive is accompanied by a draft Regulation adopting similar changes into Regulation 726/2004.
The third legislative proposal, and last so far, is a draft Directive that would amend Directive 2001/83/EC inter alia by requiring greater verification and inspection procedures for medicinal products entering into the EU and into the distribution chain in the EU.
The next stage for these legislative proposals will be a discussion in the European Parliament.