On December 10, 2008 the European Commission published its long-awaited “pharmaceutical package.” The “pharmaceutical package” consists of a “Communication on a renewed vision for the pharmaceutical sector” and three separate legislative proposals. The specific proposals would:
- Allow more information about pharmaceuticals to be provided to patients;
- Modernize pharmacovigilance procedures to improve the product safety; and
- Improve patient safety by reducing the infiltration of counterfeit medicines into the supply chain.
The overall goal of the proposed package is to ensure safe, innovative and accessible medicines in the European Union (EU).
Communication on a renewed vision for the pharmaceutical sector
The Communication acknowledges that the EU is losing ground in pharmaceutical innovation to the United States and Asia. The pharmaceutical package is intended to launch a debate concerning ways in which market access for pharmaceuticals can be improved and pharmaceutical research boosted. The Communication proposes 25 measures on a variety of topics, some of which are the subject of the three accompanying legislative proposals.
The proposed measures include steps towards making pricing and reimbursement decisions more transparent, a sensitive issue in the EU for both the Member States and the industry. While the Communication does not propose adoption of pricing procedures at EU level, it does suggest enhancing the application of an existing law, the Price Transparency Directive, increased cooperation among stakeholders, and increased information exchange among Member States.
Proposal on information to patients
The pharmaceutical package includes proposed modifications to existing legislation governing the provision by pharmaceutical companies of information, for the general public, concerning prescription-only pharmaceuticals. The Community Code on Medicinal Products prohibits the promotion of prescription-only products to the public. However, the proposals would permit companies to publish certain types of information about prescription-only medicines, including the patient leaflet accompanying prescription medicines and the product’s summary of product characteristics. Dissemination of such information would be limited to specific channels of communication including the internet and health-related publications, as defined by the EU Member State in which the publication takes place. The proposals specifically exclude the dissemination of such information on television and radio. The proposals include strict criteria that must be respected when information is to be provided to the general public. Information must be objective, reliable, up to date, based on evidence and understandable. It must also clearly state its source.
Proposal on pharmacovigilance
The pharmaceutical package’s proposed modification of existing EU legislation governing pharmacovigilance include clarifying the roles and responsibilities of the key responsible parties, rationalizing EU decision-making on drug safety issues, strengthening companies' pharmacovigilance systems, and ensuring the collection of high quality data. On the latter point, the proposal both demands that companies be more proactive in preparation of complete reports and seeks to simplify reporting obligations where the current reporting burden exceeds the benefits gained. Also, additional stakeholders would be involved in pharmacovigilance, including direct patient reporting of suspected adverse reactions. In addition, the proposal would permit any EU Member State to delegate national pharmacovigilance obligations to another Member State, with the written agreement of the latter.
Proposal on counterfeit goods
Reflecting the continuing battle against the increased presence in the EU market of counterfeit products, the pharmaceutical package includes a proposal to protect against pharmaceuticals that have entered the legal distribution chain on the basis of falsehoods regarding their “identity, history or source.” The proposal includes measures to permit counterfeit products to be more easily identified. These include safety features ensuring full traceability of each individual package of high-risk products. The European Commission believes that the proposal will permit the continued repackaging of pharmaceutical products, permitting parallel trade to continue. The proposal also includes measures intended to ensure that active pharmaceutical ingredients are manufactured to high quality standards and are not falsified.
The legislative proposals will now be submitted to the European Parliament and to the Council of Ministers under the EU’s co-decision procedure, where their content and detail will be debated.