EC Proposals Aim to Improve Regional Harmonization and Safety

Brussels (Dec. 10)-The European Commission (EC) issued proposals last week to improve Europe’s pharmaceutical market and patient safety.

One proposal would allow the industry to publish nonpromotional information on the Internet or in health-related publications regarding the drug-product’s ingredients, uses, and effects, according to a Dec. 10 statement on the EC website. “At present, not all Europeans have access to such information, partly because standards differ from country to country,” says the statement.

The proposal would move toward harmonizing practices for providing patients with drug-product information among European Union member states. National authorities would monitor the posted information to ensure it does not violate Europe’s ban on prescription advertising.

Another proposal would require mandatory safety features such as serial codes and seals on packages to protect against counterfeiting. This issue is especially important given that seizers of counterfeit medicines at the EU borders increased 280% between 2005 and 2007, according to the EC website.

Two additional legislative proposals would strengthen the EU’s system for monitoring drugs to ensure their safety. Specific measures, according to the EC website, would include:

• Maintaining the current split of competences between EU member states and the European Medicines Agency, while making clear the respective roles and responsibilities and minimizing duplication of effort

• Strengthening the rules on transparency relating to pharmacovigilance data, assessment and decision-making, and involving stakeholders in the processes including reporting

• Establishing clear standards (‘Good Vigilance Practices - GVP’) for the conduct of pharmacovigilance by both industry and regulators

• Freeing up resources by rationalizing and simplifying the reporting of suspected adverse drug reactions, making the best use of current information technology, and matching the reporting requirements with the level of knowledge about the safety of a specific product.

Additional measures now under discussion, according to the release, relate to making pricing- and reimbursement-decisions more transparent, boosting research, and increasing cooperation with the United States, Japan, and Canada.