The three proposals include:

• The fight against counterfeit medicines,
• Improving patient access to health and medicines information and
• Modernizing pharmacovigilance

The pharmaceutical package is a good step towards the improvement of patient safety and access to health and medicines information, and it recognizes the importance of the pharmaceutical industry. However, it is regrettable that the Commission’s proposal does not include a ban on repackaging to better protect patients against counterfeit medicines.

Counterfeiting

Counterfeit medicines pose a serious threat to public health. The European Commission proposes a number of measures to tackle this issue. Amongst others, it has been suggested that certain categories of products – those more likely to be falsified - bear specific safety-features. This may involve the placement of seals which can reveal any opening of the packaging of a medicine. In addition, a product serialization number can facilitate identification and traceability.

The Commission also proposes to strengthen the supervision of actors in the distribution chain. In addition, the Commission advocates measures with respect to the production and import of active pharmaceutical ingredients (API). A database managed by the European Medicines Agency (EMEA) would improve control and ensure only high-quality APIs are manufactured in the EU. Wholesalers, suppliers of APIs and importers are to be controlled by way of mandatory audits conducted by purchasers.

Improving patient access to health and medicines information

Across the European Union, citizens have unequal access to information. The European Commission therefore advocates a clear framework for provision of information by marketing authorization holders about prescription-only medicines to patients. At the same time, the ban on direct-to-consumer advertising of prescription-only medicines will be maintained.

Information is to be provided according to clearly defined quality standards across the Community. The proposal only concerns summaries of product characteristics such as benefits and adverse-reaction warnings. Only certain communication channels such as internet websites on medicinal products, health-related publications and written answers to individual requests shall be allowed, addressing needs of different patients. To ensure compliance with the quality criteria, the information provided will be monitored by Member States.

Modernization of pharmacovigilance

The monitoring of adverse reactions of authorized medicines is subject to the European Union’s pharmacovigilance system. The proposals focus on clear responsibilities, improved transparency on medicine’s safety issues, reporting obligations by industry, and a risk management system for each new medicine.

Reporting obligations by industry are simplified through the introduction of a “pharmacovigilance system master file”. Companies are to maintain a detailed file on site. Safety update reports should also be made simpler and made proportional to the safety respectively the risk of the product.

Future proceedings

The proposals will now be transmitted to the European Parliament and the Council to be debated in the co-decision procedure. If the European Parliament and the Council adopt and publish the proposals, these could become effective at the earliest in 18 months. National enforcement is therefore not expected before 2012.

More information:

• External Link: European Commission’s “Pharmaceutical Package”
• External Link: Counterfeit Medicines