The European Paliament has continued its deliberations on the ‘Pharma package’ (see ‘The Pharma Package and its implications for homeopathic and anthroposophic medicinal products’  March 2009). Here we provide a brief update on the progress of the Commission’s  proposals.

 Pharmacovigilance Reports by Linda McAvan (S&D, UK) were discussed and adopted in the ENVI Committee on 25 January. The Commission’s two original proposals – on the Pharmacovigilance Regulation and the Pharmacovigilance Directive respectively - were welcomed in principle. Amendments focused on reinforcing the proposed EMEA European Pharmacovigilance Committee, extending the number of its members to one representative per Member State and to two patient and health professional representatives. Other amendments addressed the EudraVigilance database , which should contain the possibility of EudraVigilance immediately transmitting the information on Adverse Drug Reactions communicated by pharmaceutical companies to Member States.

The Committee on Internal Market (IMCO) also discussed the pharmacovigilance proposal, and agreed that it needs fine-tuning. It was underlined that the existing system does not work well, primarily due to under-declaration of undesirable side effects of medicines. In his report, Rapporteur Claude Turmes (Greens-EFA, LU) states that it is useful for patients to participate in identifying unwanted effects. However, since patients are not experts it is necessary to put in place a system based on regional and national centres to filter information provided by patients.

Counterfeit medicines: The ENVI Committee is also in the process of considering a report on the Commission proposal for a Directive in relation to counterfeit medicines (Rapporteur: Marisa Matias (UEL-NGL - P). This welcomes the Commission proposal in this area as a necessary step to respond to this rising health threat and to better ensure patients’ safety. Amendments relate to

·         a need for better definitions and responsibilities of the items involved

·         strengthening sanctions in order to reflect the criminal nature of the offence

·         broadening the scope of the proposal to include internet sales, considering it as part of the illegal chain of supply

·         increasing public awareness of the risks of buying medicinal products through the internet.

In his report on the proposal on combating falsified medicinal products, IMCO Rapporteur Régina Bastos (EPP, Portugal) asks the Commission to clarify the concept of ‘falsified medicinal product’. She also suggests the use of appropriate sanctions, since falsification is a serious offence. Bastos also maintains that, in the name of commercial confidentiality, information on safety measures should not be made entirely public.

For both items, pharmacovigilance and counterfeit medicines, amendments have been tabled allowing for special rules for homeopathic medicinal products or their exemption from certain obligations.

The draft reports will be discussed in the ENVI Committee on 27 and 28 April. The ENVI Committee will vote on the amendments tabled during their meeting on 27 and 28 April as well. Plenary voting and possible adoption of the draft reports for both items is scheduled for 14, 15 or 16 June in Strasburg.

Christine Marking
ECHAMP Public Affairs Consultant