Pharmacovigilance - legislative update

The Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) Report was adopted by 559 votes in favour to 7 against with 12 abstentions, with a compromise amendment. The text is available here

Pharmacovigilance (amendment of Directive 2001/83/EC) report was adopted by 569 votes in favour to 8 against with 15 abstentions, with a compromise amendment.

The text is available here

A summary of the debate in plenary is available here.

MEPs in the ENVI Committee voted on Tuesday 27 April to adopt the draft report by Rapporteur MEP Linda McAvan (UK, S&D). The Committee voted in favour of both the draft report on the proposal for a Directive, and the draft report on the proposal for a Regulation.

The report proposed an EU-wide symbol, to be decided upon by the Commission, to denote that a medicine is new or contains an active ingredient that is being monitored. Whilst support was lacking for the Commission’s categorisation, “intensively monitored product”, consensus was reached on the renamed “additionally monitored product”, so as not to frighten or confuse patients about the medicine’s safety. The ENVI report also expanded the Commission text to allow for alternative methods of reporting, so as to ensure patients are not restricted by lack of internet access or inability to contact their physician. MEPs emphasised the importance of universal access to reporting facilities and the need for a “no blame” legal culture to protect those who experience ADRs and report them.

Issues surrounding the wording and content of pharmacovigilance information in the patient information leaflet (PIL) are to be dealt with in a separate revision, within 18 months of the Directive’s implementation. The European Parliament is due to vote on the draft pharmacovigilance report during the plenary session in June.

A comparison of the ENVI and EPHA positions can be found below.

** Update March: IMCO Opinions on Pharmacovigilance adopted**

In the IMCO Committee, the work on pharmacovigilance is now closed. Rapporteur Claude Turmes MEP (Greens, EFA, Luxembourg) had released its draft opinion on the Pharmacovigilance Regulation, as well as his draft opinion on the Directive, which have been analysed and discussed at lengh. A vote on the file took place and the opinions of the IMCO Committe adopted on 24 February and 5 March. The final opinions are available here and here.

** Update: Draft reports on Pharmacovigilance are available in the European Parliament**

Linda Mcavan MEP (S&D, UK), the ENVI Rapporteur on Pharmacovigilance, released her draft report on the Pharmacovigilance Regulation, as well as her draft report on the directive.

Michele Rivasi MEP (Greens/EFA, France), rapporteur for the ITRE Committee has also drafted opinion on the Pharmacovigilance Regulation, available here, as well as her opinion on the Directive- available here.

**Update November 2009- EPHA releases its Position on Pharmacovigilance**

On 1 November 2009, EPHA released its updated position pharmacovigilance, which built on its previous one, issued in 2004. The document brings the perspective of the pulic health community on this relevant policy dossier, further to a consultation of EPHA’s membership. The position paper aims at inputting the debate in the European Parliament and Council on the Pharmacovigilance directive and regulation from the Pharmaceutical package. The position is available here.

**Update September 2009** European Parliament begins its discussion on the pharmaceutical package

The European Parliament has begun discussing the Pharmaceutical Package in the ENVI and the IMCO committee in their first session since the introductory committee meeting in July 2009. The Pharmaceutical Package, released by the Commission in 2008, could not be discussed in the previous legislature due to lack of time.

On 1 September 2009 Günter Verheugen, Vice President of the Commission and Commissioner for Enterprise and Industry presented the Pharmaceutical Package to the Environment, Public Health and Food Safety Committee (ENVI). The Package was presented along with several other Commission initiatives that the European Parliament will have to discuss in the coming ter

The Commissioner had already presented the Pharmaceutical Package to the previous ENVI Committee (See **Update February 2009**) and did not talk at length on it this time. Mr Verheugen initially brushed over the two parts of the package, Counterfeiting and Pharmacovigilance and focused on the most controversial part, Information to Patients.

The Internal Market and Consumer Protection Committee also discussed the Pharmaceutical Package but in a little less detail. Christel Schaldemose MEP (S&D) also said that there is no doubt people want more information but she is convinced that providing that information should be independent. She felt that the Commission should have thought about this proposal longer and harder before bringing it to the table.

**Update February 2009** Gunther Verheugen addresses the European Parliament on the Pharmaceutical Package

On Tuesday 17 February 2009, Gunther Verheugen, European Commissioner for Enterprise and Industry, addressed the European Parliament’s Environment, Pubic Health and Food Safety Committee. In his 45-minute speech, Mr Verheugen gave an overview of all the DG Enterprise measures currently being discussed in the Parliament at the moment.

The Commissioner talked at length on the Pharmaceutical Package. He said that the pharmaceutical industry is a particularly "dynamic sector" and that it is particularly important for our "democratic development." He went on to say the health and safety of citizens is an absolute rule over competitiveness in the pharmaceutical market. Commissioner Verheugen said that health is DG Enterprise’s primary concern when it comes to the pharmaceutical industry.

On Pharmacovigilance, the Commissioner talked about the need to monitor already approved pharmaceuticals. He said that "we need to be aware and able to deal quickly with undesirable effects of pharmaceutical products".

**Update: The European Commission Releases the so-called Pharmaceutical Package in December 2008**

Following long delays and much anticipation from industry and health campaigners alike, on 10 December 2008, the European Commission finally adopted the Pharmaceutical Package.

The Package contains four measures, three of them legislative, Pharmacovigilance, Information to Patients and Counterfeit medicines and a Communication on the future of the pharmaceutical industry.

For more information please visit DG Enterprise’s website

Background

Pharmacovigilance Regulation 726/2004 and Directive 2001/83/EC were introduced with a view to strengthen the EU pharmacovigilance system and with the overall objective to promote public health. The amendments are supposed to clearly define the roles and responsibilities of different actors. In addition, they are aimed at helping increase transparency and communication on medicines in order to increase the patient’s understanding and build trust and between patients and health care professionals. Another goal is to develop a collection of data about safety of medicines.

— - EPHA Related Articles

EPHA position on pharmacovigilance EPHA Briefing: Proposed Directive on Pharmacovigilance Call for expression of interest in EMA’s Pharmacovigilance Working Party