Brussels, 3 March 2009

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On December 10th 2008, the European Commission adopted one communication and three legislative proposals concerning medicines (the so-called “pharmaceutical package”).

A thorough analysis of its content reveals that the EU Commission is upholding the competitiveness of Europe’s pharmaceutical industry thus overriding public interests. Our concrete proposals show another way forward.

Excerpts on Pharmacovigilance:
Key issues of concern
Pharmacovigilance proposals. The proposals on pharmacovigilance have been slightly improved, when compared to the proposals released for public consultation in earlier 2008e. But they are still insufficient to really improve patient safety and, more worrying, could even weaken European pharmacovigilance and marketing authorisation systems. In fact, instead of tackling the reasons explaining the multiplication of pharmacovigilance tragedies due to medicines which were authorised even if they were therapeutic regressions or had an unfavourable benefitharm balancef, the proposals focus on palliative solutions. The proposed ‘risk management’ approach is product-oriented (designed to study and to protect the marketing of the product, but not to protect patients from preventable drugs’ adverse effects). Even though these pharmacovigilance proposals are being presented as a technical matter, pertaining to the pharmacovigilance system, their scope is much wider, affecting every step of the commercialisation of medicinal products in Europe: from evaluation to marketing authorisation, including monitoring and product information.

Some provisions remain extremely worrying:

• calling an end to the mandatory public funding of pharmacovigilance. This public health activity would then be funded by industry’s fees, to be collected by the regulatory authorities. This procedure is likely to make pharmacovigilance decisions akin to providing a service;

• lack of means to really protect European citizens: the Pharmacovigilance Risk Assessment Advisory Committee (PRAAC) will not have enough power to act; the crucial role of National and Regional Pharmacovigilance Centres is not recognised, and the implementation of the Commission’s proposals would even lead to their destruction;

• introducing post-authorisation safety studies and ‘risk management’ programmes that could lead to premature marketing authorisations becoming the norm rather than the exception;

• maintaining the delegation of tasks that must be the responsibility of public pharmacovigilance systems to pharmaceutical companies, even though they are both judge and defendant (i.e. assessment of the data that determine the harm-benefit balance of their product);
   
• lack of transparency: public access to all relevant pharmacovigilance data is not guaranteed; good pharmacovigilance practices (GVP) that are determinant for the organisation of the European pharmacovigilance system are planned to be established in conformity with International Conference on Harmonisation (ICH) recommendations, not from a patient-centred perspective.

Another way forward
Concrete proposals on Pharmacovigilance include:

• more stringent marketing authorisation criteria - a fourth criteria, that of real therapeutic advantage, should be added to the current evaluation criteria of efficacy, safety and quality when granting a marketing authorisation. The therapeutic advance would be compared with existing treatments, and demonstrated by relevant clinical data collected from well-designed comparative clinical trials;

• full and adequate public funding for European, National and Regional pharmacovigilance centres;

• grant increased authority to the Pharmacovigilance Risk Assessment Advisory Committee (PRAAC);

• collect direct patient reporting of adverse effects and exploit this information efficiently;

• increase transparency: label recently approved medicines, particularly if a “conditional authorisation” was granted, with special symbol to raise awarenessk; grant public access to Periodic Safety Update Reports (PSURs), including consumption data, and to extended PSUR assessment reports; grant access to the minutes of the Pharmacovigilance Committee and related working groups meetings;

• impose dissuasive penalties on firms that do not fulfil their obligations, including license withdrawal.

To conclude
One of the EU Commissions’ key responsibilities is the protection of European citizens’ health (article 152 of the European Treaty). Initiatives supporting industrial competitiveness must not be allowed to override public health interests.

More than ever before, we see how placing medicines within the Enterprise Directorate’s sphere of activity has led to a fundamental imbalance in the Commission’s proposals. The organisations endorsing this document call upon the European Parliament and the European Council to require that the Commission reviews its priorities, which should, first and foremost, protect patients’ and consumers’ interests.

Signed: Association Internationale de la Mutualité (AIM)
International Society of Drug Bulletins (ISDB)
Medicines in Europe Forum (MiEF)
Health Action International (HAI) Europe

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