The Committee of the Regions (CoR) has accused the European Commission of favouring the pharmaceutical industry and ignoring the rights of patients. The EU executive’s proposals - the so-called ‘pharma package’ (see Europolitics3656) - which aim to update rules on pharmacovigilance, tackle counterfeit medicines and improve information to patients on prescription medicines are, according to CoR rapporteur Susanna Haby (EPP-ED, Sweden), “biased in favour of pharmaceutical companies and would put consumers at risk”. Haby’s criticism was reflected in the opinion of the CoR’s Sustainable Development Commission, adopted on 30 June. The member states have also clashed recently with the Commission proposal to amend a regulation on information provided to the “general public” on prescription medicines, which is part of the pharma package (3768).

According to Haby, the fact that the package was drafted by Directorate-General Enterprise and Industry and not by DG Health “tells you all you need to know about who is likely to benefit most from them, although they should have put the interest of the patient first”. She emphasised that the Commission neglected the role of independent local health care professionals when it comes to information to patients on prescribed medicines. In its proposal, the Commission proposes to allow pharmaceutical companies to take the lead on patient’s information but the CoR suggests that this should be done by independent local health care professionals.

Haby was also critical of the proposal to tackle counterfeit drugs. According to her, the new regulation would certainly tighten the current rules but would have the negative side effect “of slowing the entry onto the market of generic versions of branded medicines, in turn reducing competition and consumer choice”.

The European consumer organisation BEUC said, on the occasion of the adoption of the CoR opinion, that it was likewise unhappy with the proposals. According to BEUC, the proposals do not meet consumers’ information needs “as they simply provide pharmaceutical companies greater flexibility to promote their products”.

Over 20 of the member states, on 9 June, did not see the proposal to amend the regulation on information provided to the “general public” on prescription medicines as a solid base for negotiations. As a result, the proposal will be left untouched by the Swedish EU Presidency, which will nevertheless continue to work on the other parts of the package (the package consists of three ‘thematic’ parts and five legislative proposals) on strengthening pharmacovigilance and the battle against counterfeit medicines (3656). According to the member states, the proposal on information to patients makes no distinction between ‘information’ and ‘advertising’. These countries believe that the proposed monitoring mechanisms are too costly and would create administrative burdens. Furthermore, they argue that information about prescription-only medicines should come from “competent health authorities” and not directly from the pharmaceutical industry.