Brussels, 5 July 2012

In a joint policy briefing, Association Internationale de la Mutualité (AIM), the International Society of  Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) argue that with its proposed revision of Directive 89/105/EC, the European Commission is endangering the organisation of Member States'  health systems and their health technology assessment (HTA) procedures.

> Click here to download the joint policy briefing (pdf)

Summary

• The European Commission claims to obtain “faster access to medicines for patients ” by revisiting Directive 89/105/EC known as the “Directive on the transparency of prices” .
   
• However, the new Directive proposal does not meet patients’ interests, as it is solely driven by pharmaceutical competitiveness, to the detriment of public health. For new medicines, shortening review deadlines for reimbursement applications and for price-setting practices is likely to weaken assessment quality and undermine decision-making.
   
• The European Commission is going well beyond its remit by proposing disproportionate sanctions when deadlines are not met by competent authorities. The approach taken by the Commission is unbalanced: stringent requirements are made to Member States (i.e. to deliver exhaustive supporting evidence to companies and to the EU Commission for decisions involving delisting, price drops or freezes) while pharmaceutical companies are granted “rights” such as to ask for price increases at any time.
   
• The Association Internationale de la Mutualité (AIM), the Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) call on Member States and Members of the European Parliament (MEPs) to require the European Commission to refocus its proposals towards measures that would really speed up access to health products that actually meet patients’ needs. For instance, require that the added therapeutic value of a new product is demonstrated and substantiated when applying for a marketing authorisation. That would prompt the collection of relevant data, which would in turn facilitate both medical and economic assessments, thus reducing time burdens.

> Click here to download the joint policy briefing (pdf)

©Prescrire July 2012