New Proposed European Commission Pharmaceutical Regulation – Potential Changes and Impact on Manufacturers With a Focus on Eastern & Southern European Member States

OBJECTIVES: We will evaluate the proposed pharmaceutical legislation in the EU and assess the practical implications on market access for manufacturers

METHODS: By using an analogue, we will compare the proposed legislation vs. the current environment and analyse the difference.

RESULTS: For the proposed changes to the EU legislation, there are several items which may cause concern. In particular, the extension of Regulatory Data Protection (RDP) for up to 2 years if “products supplied in sufficient quantity and necessary presentations within 2 years (or three years for Small to Medium Enterprises (SMEs), not for profit and inexperienced companies) of marketing authorisation in all member states.” Using the analogue Harvoni®, many of the Eastern and Southern EU member states are yet to reimburse the drug, despite it being an invaluable product based on its curative nature and being integral to the treatment of patients with hepatitis C. If marketing authorisation triggers the start of the process, the 2-year target for P&R will be difficult to achieve. Currently, not all member states in Southern and Eastern Europe have agreed pricing and reimbursement of Harvoni® (despite having launched 8 years ago) which means that Harvoni® would only have attained a maximum of 8 years of exclusivity (assuming it had met the unmet medical need, new active substance comparative trials and new therapeutic indication with significant benefit requirements) vs. current option of up to 12 years.

CONCLUSIONS: It may be difficult to achieve the maximum RDP under these conditions. The EU will need to consider how policy changes are going to affect both the smaller member states and manufacturers as this will be a struggle for payers and manufacturers alike and could make Europe less attractive for launching innovative health products