Council position on EU pharma package adopted

Key amendments

The Council’s mandate for negotiations contains several key amendments to the proposed legislation, including:

• Regulatory data protection (RDP) and market protection (MP): the Council has proposed to keep an 8-year baseline RDP, while innovative medicine producers shall benefit from 1 year of market protection, extendable to 2 years if certain pre-defined key objectives are achieved. While this provides the much-needed predictability required by the innovative industry, the modulation of incentives remains and the total baseline of RDP and MP (amounting to 9 years) remains lower than under the current framework (a baseline of 10 years for RPD + MP).
• Access and obligation to supply: the launch conditionality has been substantially reformed by the Council. A new article 56a was added to the proposed directive, enabling Member States to now oblige a marketing authorization holder to make such product available in sufficient quantities to cover the needs of patients in the member state. Member states may request a marketing authorization holder to carry out specific actions, such as including for example submitting a valid pricing and reimbursement application or establishing a roll-out plan. Four years after grant of the marketing authorization, marketing authorization holders should supply the medicinal product continuously in such  particular member state. The Council crucially also proposed delinking the access requirements from RDP and orphan market exclusivity and does not introduce financial penalties when a marketing authorisation holder fails to meet its access requirements. 
• Exclusivity voucher: the Council proposed that the transferred voucher can only be used in the 5th year of the RDP and only on the condition that the marketing authorization holder demonstrates that it’s annual gross EU sales didn’t exceed a 490 million euro in any of the preceding 4 years.
• Bolar exemption: the Council’s position further clarifies the scope of the Bolar exemption and expands it to include activities related to pricing and reimbursement and participation in procurement tenders. This position is particularly generic friendly and shall support an earlier market entry of generic and biosimilar medicinal products. In practice, this means a generic manufacturer can complete HTA submissions and even bid in national tenders for hospital contracts before the originator’s exclusivity expires, as long as actual product sales only happen after expiry. As the European Parliament has made similar amendments to the original text from the European Commission, this is expected to go through in the trilogues.

Next steps: trilogues await 

All three institutions have now adopted their official positions on the pharma package. The inter-institutional trilogue negotiations will now take place and such ‘trilogues’ are expected to last until at least the end of 2025. Particularly the incentives and the access framework are expected to play a major role in the trilogue negotiations.