The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the possibility to provide comments in response to this Consultation.

In summary, EFPIA would suggest that:

- A mechanism to allow for resolution of patent disputes, before generic launch, is introduced, as suggested by EFPIA in its Early Resolution Mechanism Proposal.

- Clearer guidance about best procurement practices is issued to the attention of both contracting authorities and tenderers, to ensure full awareness and respect of intellectual property rights, trade secrets and confidential information of tenders within public procurement procedures, thereby safeguarding research and innovation remain among the main drivers of future growth in Europe.

- Tenderers have the obligation to declare that their tender is not infringing any IP right while contracting authorities have the obligation to exclude any IP-infringing tender, including those without declaration.

- For the procurement of pharmaceutical products with several indications, some of which are already off-patent, public tenders should specify the relevant indications.

- For the procurement of on-patent drugs or indications, the negotiated procedure without publication should be used in priority so as to limit the risk for public procurement procedures of infringing IPRs. 

The full Consultation is available here.