As the legislation is shaped, we are holding meetings with senior officials in the Department of Business, Enterprise and Innovation, as well as some MEPs, to make the case for IP incentives.
The European Commission’s proposal is solely designed to benefit the generics industry. As a principle, we see any proposal to curtail intellectual property rights through an extra exemption as the wrong path forward for Ireland and the EU. It sends a negative signal about support for a robust incentives framework that promote innovation in Europe. Though the Commission’s proposal is drafted as a narrow recalibration of the SPC regime with limited impact in EU markets, we are concerned that the ongoing legislative process might lead to the amendment of the SPC regulation and added erosion of intellectual property rights.
It is important that the Government presses for the application of certain safeguards in the legislation. The manufacturing waiver should be limited to export to countries where there is no intellectual property protection or where it has expired. It should not allow for any large stockpiling during the exclusivity period. Right-holders should be notified sufficiently in advance by generics companies intending to use the manufacturing waiver so that we can ascertain that the conditions for the exemption are met. Any modification to the SCP regime should only apply to future SPCs, not applied retroactively to existing rights. That would equate to confiscation of property rights and potentially trigger retaliation from EU trade partners such as Canada which agreed to implement an SPC-like regime.