The European Commission published on 28 May 2018 a
proposal1 for a
"manufacturing waiver" to permit third parties to
manufacture a medicinal product protected by a Supplementary
Protection Certificate for the purposes of export to countries
outside the EU. The
Commission aims to have the new legislation in place by
2019.
Background and scope of the proposed manufacturing waiver
The possibility of a manufacturing waiver has been under
discussion since 2015. The present proposal is that the waiver will
be provided by way of a Regulation to amend the existing Medicinal
Products Supplementary Protection Certificate (SPC) Regulation
(469/2009).
The proposed Regulation would exclude certain acts from the
protection conferred by SPCs. In particular, it would permit third
parties to make the medicinal product protected by the SPC for the
exclusive purpose of exporting the product to countries outside the
EU. The proposed Regulation would also permit related acts that
