Council publish statements from Member States on SPC waiver

The European Parliament has approved the proposal to amend the European SPC Regulation (EC/469/2009) to introduce a manufacturing waiver. Here we discuss two recent updates concerning the reactions of certain Member States along with the status of the legislative procedure.

Member State reactions

The European Council has published statements from certain Member States addressing their position on the proposed wording.

Denmark, the Czech Republic and Malta all reject the new Regulation:

  • Denmark in particular expressed concern that the amended Regulation could generate significant damage to the pharmaceutical industry, further commenting that the outcome is “disproportionate and goes far beyond what is necessary in order to achieve with [sic] the objective of the proposal”. Denmark also pointed to the lack of “meaningful safeguards” which would undermine legal certainty for all parties involved, and “deteriorate market conditions for investments in research and innovation”.

  • The Czech Republic, whilst recognising the need to maintain a balance, was of the view that the restriction of exclusive rights of SPC holders should only be permissible in “exceptional circumstances such as humanitarian reasons addressing public health problems in developing countries” and considered the geographical scope to be too wide. Malta took issue with the introduction of stockpiling, which had been added somewhat controversially late in the process, and, like Denmark, commented on the unsatisfactory safeguards.

Belgium, France, Ireland, Portugal, Spain and the Netherlands took a different view and issued a joint statement saying that they could support the compromise reached, with the qualification that the position should be carefully monitored and encouraged the need to consider further incentives for research and development to strengthen the EU pharmaceutical sector. These sentiments echo those made by EFPIA in its response to the adoption of the new text by the European Parliament.


In terms of the legislative procedure, earlier this week (on 7 May) the Council published an additional document (an ‘I/A’ Item Note), in which the General Secretariat of the Council asks the Permanent Representatives Committee to suggest that the Council approves the text of the new draft SPC Regulation in the form approved by the European Parliament. If this suggestion is adopted (potentially in upcoming meetings in mid-May) such that the proposal is added as an “A” item to the Council’s agenda, it would mean that the legislation would effectively be approved without further discussion.

It is therefore likely that the new legislation will be approved at some point in the coming weeks. It will then officially enter into force on the 20th day following its publication in the Official Journal of the EU - so likely in June - July 2019.

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