European Commission paper on Brexit and SPCs

The European Commission recently published a short document on the consequences of Brexit on SPCs.

The general message is:

Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products will no longer apply to the United Kingdom. 

The document highlights the following consequences:

- on the calculation of the duration of SPCs:

• An authorisation to place the product on the market granted by a United Kingdom competent authority as of the withdrawal date will not be considered a first authorisation to place the product on the market in the European Union for the purposes of Article 13 of Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96.

• However, an authorisation to place the product on the market granted by a United Kingdom competent authority before the withdrawal date is to be considered as the first authorisation to place the product on the market in the European Union for the purposes of Article 13 of Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96.

- on applications for SPCs as of the withdrawal date in the United Kingdom

As of the withdrawal date, the Medicinal Products and Plant Products regulation no longer apply to the United Kingdom.  The document footnote does indicate that for applications for an SPC filed before the withdrawal date, the EU is trying to agree solutions with the UK in the withdrawal agreement.

 Watch this space.

Brexit: what does Boris Johnson have to say about SPCs?

Fortunately nothing at all,  but after the UK's exit from normality we've been asked what impact there will be on SPCs in the UK?

As SPCs are granted in the UK under an EU regulation, which will no longer apply after Brexit, in the future it will be necessary for the UK to enact legislation to create some form of equivalent protection. Presumably this will not be at the top of the list of priorities for our new PM, and possibly we will adopt the current EU legislation into UK law, but without appeal to the CJEU for obvious reasons.  The possibility remains that any new protection could be of a different scope, but this seems an unlikely outcome given that there will apparently be some other things to do as well.  After Brexit the UK courts will not be bound by the existing CJEU decisions, or be able to refer questions on SPCs to the CJEU, and we may have divergent opinions on similar legal issues between the UK and EU as we move forward.  Given the view of some of the UK judges on the opinions of the CJEU, this could be rather interesting.

There will also need to be a new mechanism for extending the SPC term after appropriate paediatric studies, assuming the UK looks to maintain equivalent protection with the rest of the EU.

SPCs already granted by the UKIPO should be unaffected, but could potentially have a different validity if the law that applies to them is interpreted differently by a court free from the constraints of CJEU decisions.

Finally, this will all have to be subject to any new or transitional approval regime, given that the EMA may cease to have any jurisdiction in the UK.

All in all, Brexit has placed the UK in a position that arguably is more complex than SPC case law….and that's saying something.

Rob and Catherine