The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations deal with matters arising out of the Protocol on Ireland/Northern Ireland (“Protocol”) in the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 19 October 2019. Union law which applies to the United Kingdom in respect of Northern Ireland under Article 5(4) of the Protocol includes the following EU Directives and Regulations on medicinal products and plant protection products in paragraphs 20 and 24 of Annex 2 to the Protocol:

• Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L311, 28.11.2001, p.1);

• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L311, 28.11.2001, p.67);

• Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (OJ L378, 27.12.2006, p.1);

• Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (OJ L309, 24.11.2009, p.1).

The grant of a supplementary protection certificate in relation to these products may be dependent on marketing authorisations provided under these Directives and Regulations.

Regulations 2 and 3 amend the Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801) in relation to supplementary protection certificates for medicinal products and plant protection products. The Patents (Amendment) (EU Exit) Regulations 2019 come into force on IP completion day. The changes made by these Regulations to the Patents (Amendment) EU Exit Regulations come into effect prior to IP completion day (Regulation 1(2)).

Regulation 4 and Part 1 of the Schedule amend 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.

Regulation 5 and Part 2 of the Schedule amend 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.

Regulation 6 amends the Patents Rules 2007 (S.I. 2007/3291) to provide for a new form to notify the comptroller of any authorisations granted after submission of an application for a supplementary protection certificate. This change is effected by amending regulation 42 of the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050).

Regulation 7 provides for transitional provisions.

Regulations 4 to 7 come into force on IP completion day.

Paragraph 2 of Part 1 of the Schedule amends Article 1 of Regulation (EC) No 1610/96 and paragraph 11 of Part 2 of the Schedule amends Article 1 of Regulation (EC) No 469/2009 to introduce new definitions of “GB authorisation” and “NI authorisation”. A “GB authorisation” covers the territory of Great Britain (England and Wales and Scotland) and a NI authorisation covers the territory of Northern Ireland.

Paragraph 4 of Part 1 of the Schedule amends Article 5 of Regulation (EC) No 1610/96 and paragraph 13 of Part 2 of the Schedule amends Article 5 of Regulation (EC) No 469/2009 to provide that the protection conferred by a certificate extends only to the territory in respect of which a valid marketing authorisation has been granted.

Paragraph 7 of Part 1 of the Schedule inserts a new Article 13A in Regulation (EC) No 1610/96 and paragraph 19 of Part 2 of the Schedule inserts a new Article 13A in Regulation (EC) No 469/2009. These provisions deal with the situation where a marketing authorisation has been applied for or granted in respect of e.g. Great Britain (GB), and a later authorisation is applied for or granted for Northern Ireland (NI). In these circumstances, the comptroller must be notified of the later authorisation so that this may be published.

Paragraph 19 of Part 2 of the Schedule also inserts a new Article 13B in Regulation (EC) No 469/2009 to deal with extensions of the duration of certificates granted in respect of paediatric uses of medicinal products. An extension of the duration of a certificate in respect of a GB authorisation is extended, in certain circumstances, to include Northern Ireland and vice versa the extension of the duration of a certificate in respect of a NI authorisation is extended to include Great Britain.

The changes made by these Regulations supplement other changes made to UK law in relation to supplementary protection certificates by Parts 6 and 8 of the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 which come into force on IP completion day.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public and voluntary sectors is foreseen.

An explanatory memorandum is available alongside this instrument on the Legislation UK website at www.legislation.gov.uk.