On 27 November 2020, the House of Lords is due to debate the draft Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020. The instrument was laid under the draft affirmative procedure. It must be approved by both Houses before it can be brought into force.

What is a Supplementary Protection Certificate?

Supplementary Protection Certificates (SPCs) are an intellectual property right. They extend the rights and protections previously given to a product by a patent for up to five years after the patent has expired. SPCs are used for medicinal and agrochemical products, to compensate for the time taken between the granting of a patent and the product being sold on the market, due to the lengthy approval process that must take place.

SPCs are currently provided by European legislation in the UK, but they operate as individual national rights in each EU country.

In order to be granted a SPC, a product must have:

  • a patent; and
  • a marketing authorisation (regulatory approval for the product which allows it to be sold in the UK).

What do the regulations do?

The regulations amend the existing SPC system to make it compatible with the Northern Ireland/Ireland Protocol. Under the Northern Ireland/Ireland Protocol, certain pieces of EU legislation will continue to apply to Northern Ireland after the end of the transition period. These include regulations on:

  • veterinary medicinal products;
  • medicinal products for human use;
  • medicinal products for paediatric use; and
  • plant protection products.

In order to obtain an SPC for products to be sold in Northern Ireland, the marketing authorisation must continue to be granted under EU law.

Currently, marketing authorisations are granted on a UK-wide basis. The draft regulations change the current marketing authorisation process to allow authorisations to be given for Northern Ireland only, granted under EU law, or for Great Britain only, granted under UK law.

The explanatory memorandum provided by the Government states that SPCs will remain a UK-wide right, but the protections given under the SPC will only apply to the area specified by the marketing authorisation. The memorandum goes onto explain that:

That does not mean that the territory where protection applies is fixed at the point of applying for the SPC. The protection can be extended further if an authorisation for that product has been granted covering a different part of the UK, and the Intellectual Property Office is notified of it. This can be done either when making the initial application, if all the authorisations have been granted at that time, or at any time before the SPC comes into effect.

What parliamentary scrutiny has taken place?

The regulations have been considered by the House of Lords Secondary Legislation Scrutiny Committee and the Joint Committee on Statutory Instruments. Neither committee drew them to the attention of the House.

A delegated legislation committee considered the regulations on 19 November 2020. During the debate, Chi Onwurah, Shadow Minister for Business, Energy and Industrial Strategy, stated that the Labour Party would not oppose the SI but did raise concerns about the implications of the regulations:

My understanding—this follows on from my first question, and I discussed it briefly with the Intellectual Property Office as well—is that the draft statutory instrument could lead to drugs and agricultural products being available in Northern Ireland under different conditions and circumstances from Great Britain, in terms of whether they can be reproduced or generic equivalents can be sold.

In response to this issue, Amanda Solloway, Parliamentary Under Secretary of State for Business, Energy and Industrial Strategy said:

On whether an SPC that provides protection only in Northern Ireland might allow a company to sell a generic product in Great Britain, in most cases we expect pharmaceutical companies to file for authorisations across the UK so that their SPC protection is UK-wide. However, where an SPC provides protection not only in part of the UK—say, Northern Ireland—it could not be used to prevent manufacture or sale of the drug in GB. Other forms of IP protection such as data and market exclusivity might still apply in GB, and any generic medicine would need to be authorised in its own right before it could be sold.

The House of Commons formally approved the instrument on 23 November 2020.

Cover image by Kendal on Unsplash.