Laura Reynolds and Xisca Borrás
With less than a month to go before Brexit day, and with no certainty on the terms on which the UK will leave the EU, the UK Government is preparing for a “no-deal” Brexit. While all stakeholders are working to ensure that, as the UK leaves the EU, there is no reduction in patient access to safe and effective medicines, the UK has conceived a system of IP incentives for medicinal products that will apply if the UK leaves the EU and becomes a third country at 11pm GMT on 29 March 2019 without a withdrawal agreement and framework for a future relationship in place. This article summarises this system of IP incentives specific for medicinal products.
2. Regulatory data protection
According to the UK Government’s “Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal”, updated 4 January 2019, the UK will adopt the current EU data and market protection periods after Brexit.
The current intention is that, upon Brexit day, The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 Statutory Instrument (“HM SI”) will come into force. Amongst other things, it includes a new regulation 51 which restates article 10 of Directive 2001/83/EC, as amended (“EU Medicines Directive”), with amendments. The HM SI is currently in draft (here). According to said new regulation 51, after Brexit, data and market exclusivity in the UK will start on the date of authorisation in the UK or EU/EEA, whichever comes first. According to the UK Draft Explanatory Memorandum accompanying the HM SI, “[c]ontinuing to calculate data exclusivity by reference to the first authorisation in the UK or EEA aims to protect UK public health by discouraging delay to innovative products reaching the UK market once the UK is no longer part of the reciprocal and other arrangements for centralised and decentralised MA procedures”.
The UK Government has announced it will carry out a review within 2 years of Brexit in order to make sure the UK remains competitive.
3. Orphan market exclusivity
According to the UK Government’s “Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal”, updated 4 January 2019, after Brexit there will be a UK system for rare disease medicinal products similar to the system in the EU.
The provisions of the Orphan Regulation (Regulation (EC) No 141/2000) are incorporated in the Human Medicines Regulations 2012 (“HMRs”) by way of the HM SI, with appropriate amendments (new regulations 50G, 58C and 58D of the HMRs). In particular, the UK system will have two significant differences:
1) The current pre-marketing authorisation orphan designation (“OD”) will not be replicated in the UK, meaning that the OD assessment will only take place at the stage of the marking authorisation (“MA”) application.
2) Some of the criteria for OD will be UK-specific, that being the prevalence of the condition in the UK, the availability of satisfactory methods of diagnosis, prevention or treatment of the condition in the UK and significant benefit.
The UK Government seeks to replicate the EU system by the introduction of 10 years of market exclusivity during which the competent authority (i.e. the MHRA) cannot accept another application for an MA, or grant an MA or accept an application to extend an existing MA, for the same therapeutic indication, in respect of a similar medicinal product, unless clinically superior. If criteria for OD are met, the 10 years of orphan market exclusivity would be awarded following grant of a UK orphan MA, although the market exclusivity period in the UK would start on the date of first authorisation in the UK or EU/EEA, whichever comes first. According to the UK Draft Explanatory Memorandum accompanying the HM SI, “[t]his is to discourage companies from delaying bringing their innovative products to the UK market once the UK is no longer in the EU medicines regulatory network and is aimed at protecting public health in the UK”.
The UK Government has committed to monitor this incentive and will consider any further evidence to support this.
According to the latest Government guidance (issued 5 February 2019), in the event of a ‘no-deal’ Brexit:
- existing UK SPCs will continue to be valid; and
- pending UK SPC applications and paediatric extensions to such SPCs will continue to be assessed on the same basis as applies at present.
The only impact will be upon new applications for SPCs, or paediatric extensions to SPCs, which are filed after Brexit.
According to earlier Government guidance (issued 24 September 2018) the intention is that the existing system will remain in place, operating independently from the EU regime but with all the current conditions and requirements. This should mean that the existing law in relation to SPCs, including CJEU decisions to date, will be retained in UK law but UK law will then be able to evolve separately post Brexit since the CJEU will no longer have jurisdiction over UK SPCs.
The current intention is that, upon Brexit day, The Patents (Amendment) (EU Exit) Regulations 2018 Statutory Instrument (“IP SI”) will come into force. The IP SI is currently in draft (here) and has been approved by resolutions in the Commons and Lords.
The IP SI amends various aspects of IP legislation and, at Part 8, addresses SPCs for Medicinal Products. In summary, it incorporates and amends the SPC Regulation so that references to the EU Medicines Directive, EU Veterinary Products Directive (Directive 2001/82/EC) and Regulation (EC) No 1901/2006 (“EU Paediatric Regulation”) become references to the corresponding proposed amended UK legislation, which are discussed in this note. References to “marketing authorisation” become references to “UK authorisation”. The key provisions of the SPC Regulation including the Article 1 definitions and Article 3 criteria are unchanged. The term of the SPC will continue to be calculated by reference to the first MA granted in the UK or EU/EEA, whichever is earlier (although the BIA is lobbying for this to be changed – see below).
The only significant changes are:
1) Amended Article 2:
“A product may, under the terms and conditions provided for in this Regulation, be the subject of a certificate if it is—
(a) protected by a patent; and
(b) the subject of a UK authorisation prior to being placed on the market as a medicinal product.”
This contrasts with the position of the CJEU in Synthon v Merz (C-195/09) and Generics v Synaptech (C-427/09), which held that where a product was first authorised anywhere in the EU without having undergone the safety and efficacy testing required under the EU Medicines Directive that product would be outside the scope of the SPC Regulation and could not be the subject of an SPC. Under Amended Article 2 it would appear that, post Brexit, a product will only be excluded (and thus unable to benefit from an SPC) if it was previously placed on the market in the UK without such an authorisation. This was the argument originally made by Merz, that “market” in Article 2 must be interpreted as the market of the Member State for which the SPC application was submitted and in whose territory the patent was valid. Merz had argued that it would be entitled to an SPC in the UK because the product authorised under the national law of Germany and Luxembourg (rather than under the EU Medicines Directive) could not have been placed on the UK market.
2) There are changes to Article 8 dispensing with the need to provide proof of MAs in all other Member States when seeking a paediatric extension, in light of the amendments to paediatric rewards discussed below.
In a press release (dated 7 February 2019) the BIA reported that the Government had committed to further consultation with the BIA on the UK’s future IP rights regime in the event of a ‘no-deal’ Brexit, following concerns raised in the Lords during the debate on the IP SI. From the dispatch box the Rt Hon Lord Henley, Parliamentary Under-Secretary of State at the Department for Business, Energy and Industrial Strategy, provided reassurance that if the IP SI comes into law, it will be a temporary solution, and said that Government is considering options for a future regime and will consult with business. In particular the BIA and the other organisations representing pharmaceutical innovators are seeking to change the legislation so that the term of any new, post-Brexit SPC is calculated by reference to the UK authorisation date rather than the date of the first MA in the EU/EEA on the basis that they may be delayed in obtaining their UK authorisations after Brexit.
5. Paediatric rewards
According to the UK Government’s “Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal”, updated 4 January 2019, the MHRA will take decisions on paediatric matters after Brexit.
The HM SI provides for a UK based system, and the provisions of the EU Paediatric Regulation are incorporated in the HMRs with appropriate amendments (new regulations 50A to 50F, 58A and 58B and 78A of the HMRs).
In this regard, compliance with a UK paediatric investigation plan (“PIP”) (or deferral or waiver) should be demonstrated in applications for new medicinal products, as well as in new indications, new routes of administration, and new pharmaceutical forms for all products protected by an SPC or by a patent which qualifies for the granting of an SPC.
The same rewards for PIP compliance will be available in the UK after Brexit:
1) A six-month extension of a UK SPC; or
2) Two years of additional market exclusivity for orphan medicines.
Amongst the amendments made to the current EU system, the existing requirement that the product is authorised in all Member States for applications for a six-month extension of an SPC is abolished for applications filed after Brexit.
6. Paediatric use marketing authorisation (PUMA)
Article 30 of the EU Paediatric Regulation on PUMAs is implemented in the HMRs by way of the HM SI, with appropriate amendments (see new regulation 50E and 58A of the HMRs). After Brexit the holder of a UK PUMA will be entitled to benefit from data and marketing exclusivity starting on the date of authorisation in the UK or EU/EEA, whichever comes first, in relation to the material supplied to the licensing authority necessary to establish the quality, safety and efficacy of the product in the paediatric population, including any specific data needed to support an appropriate strength, pharmaceutical form or route of administration for the product, in accordance with an agreed PIP.