BIA welcomes Minister’s Reassurance on the Patents (Amendment) (EU Exit) Regulations 2018

The Government last night committed to further consultation with the BIA on the UK’s future Intellectual Property rights regime in the event of a ‘no deal’ Brexit following concerns raised in the House of Lords. 

The Patents (Amendment) (EU Exit) Regulations 2018, along with other intellectual property related regulations, returned to the House of Lords on 6 February – after previously being “negatived” by the House of Lords Grand Committee.  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 they come into law, the “no deal” Statutory Instruments (SIs) are a temporary solution, and that Government is considering options for a future regime and will consult with business.  Following debate the SI was agreed by the House of Lords.

Lord Henley stated that if there is a no deal Brexit that Government will immediately start to explore the future landscape with the sector.  He stated that this will include discussion on SPC term, and Government had already committed to review this within two years.

Lord Henley stated that: “I have held further helpful and constructive meetings with the BioIndustry Association and the ABPI. Let me make it clear that I value those regular contacts and the insight that they bring on behalf of this important industry. I will continue to have discussions with representatives from industry and hear their perspectives as we move forward.

"The BIA and the other organisations representing pharmaceutical innovators would prefer the legislation to be changed so that the term of an SPC would be calculated based on only a UK market authorisation. They argue that the exit may lead to industry launching new pharmaceutical products later in the UK and that they may receive later market authorisation than in the rest of the EEA.”

BIA had raised concerns that the regulation sends a signal globally that UK Government may not be fully committed to a gold standard intellectual property regime, and that it will in turn impact the attractiveness of the UK as a location for international investment.  BIA is also concerned about the lack of formal stakeholder consultation on the regulation.  At the Grand Committee on 14 January, Lord Warner highlighted our concerns to the House and the Minister. 

As the number of SIs being laid in preparation for a ‘no deal’ Brexit increases it is essential that Government considers the impact that they may have on patients, businesses and investors so that the UK continues to be a global leader for the life sciences sector.

Steve Bates OBE, CEO of the BIA said:

“Our members will welcome the Minister’s assurance that this Statutory Instrument (SI) is a temporary solution and that in a ‘no deal’ Brexit they will immediately start to consider the future landscape with stakeholders.  It is essential that, if there is a ‘no deal’ Brexit and this regulation comes to be, that there is an immediate formal stakeholder consultation – and BIA stands ready to assist.

 “While our sector is currently thriving - it has much to lose. Maintaining a strong intellectual property framework is essential if the UK wishes to have long-term sustained investment in R&D and remain a globally-attractive location for international investment. Any signals that the UK may not offer the same patent protection after Brexit will adversely impact the global reputation of the UK as a location for the life sciences industry.”

In regard to government’s no deal parliamentary programme, Steve said:

“We were concerned at the rushed nature of this and other SIs and in particular the adverse signals that they are sending globally”

Notes to Editors 

1. BioIndustry Association (BIA) has concerns about both the impact and process of the Patents (Amendment) (EU Exit) Regulations 2018, specifically Article 3 “Conditions for obtaining a certificate 55”, which states that “(2) (v) the number and date of the earliest of any EEA authorisation, the granting of which predates the granting of the UK authorisation.”  
2. Article 3 refers to Supplementary Patent Certificates (SPCs), which are extensions for patents of medicines that provide additional patent life to compensate for the period of market exclusivity lost during the essential regulatory approval process.  Article 3 would maintain the EEA-wide stipulation for UK SPCs despite the medicine covered by the SPC being subject only to a UK Market Authorisation (i.e. it couldn’t be marketed in the UK until approval by the UK-based MHRA). This would have the SPC’s duration aligned with those granted elsewhere in Europe on the basis of first authorisation in the UK/EEA (i.e. even if the UK authorisation was later).  In a no deal reality it is therefore likely that patent protection will be reduced for companies that launch new products in the UK.
3. The first debate on the Patent (Amendment) (EU Exit) Regulations 2018 was considered by the Grand Committee on the 14 January 2019. A full transcript of the debate can be found here.
    
4. The BIA published Confident capital: backing UK biotech that showed that the UK biotech sector raised a record £2.2 billion from investors in 2018. This is almost double that raised in 2017.  It confirms the UK remains the leading life sciences cluster in Europe and continues to challenge cluster in California and Massachusetts.
    

   Contact: Jack Fellows, BIA Communications Manager [email protected] 02076302196

   About the UK BioIndustry Association (BIA)
   Established over 25 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives. For further information, please go to www.bioindustry.org and twitter.com/BIA_UK