EU-UK Trade and Cooperation Agreement

On Thursday 24 December 2020, the EU and UK agreed a future trade and cooperation agreement. This page analyses what the trade deal has to say about medicinal products. 


Main body of agreement

The agreement creates a Working Group on Medicinal Products under the supervision of the Trade Specialised Committee on Technical Barriers to Trade. This will oversee the working of the medicinal products annex.

The agreement leaves open the opportunity for the UK to continue to participate in Horizon 2020 or Horizon Europe. A separate document, the Joint Declaration on Participation in Union Programmes, makes clear that the UK will join Horizon Europe. Horizon Europe should launch in March/April 2021. However, we note that UK SMEs will not be able to access blended finance support (equity and loans) from the European Innovation Funding Council (which is part of Horizon Europe) and understand this was a UK Government decision not to seek it. This, combined with the UK’s decision not to participate in the European Investment Bank and associated Fund, raises concerns about threats to the availability of equity finance for UK SMEs. The British Business Bank, which provides equity and loans to SMEs, should receive increased funds to address the potential shortfall.   

There is a section on patents that is worth a quick look on page 136. It establishes that the WTO TRIPS (Trade related aspects of intellectual property rights) applies. Article IP.33 refers to supplementary protection certificates, although leaves the detail to each individual party.

Article IP.35 relates to the ‘protection of data submitted to obtain an authorisation to put a medicinal product on the market. It says each party must protect commercially confidential information, and outlines the market authorisation holder’s exclusivity rights.

Road haulage operators will now require a licence to transport goods between parties. Medicinal products for emergency relief, including natural disasters and humanitarian assistance, do not require a haulier licence. This could arguably be relevant to medicinal product supplies during the pandemic.


Medicinal products annex

The final agreement includes a medicinal products annex (TbT-2 on page 492). During earlier negotiations, the UK published a draft medical products annex (5-D on page 55) which was more comprehensive. Comparing the draft annex with the final annex gives us an idea of what the EU and UK failed to agree.




eliminate and prevent any non-tariff barriers to bilateral trade;

to facilitate the availability of medicines in each Party’s territory;

reinforce competitive market conditions based on principles of openness, nondiscrimination and transparency;

to set out the conditions for the recognition of inspections and for the exchange and acceptance of official GMP documents between the Parties;

promote public health by safeguarding patient safety and animal health and welfare, as well as protecting high levels of consumer and environmental protection where relevant;

to promote public health by safeguarding patient safety and animal health and welfare, as well as to protect high levels of consumer and environmental protection, where relevant, by promoting regulatory approaches in line with the relevant international standards.

promote compatibility and convergence of regulations based on international standards;


maintain cooperation to foster continued mutually beneficial development in trade


We can see that the UK’s draft annex was a lot broader with reference to eliminating non-tariff barriers, promoting trade and promoting competition. The final annex was a lot more specific. But both refer to promoting public health and promoting approaches in line with relevant international standards.

What the medicinal products annex includes

  • Mutual recognition of GMP certificiates, documents and inspections: However, the final annex adds an additional paragraph setting out how ‘a party may in specific circumstances opt not to accept an official GMP document issued by an authority of the other Party… Each party may determine the terms under which it accepts official GMP documents.’ We can likely expect further guidance on this.
  • Pre-approval inspections and safeguards: The final annex gives each party the right to conduct its own ‘inspection’ of manufacturing facilities that have been certified as compliant by the other party. The word ‘inspection’ likely includes both pre-approval and GMP inspection. This goes further than the draft annex, which only allowed each party to request the other party conducts a GMP inspection of a facility. 
  • Working Group on Medicinal Products: The final agreement established a Working Group to discuss any matters arising under the annex.
  • International standards: This makes clear that the standards for medicinal products should be in line with WHO, OECD, ICH and VICH guidelines.
  • Changes to applicable law and regulations: This enshrines a duty for each party to notify the other at least 60 days prior to adopting any new measures to changes relating to GMP.
  • Suspension: This gives parties the right to suspend (totally or partially) the recognition of inspections and acceptance of GMP from the other party. If any suspension takes place then it should be discussed through the Working Group.
  • Amendments to appendices: This gives the Partnership Council (the forum overseeing the whole agreement) the ability to amend Appendix A which is the list of authorities, Appendix B which is the list of applicable laws and regulations and technical guidelines, and Appendix C which is the list of covered products.
  • Non-application of dispute settlement: This makes clear that Title 1 of Part Six of the agreement does not apply here. This is the dispute settlement agreement that covers any divergence in standards.


What the medicinal products annex does not include

  • Regulatory authority recognition/equivalence: The final deal does not include regulatory authority equivalence or recognition, it only includes ‘regulatory cooperation’ which relates to ‘significant changes to technical regulations or inspection procedures’. It also speaks about cooperation ‘promoting the adoption and implementation of internationally agreed scientific of technical guidelines’.
  • Mutual recognition of batch testing: There is no mention of mutual recognition of batch testing in the final annex. For some reason this was a red line for the EU. We understand this may be because the EU believed that forcing batch testing to take place in the EU will encourage greater medicinal products manufacturing in the EU. There is still an opportunity to push for a mutual recognition agreement outside of the FTA.
  • Two-way alert program and information sharing: It appears there is no regulatory information sharing between the party’s regulatory authorities. This includes pharmacovigilance information sharing, the word ‘pharmacovigilance’ is not included in the final annex.
  • Confidentiality: This is not included in the final annex. The draft annex included an article to ensure that confidential information, including trade secrets and proprietary information, was not shared publicly unless it was deemed necessary to protect public health and safety.