Article by Harry Taylor
The UK Government recently published a Brexit negotiations position paper which will be of particular interest to the life sciences sector.
The paper, entitled ‘Continuity in the availability of goods for the EU and the UK’, sets out four principles underpinning the Government’s negotiating strategy in this area:
- Goods placed on the Single Market before exit should continue to circulate freely in the UK and the EU, without additional requirements or restrictions;
- Where businesses have undertaken compliance activities prior to exit, they should not be required to duplicate these activities;
- The agreement should facilitate the continued oversight of goods; and
- Where the goods are supplied with services, there should be no restriction to the provision of these services that could undermine the agreement on goods.
Life sciences highlights
The life sciences topics alluded to in the paper focus on regulation. The UK government is keen to ensure that “any approvals, registrations, certificates and authorisations issued by a third party … prior to exit should continue to be recognised as valid by both markets”. The paper goes on to note that approvals should be valid for the time period intended at the point of approval being granted, “to avoid the need for retesting of products”.
This approach – focussing on minimising disruption and providing as much certainty as possible for businesses – will certainly be welcomed by the life sciences sector.
The paper recognises that the compliance hoops through which businesses must jump in preparation for putting goods on the market are “complex, lengthy and often costly”. A specific example given is the requirement for businesses selling chemical substances to collect and submit data on the hazards and risks of such substances.
The UK government wants to ensure that the validity of this pre-Brexit compliance activity remains recognised after Brexit, “regardless of where the activity took place”. The paper again notes that this activity “should be recognised for the full time period or type of products intended when the compliance activity was undertaken”.
The requirement imposed on market authorisation holders to report adverse reactions to medicines is singled out in the paper as a matter that the UK-EU Withdrawal Agreement will need to address. The Government’s position is that “clarity” is required on how activities such as this will be conducted post-Brexit, and that the solution reached must afford both the UK and the EU “confidence” in the competence of the body to which such adverse reaction reports will be made.
The industry’s response to the paper has been broadly positive. Dr Virginia Acha, executive director of the Association of the British Pharmaceutical Industry (ABPI), and Steve Bates, chief executive of the BioIndustry Association (BIA), released a joint statement welcoming the paper’s “pragmatic approach” as a “constructive starting point”.
The paper sets out the UK’s optimal outcome from the ongoing negotiations surrounding goods. Until substantive progress is made, discussions of a best-case-scenario outcome will not assuage the life sciences industry’s concerns about the regulatory uncertainty ahead. However, the paper will at least give some solace to the industry in setting out the Government’s desire to avoid Brexit-based disruption as far as possible.