05 th Sep Pharma on BREXIT – from gloomy to optimistic
Pharma on BREXIT – from gloomy to optimistic
For pharmaceutical companies with interests based in the UK, consideration of Brexit can seem a gloomy subject. After all, businesses do of course have to consider the worst in order to plan. A recent position paper released by the ‘Department for Exiting the European Union’, titled ‘Continuity in the availability of goods for the EU and the UK’, gives pharmaceuticals companies more cause for optimism. Whilst politicians talk tough, the paper is of a more reconciliatory tone, calling for a future of cooperation and mutual recognition between the UK and Europe.
The position paper lays out 4 principles:
– Principle A: Goods placed on the Single Market before exit should continue to circulate freely in the UK and the EU, without additional requirements or restrictions.
– Principle B: Where businesses have undertaken compliance activities prior to exit, they should not be required to duplicate these activities
– Principle C: The agreement should facilitate the continued oversight of goods
– Principle D: 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.
Whilst the paper is not exclusively targeted at the pharmaceutical industry, the department obviously had the sector in mind with a great deal of its content. For example, principle B includes discussion regarding the role and location of the Qualified Person for testing and batch release of medicines. The paper states that the UK wants to avoid an unnecessary disruptive transfer of activities between the EU and the UK, and these ongoing activities being duplicated for both markets.
The paper proposes that the authority and business should be able to continue to carry out ongoing functions for relevant products or types of products for both UK and EU markets and this activity can take place in their location as at the date of withdrawal. This would mean that UK manufacturing sites could still release products for EU countries and there would be no requirement for QPs or Marketing Authorisation Holders to relocate from the UK to the EU or vice versa.
Under principle B and then continued in the discussion under principle C, the paper proposes that “where there are ongoing obligations for the assessment bodies after the product has been assessed, the UK proposes that bodies should continue to fulfil any ongoing obligations for the product life-time”. This could be interpreted as the UK would be willing to continue to act as the Reference Member State for products already registered under the centralized procedure.
Principle B also proposes that the schedule for inspection of manufacturing facilities should continue as planned with no requirement to re-inspect following exit.
Principle A further proposes that no changes are required to products already on the market in the UK and EU. In particular, labelling, approvals, authorisations and the location of the Responsible Person for cosmetics or the Authorised Representative for Medical Devices should remain unchanged following market exit. Presumably this principle would also be proposed to extend to the qualified person responsible for pharmacovigilance (QPPV). Market oversight, including the requirements on market authorisation holders to report adverse reactions to medicines, is touched on again in Principle C, though with no detail is given beyond the overarching principle of cooperation and mutual recognition.
In June 2017, the MHRA sent a consultation to pharmaceutical companies in the UK. This consultation requested information regarding additional costs that would be incurred in the scenario where there was no cooperation between the UK and Europe following Brexit. The consultation had focused on 3 particular fields:
– Batch testing duplication
– Additional licensing requirements
– GMP Inspection duplication
This position paper clearly aims to reassure some of the concerns that have been voiced by pharmaceutical companies in the UK. The final extent of the cooperation and mutual recognition will be dependent on the long exit negotiations. This paper however, is at least an indication that the UK government has listened to the concerns and is dedicated to resolve them in the most cost-efficient way for businesses, whilst keeping pharmaceutical jobs in the UK.