Draft legislation amending the Human Medicines Regulations 2012 (2012 Regulations) and associated Medicines (Products for Human Use) (Fees) Regulations 2016 has been published to ensure they are fit for purpose in a no deal Brexit scenario. They allow the MHRA to function as a standalone regulator in the event of a no-deal Brexit. They also amend the 2012 Regulations to enable regulations to be made to temporarily modify the 2012 Regulations to deal with any serious shortages of medicines arising from the UK’s withdrawal from the EU. The draft legislation will now go to parliament for debate. Please see here for the full text.
The European Medicines Agency has updated its suite of guidance on Brexit. The guidance is written from the premise that the UK will leave the EU on 29 March 2019 without a deal in place. This follows the recent publication by the UK’s MHRA of substantive no-deal guidance and draft legislation to put no-deal measures into effect in such circumstances.
Guidance on marketing authorisations granted through the centralised procedure is updated, and reiterates the importance of ensuring that any centrally authorised MAs (CAPs) held by UK entities must be moved to entities based in the EU-27 by the point of a no-deal Brexit.
There is updated guidance in relation to drugs being evaluated through the mutual recognition and decentralised procedures. This covers the issue of still ongoing or pending applications and gives clarity on how to handle these. Any variations still pending with the UK as RMS will be stopped at the point of Brexit, and will require the RMS to be transferred to the EU-27 before any other variations can be made, post-Brexit.
UK and Australia last week signed a pre-Brexit deal which provides for reciprocal recognition of conformity assessments and certification for medicines and medical devices. The deal is aimed at streamlining export and import processes by eliminating the need, cost and time for testing and certification in the receiving country. The broad scope of the Australia-Britain Mutual Recognition Agreement on Conformity Assessment (MRA) means that if a medicine or medical device has been certified as meeting standards in Australia it is recognised as meeting British standards – and vice versa.
This is an important development for the healthcare sector, in both the UK and Australia, as the deal covers all relevant aspects of the MRA currently in place between the EU and Australia and ensures that these arrangements continue to exist, even if the UK leaves the EU without a deal.
According to Liam Fox, Britain’s Trade Secretary, “This agreement will help give UK and Australian businesses, exporters and consumers the certainty they need to continue trading in confidence as the UK leaves the EU.” Australian High Commissioner George Brandis stated that the MRA “… guarantees continuity of arrangements that have long boosted trade between our two countries.” The MRA, which is composed of one agreement dealing with the manufacturing sector and the other dealing specifically with wines, covers approximately one-third of British goods exports to Australia, and is of particular importance in ensuring the continued smooth flow of British-made pharmaceutical and medical products into Australia.
The MRA was signed on January 18, 2019 and now needs to be formally ratified by the British and Australian parliaments before Brexit.
The plans for minimising the risks and dangers of medicines and medical supplies during a no-deal Brexit are accelerating and being given increased press attention.
The MHRA published a note on 18 January aimed at the UK public, on getting medication in the event of no-deal.
- In the guidance, the MHRA notes that around 75% of the medicines and over 50% of the medical devices and one-use medical products (such as syringes) that the NHS uses, come into the UK via the EU.
- The MHRA states that the government has analysed the supply chain, and given instructions to pharmaceutical companies (and medical devices companies) to ensure they have adequate stocks to cope with any potential delays at the border.
- On 23 August 2018, Matt Hancock, Minister of Health, wrote to pharma companies to request suppliers to (i) increase their medicines stocks by at least 6 weeks on top of their usual buffer stocks; and (ii) ensure plans are in place to air freight products with a short shelf life that cannot be stockpiled.
- On 23 October 2018, the Minister wrote to medical devices companies to request suppliers that source products from other EU countries to review their supply chains and determine what measures they need to take (i.e. including stockpiling) so that they can continue to provide products in the event of a no deal exit.