Is the European Union Trying to Get Round its Own Rules on Batch Testing?
Many in the pharma sector had wanted closer ties and mutual recognition between the UK and EU in the Trade and Co-Operation Agreement.
Whilst the deal covers good manufacturing practice and the mutual recognition of inspections by the national regulators (the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA)), there are notable areas that are not covered, which include:
- mutual regulatory authority recognition or equivalence,
- mutual recognition of batch testing,
- mutual recognition of Good Clinical Practice, and
- information sharing and packaging, labelling and other aspects of regulations on falsified medicines.
It is to be hoped that the UK and EU will strive to agree to this for the good of patients. If the EMA had recognised the MHRA's incredible coronavirus (COVID-19) vaccine regulatory approvals, that could have helped many EU citizens. With this not having happened, the roll-out of vaccines in the EU has suffered. There will no doubt be other examples in the other direction. Why shouldn't two highly respected regulatory agencies with such a rich history continue to be able to work together closely for everyone's benefit? This is so important when patients' lives are at stake.
Meanwhile, the lack of recognition by the EU of UK Qualified Persons to certify the release of batches of medicines, when they were recognised as capable of doing so until 31 December last year, also makes little sense and can impact on the supply of medicines. EU Directive 2001/83/EC requires testing of every batch of products manufactured in the EU or imported into the EU. It does not need to be tested a second time if there is a mutual recognition agreement in place - for example, as exists between the EU and Switzerland. As the EU and the UK do not have a mutual recognition agreement in place, this means doubling up on this important function, increasing cost and slowing down the supply of medicines.
It was therefore surprising to read Section 5.4 of the Advance Purchase Agreement between the European Commission and AstraZeneca for the COVID-19 vaccine (the APA), which the Commission has published. That provision seems to enable the Commission to not be subject to the same rules when it is buying the products.
The wording in Section 5.4 of the APA says as follows: "AstraZeneca shall use its Best Reasonable Efforts to manufacture the Vaccine at manufacturing sites located within the EU (which, for the purpose of this Section 5.4 only shall include the United Kingdom) and may manufacture the Vaccine in non-EU facilities, if appropriate, to accelerate the supply of the Vaccine in Europe…"
The obvious question is: why did Section 5.4 not refer to the manufacture of the Vaccine at manufacturing sites located "within the EU or the UK"? Why deem the UK to be part of the EU for the purpose of manufacture? This would be a strange choice of words, unless it was accepted that some of AstraZenica's manufacture would take place in the UK - and the Commission did not want to have the additional time and cost of additional batch testing.
It would be good to see closer mutual recognition to enhance treatment for patients by returning to the position where both the UK's and EU's Qualified Persons are trusted and the UK's and EU's medicine regulators can work together for the good of all. After all, if it was good enough for the European Commission in the APA to agree to circumvent the requirement to have batch testing done in the EU when it takes place in the UK, then surely this is important to happen for other medicine supplies.