With the world struggling during the pandemic, and the UK and EU also dealing with the impact of Brexit, 2021 was spent mostly in crisis mode. Legal developments in life sciences and healthcare focused on Brexit and COVID-related amendment regulations, often in the form of what felt like legislation patches and quick fixes.
The legislation pipeline in 2022 promises further change, both in the UK and the EU, but we expect to see a shift to a more proactive and considered agenda compared with the largely reactive one of the past year.
This time last year, we predicted the COVID-19 pandemic would accelerate the trend of looking at healthcare in the round. The process got underway last year when the European Commission used the momentum to drive increased European co-operation in this area by announcing the European Health Union initiative. This aims to include cooperation between the EU Member States to improve prevention, treatment, and aftercare for diseases such as cancer.
While not formally part of the European Health Union programme, a similar, if older, EC initiative took a big step forward in 2021: the European Council recently green-lighted a new Regulation that will harmonise rules on health technology assessments (HTAs).
These are the types of evaluation currently undertaken by NICE in the UK: they look at the relative effectiveness of new or existing technologies and their relative cost-effectiveness. HTAs are presently undertaken by competent authorities in the EU Member States and normally underpin the decision about whether the relevant health service will reimburse a medical technology. This area is an exclusive competence of the Member States, although there is some informal co-operation between competent authorities.
This proposed Regulation will introduce:
Under the proposal, Member States would still be responsible for assessing the non-clinical (economic, ethical, social etc) aspects of health technology and pricing and reimbursement. However, the 'clinical assessment' (ie the comparative evaluation of health technology) will be harmonised at Union level. While Member States could choose to delay participation in the joint work until three years after the rules enter into force, it would become mandatory after six years.
The European Parliament is expected to adopt the Regulation at the second reading at the plenary session on 13 to 16 December 2021. The Regulation will then be published in the Official Journal of the European Union and enter into force.
According to the European Parliament Briefing, back in 2019, national parliaments were "divided in their appreciation" of the proposed Regulation, while the pharmaceutical industry criticised it for "lack of ambition". However, this proposal took off in March 2021 and now looks set to become law.
Reform of the pharmaceutical legislation is on the European Commission's work programme for 2022. The aim is to ensure access to quality, safe, efficacious and affordable medicines in the EU, to foster innovation and ensure security of supply.
The Commission also promises to introduce digitalisation of processes and procedures. This reform is part of the pharmaceutical strategy, which is one of the items on the European Health Union agenda.
Other workstreams in the Commission's programme are dedicated to reforming the Supplementary Protection Certificates (SPCs) and the Paediatric Regulation.
The MHRA's consultation on the new post-Brexit regime for medical devices and IVDs ended on 25 November 2021. According to MHRA's timeline, by Spring 2022, we can expect the government's response and secondary legislation for the new UK regulations on medical devices.
The intention is for the new rules to apply from 1 July 2023. This is the date when the UK government has previously said the CE mark would no longer be recognised in Great Britain, and the UKCA mark will become mandatory.
The aim of the consultation is to create:
"...a robust, world-leading regulatory system for medical devices in the UK that prioritises patient safety. A system that:
There is certainly no lack of ambition here. We are particularly keen to see whether the UK regime will manage to get around the notified bodies bottleneck. One obvious solution would be to have a government body to take over certification functions (FDA-style), but the government might also consider making the notified body business model more attractive. With the right incentives, could 2022 be the year when venture capital invests in notified bodies?
In 2021, many companies opted to take advantage of the transitional provisions in the Medical Devices Regulation, but since May 2021, we have started to see what living within the constraints of those transitional provisions really looks like.
The transitional provisions in the MDR are not a 'get out of jail free' card; companies relying on the certificates issued under the previous regime still have to comply with a number of MDR provisions, many of which require adjustment of internal processes.
Now it looks as though the same fate awaits many IVD manufacturers. Following the European Commission's proposal to stagger the transitional periods under IVDR depending on device class, many manufacturers will have no choice but to use transitional provisions. Like those under MDR, these provisions will require compliance with other elements of the new Regulation.
While we are not expecting new legislation in this area, we are anticipating the Medical Devices Co-ordination Group will issue weighty guidance under both Regulations. For those who are caught by it, 2022 may involve a lot of adjustment, possibly on a rolling basis.
To discuss these predictions in more detail, please reach out to a member of our Life Sciences & Healthcare or Technology, Media & Communications teams.
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