This week we look at two developing trends in actions taken by international medicines and medical device regulators in the context of the COVID-19 crisis:
- increasingly joined-up, targeted international efforts to coordinate the approach to the fight against COVID-19 globally; and
- adjustments to special rules and regulations, including those that established export/import restrictions, in relation to PPE and certain other goods amidst the COVID-19 crisis.
As we have seen before in this context, these trends track with the progression of COVID-19 and the importance of specific types of products in that disease lifecycle. For key COVID-19 supplies, the initial approach adopted by many countries was largely to retain stock for local markets as much as possible. We are now seeing this modified in an attempt to strike the right balance between public health needs and securing open trade flows. A more cooperative effort may be useful in respect of some relevant areas that life sciences regulators oversee, for example hand sanitizer and PPE, as immediate stock crises subside but global demand remains high. Similarly, a collaborative effort is required to develop a new vaccine to tackle the virus, as the expertise and facilities required to do this are dispersed amongst different countries around the world.
The response to COVID-19 has seen a growth in international collaboration of medicines and medical device manufacturers and regulators across the globe in recognition that, as borders are reopened, a joined-up effort is likely to be key to success.
As we have discussed in a prior blog, the International Coalition of Medicines Regulatory Authorities (“ICMRA”) published a joint statement pledging to increase global collaboration to tackle the COVID-19 pandemic. The ICMRA is a group of 29 international medicines regulatory agencies, overseen by the World Health Organization as an observer. The group is focused on crisis response, and in that context provides a global strategic focus for medicines regulators and gives strategic leadership on shared regulatory issues and challenges.
Following the publication of its statement (and since our last blog), the ICMRA has held fortnightly strategic meetings between regulators around the world to discuss strategic issues and regulatory approaches.
Key areas for coordination have concerned:
- Regulatory criteria and guidance for the prioritisation of COVID-19 vaccines. It was broadly agreed that multi-centre, multi-arm clinical trials should be prioritised to assist with the rapid assessment and authorisation of COVID-19 treatments.
- The balance between safety and speed in developing COVID-19 treatments. Concerns were raised about the risk that trials may be discontinued too early, and it was acknowledged that whilst rapid development of treatments is required, they must still ensure that sufficient data are obtained to demonstrate safety and efficacy of any treatments.
- The exchange of information regarding extraordinary measures and high-level regulatory flexibilities applied during the pandemic, in particular those regarding virtual evaluations and removing good clinical practice inspections. It was concluded that, following the pandemic, it would be critical to take a converged approach to (a) withdraw the regulatory flexibilities implemented; and (b) assess any benefits of the adaptations.
- A commitment to exchanging and continuously monitoring medical supply chains over the course of the pandemic to prevent shortages around the world.
Export and Import rules
Relaxation of export rules for medical supplies
At the beginning of the COVID-19 crisis, the European Commission introduced a scheme which prohibited the export of certain PPE supplies without an export authorisation. These measures were implemented to ensure continued availability of supplies in local markets for the fight against COVID-19.
The scheme was only drafted to remain in force for 30 days from the 26 April 2020. As no extension measures have been implemented, the scheme expired on 25 May 2020. Therefore, goods exported from the EU are no longer subject to the requirement for an export authorisation.
Access to reliefs for import duty and taxes
A number of countries have implemented import duty or tax reliefs in relation to essential products for COVID-19. For example, the UK has issued updated guidance on claiming relief against import duty and value added tax (VAT) on certain medical supplies, equipment and protective garments imported in response to the COVID-19 crisis. A full list of goods subject to these reliefs can be found here.
This relief applies to the import of such goods on behalf of state organisations and other charitable or approved philanthropic organisations, where such goods are to be donated or sold to the approved organisation on a direct or indirect basis.
The UK guidance has further clarified that where importing goods on behalf of one of the approved organisations, the importer must have in place at the time of importing such goods arrangements to sell or donate the goods to one of the approved organisations. So, it is not sufficient to subsequently declare such an intention.
In all countries where these sort of temporary import duty and tax reliefs exist, clear evidence is required, both to successfully claim the reliefs and in case of any future challenge to a company’s reliance on them. Therefore, it is vital that importers carefully comply with the scope of the temporary measures, seek up to date advice on the applicability of reliefs to their products, and carefully document arrangements prior to the import of relevant goods.