In such unprecedented times, international product regulators are finding themselves under increasing pressure and seem to be reacting with a previously unseen level of agility and flexibility. We look at what is happening, globally. Is it business as usual? What are we seeing them focus on? And what does this mean for the future of products regulations?
In the face of the COVID-19 crisis, we have taken a global look at how international products regulators have reacted to this unprecedented situation and the pressures it brings. With massive thanks to all our contacts who have provided insight and commentary, and following on from the webinar we held with Rod Freeman (Cooley's International Products Head, London), Matt Howsare (Cooley's North America Products Chair, Washington DC) and Sylvie Gallage-Alwis (Partner, Signature Litigation, Paris), we look at whether international product regulators are still operating; what they are focusing on; and what this might mean for the future of product regulation.
We should add that this is correct at the time of writing, but this is a constantly evolving picture – please contact us if you would like to check whether any of the below is still the current position.
Are they still operating?
In a word, "yes". In two words, "surprisingly so". And in a few more words, we are seeing a lot of activity! None of the international product regulators appear to have shut down entirely, many are working effectively remotely, and we are seeing a range of responses start to emerge. By way of snapshot:
- In several countries, like the UK, Norway, Ireland and the UAE, regulatory staff are aiming for "business as usual" and there are signs that they are no less active. By fully embracing remote working technology, they are seeking to discharge their everyday functions. As a result, we are still seeing product recalls announced and receiving inquiries from regulators about ongoing matters.
- In North America, the ability of regulators to perform lab-based technical analysis has been slowed and the regulators appear to be prioritising the more important safety cases. The regulators are still very much emphasising the need to comply with their reporting requirements and are arguably more accessible due to fewer scheduled meetings.
- Places like Japan, Mexico, Austria and New Zealand are still fully operational on the product regulatory front. Japan in particular does not seem to have any appetite for relaxing reporting requirements.
- In other jurisdictions, such as Russia, we understand that some normal product regulator activities are expected to slow, as a result of remote working requirements.
- For countries coming out on the other side, like China and Hong Kong, regulatory staff are returning to work but we can expect they will be starting to deal with a backlog of cases and are not yet up to full speed. Additionally, for any countries that have made it through, there is still a new risk of the virus re-entering from Europe or the US, which may cause further instability in a recently stabilised situation.
Realistically though, despite best intentions, we anticipate that even the more sophisticated operators will experience some delays in progressing matters. Particularly as their focus shifts to COVID-19 matters (more of which, below) and also looking more long term to policy issues (also more of which, below).
What are they focussing on?
The pandemic is causing major issues around shortage of supply of vital products. Products like personal protection equipment, aka PPE, to protect healthcare workers; hand sanitizers to help prevent the spread of the virus; or products which help those who are very unwell to breathe, like ventilators or CPAP machines. These are just a few of the "products" which are critical to the fight against coronavirus and which are regulated by our products regulators. They are also the products which market is crying out.
With this in mind, product regulators find themselves in a precarious position of finding a way to allow more products to market to meet supply (and the great news is that we are seeing many manufacturers volunteer themselves to try and meet that supply issue), whilst trying to maintain high safety standards which sometimes entail slow certification or authorisation processes. It is no good allowing substandard PPE to market to meet an instant need, if that fails to provide adequate protection to the healthcare workers using it. But arguably of equal no good is refusing a product entry to market which is technically safe but simply missing a label, or which is demonstrating in early testing high levels of efficacy, in these extraordinary times of pandemic.
So despite several regulators declaring business as usual, there can be no doubt that we have seen a global shift in focus towards COVID-19 issues whilst they try and tackle these urgent and critical issues. However, the nature of those shifts has varied and we are seeing a mixed story:
- In the EC recommendations have been made for member states to put in place expedited procedures for approving the manufacture of PPE more quickly, and allowing Member State autonomy in certain situations.
- Spain has sought to enact those recommendations. The Belgian government has set up a temporary task force to develop immediate solutions to a national shortage of PPE and medical equipment, but has prohibited facemasks imported from the UK to be used in hospitals because of missing certifications.
- In Poland and Taiwan, they have brought in emergency laws to prevent or limit the export of certain key products, such as medical devices and PPE.
- The French regulator is taking a strict approach, with March being its busiest month of published recalls in 2020. They have also warned companies it will impose sanctions for unreasonably increasing the prices of PPE, as well as for attempting to put non-compliant PPE items on the market.
- China has seen no relaxation of regulatory measures. On the contrary, the product regulator is more stringent than ever in its review of products intended for the domestic market, in light of health and safety risks arising out of the COVID-19 crisis.
- In Singapore, the product regulator is enhancing its monitoring of consumer scams and any excessive profiteering situations arising out of the coronavirus crisis.
- Similarly, in the Netherlands and Australia, the product regulator has issued notices to the public warning against scams and "fake" products that purport to protect against the virus.
- Canada has lifted regulatory requirements around the supply of certain products and services, including food, dry goods and grocery-related delivery services.
- Similarly, Thailand has created favourable conditions for production, imports and exports.
As a general observation, we think overall that product regulators have moved quickly on these issues and adapted with a greater ease than previously seen. For many years we have heard that regulation has been unable to keep pace with the development of products, but in the face of a crisis, we are seeing regulators adapt and react with admirable speed.
The reality though, is that to allow product regulators the bandwidth to consider COVID-19 measures, something needs to give. Our prediction is that this will be the longer-term pieces such as policy reform, major legislative reviews and enactments unless these are very advanced. Right now, it feels as if the world has enough of its plate, including product regulators, and the policy piece may need to take a back seat.
What does this mean for the future?
This last month has seen an increasing number of regulators adopt a more proactive, and more flexible approach to product regulation, it's a new type of agility that we've not seen before. But is this here to stay? Our view, is that if (when) we return to the world before, then any relaxations will most likely revert. Some countries have specifically time-limited relaxations to ensure they are temporary. And it would be difficult to expect regulators to keep moving at such a speed without a crisis as impetus to do so. But we do wonder if there is scope for the spirit of agility and flexibility to remain, we certainly hope it will, based on lessons learned from the current crisis.
This is also a good argument in support of the push for more standards being fully global. PPE manufactured to a global, not regional standard, could have helped ease some supply issues. There are of course important counter arguments to global standards which we will leave for discussion at another time.
We also envisage that there will be a catch up period, where we try to get back to normal. There will be initial delays and bottle necks which will need to work through.
And finally, we are continuing to watch the impact on policy development more generally. Similarly there will be a catch up period for this too, whilst we see things get back on track. But we also wonder if some of the lessons that we hope are learned from this truly global crisis, might cause changes of tack in future products policy. Perhaps certain issues will become no longer important, whilst others will be increasingly so.
We are continuously checking in with our network of expert local counsel around the world, and are working with them to monitor the international product regulatory responses for updates.
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