Annabelle Bruyndonckx, Counsel and Vladimir Murovec, Supervising Associate
Annabelle specialises in regulatory and compliance advice on behalf of medical technology and digital health businesses, pharmaceutical and consumer health companies and significant players in other highly regulated industries.
Annabelle advises on a wide range of issues from the R&D phase and product qualification/classification, to (early) market access (pricing and reimbursement) and (pharmaco) vigilance, covering all aspects relating to distribution, advertising, tendering and liability issues. Annabelle frequently liaises with Belgian/EU regulators and industry associations on behalf of industry players.
In healthcare compliance, Annabelle has significant experience in local and global cross-border projects, approval and transparency procedures, SOP implementation, and bribery/anti-gift measures.
Annabelle joined Simmons & Simmons in 2013, after more than 14 years at another international law firm, where she headed the Pharmaceuticals & Healthcare group. She has been a part time lecturer at the Catholic University of Louvain from 1997 to 2003.
Annabelle is member of the European Food Law Association, the steering committee of healthy measures (Science Business) and the Belgian Regulatory Affairs Society (BRAS) where she is also a board member and the President of the Education Group organising training sessions for BRAS members. She is frequently invited to speak at international conferences and has published numerous articles in legal and trade journals relating to regulatory matters.
Vladimir specialises in regulatory and compliance advice on behalf of medical technology and digital health businesses, pharmaceutical and consumer health companies, and significant players in other highly regulated industries.
He advises on a wide range of issues from the R&D phase and product qualification / classification, to (early) market access and vigilance / pharmacovigilance, covering all aspects relating to distribution and import-export, marketing and product information, and labelling of regulated products. He frequently liaises with Belgian and EU regulators and industry associations on behalf of industry players.
Vladimir assists Healthcare & Life Sciences companies on the digital aspects of their businesses, from the early development of e-health solutions up until digital and D2C marketing tools and advertising strategies.
In healthcare compliance, Vladimir has significant experience in local and global cross-border projects, approval and transparency procedures, SOP implementation, and bribery/anti-gift measures. He has been seconded to several Compliance departments within Healthcare & Life Sciences businesses, covering EMEA and Benelux.
Not only European guidance but also within each country. There are new laws and guidance being released constantly.
For example, shortage is a big issue right now. A country could ban certain exports and restrict certain distribution channels, but these laws can change from one day to another. So, it’s important at this point in time to just keep on top of the changes at both the local and industry level.
We have found that when we are giving advice, we are needing to refine and change that advice a few days later because of the constant change in regulation. The law is evolving quickly and we need to take into account that these interim measures are in exceptional circumstances. However, some of these measures will have an end date, so it’s imperative to be aware of the daily changes.
This is a big concern, as some specific drugs and active pharmaceutical ingredients (API) are lacking to fight COVID-19. This is resulting in purchasing restrictions on global drugs like paracetamol. Many measures like purchase restrictions are being updated and created to manage this shortage. So, clients need to be in direct contact with their distributors or manufacturers to see what the status is, what ingredients and drugs they have and what they don’t.
Regarding the problems linked to the supply of oxygen in due time of, for example, we have been assisting on the creation of a platform that will help supply oxygen and allocate it to hospitals and care institutions in a more systematic and appropriate way in the current climate – with a ticket system. We can see that there is a clear reorganisation of the market. However, with these concerns and innovations has come a higher level of interaction between competent authorities and pharmaceutical companies that provide these products, because distribution is being monitored day-to-day to ensure there is enough supply in care centres and hospitals. The advice we would give to our clients regarding this shortage, and management of supply, would be to increase their contact with the authorities. They are doing a great job of responding to pharmaceutical companies quickly and they are easy to contact. Of course, they are busy, but they are very responsive to COVID-19 questions and we’ve experienced that ourselves.
Due to the shortage, we think the laws and guidelines will need rethinking. A shortage like this shouldn’t happen and we shouldn’t be so dependent on other countries to help out in these circumstances. We will need to rethink the stock and manufacturing of products.
In terms of distribution and market share, let’s return to the oxygen distribution issue. In Belgium, there is a company that holds a large percentage of the share of oxygen in the market. That company can’t deliver alone. This begs the question, what do we do in a pandemic like this and which tools can we create to help us if there is a next time?
Many countries have seen a change in the reimbursement procedure – which has been stopped. For instance, in Belgium , as of 13th of March all procedures stopped and changes are expected in the future to the criteria on the reimbursement side.
We have also seen a lot of flexibility in EU regulatory guidelines, including on drug submissions and packaging and labelling, as there just isn’t enough time to follow the usual procedures. It will be interesting to see if this flexibility will carry over after the pandemic, even if only under certain conditions.
We could even see a surge in the creation of more digital tools for patients to be able to conduct trials at home more frequently. Of course, the industry is already very digital, but this could push businesses into an even more digitalised world. A large change is coming through trying new things that were previously not regulated – or even forbidden / not reimbursed. For example, the direct monitoring of patients. In Belgium you require physical contact with the patient for reimbursement purposes but, now that there is a necessity for less direct contact, that legislation has begun to change. And it will be interesting to see if these changes will be implemented in the future, or even if there are any benefits to these new procedures and tools.
Annabelle Bruyndonckx and Vladimir Murovec created a summary of the regulatory updates and changes in the Belgium market, which serves to help the pharmaceutical and medical device industry in keeping up-to-date with everything.
If you would like to read this summary, you will find it here:
VIEW THE SUMMARY
