The MEB in 2022

A year of change

For many months, 28 January 2022 had been marked in bold in the diaries of staff in the Veterinary Medicinal Products Unit. The day came at last: the day when the new Veterinary Medicinal Products Regulation came into force. “In the lead-up to the Regulation taking effect, we were incredibly busy,” says Peter. “Once we’d reached the milestone, we thought we could return to calmer waters. Nothing could be further from the truth. Like previous years, 2022 was completely dominated by the Regulation.”

The Regulation required a number of adjustments, even after the law change took effect. “So much happened, there’s really too much to mention,” says Peter. “First, we spent a great deal of time drafting national agreements on a wide range of subjects. From rules on the Internet trade in veterinary medicinal products to the inputting of wholesalers, manufacturers, importers and distributors into the EudraGMDP database. We also had to adjust many of our procedures. Everyone had a part to play and we held many discussions with the Ministry of Agriculture, Nature and Food Quality. We did that in ‘theme teams’”.

We haven’t been sitting idle in the European arena, either. “In working groups of the Co-ordination Group for Mutual Recognition and Decentralised procedures – Veterinary (CMDv) and the Committee for Medicinal Products for Veterinary Use (CVMP), staff have worked hard to mould all the new legislation into new guidelines.” 2022 also saw the introduction of the Union Product Database (UPD). As Peter explains, the UPD contains all the veterinary medicinal products that have a marketing authorisation in Europe. “There are now more than 40,000 veterinary medicinal products in the UPD. The submission and processing of administrative changes will now be done entirely via the UPD. This has taken some time to get used to, for both the VMPU and marketing authorisation holders.”

“We organised information sessions to help marketing authorisation holders and other stakeholders get used to all the changes. Although we had to hold them online, because of COVID. The average turnout was 150 participants, which showed there was a lot of interest. And all of the sessions were highly appreciated.”

As Peter explains, the Regulation kept the VMPU just as busy in 2022 as it had in 2021. “I’m immensely proud of the fact that, as a team, we managed to keep so many balls in the air, and also ensure all our other procedures continued normally.”

See also:

• Europe - the MEB is among the leaders
• Europe - Active in Europe
• Science - A year of collaboration
• Communication - A year of great trust in medicines

The MEB is among the leaders

“In terms of procedures and ‘production’, and the amount of work we do within the European network, we’re among the leaders,” says Aimad. “This proved true again in 2022. The MEB staff who chair various committees at the European level are a great example of our shared responsibility at that level. It shows how relevant we are in the network. So it’s good to take a critical look at what knowledge we need and must secure or expand.”

PRAC Chair Sabine Straus notes that work resulting from the Covid pandemic is gradually taking up less of the committee’s time. “In 2022, it was great to be able to return to a more normal pace of work. Many projects and strategic plans had been shelved because of Covid. In 2022, we were able to start them up again.”

At the same time, Sabine knows Covid has not gone away. “There’s still a lot of it around, and that will remain true for a while. We’re still getting a lot of questions, particularly about the Covid vaccines. There’s been research into what mechanisms cause certain adverse reactions, and whether certain conditions are actually adverse reactions.

Aimad points out that the work of the MEB and the Dutch representatives in Europe is once again becoming more visible. “Medicine authorities are under scrutiny, which has both positive and negative aspects. We can respond more quickly when something happens, but it also generates more debate and more work. Next year, we want to look at whether there’s a different way we could approach that work.”

Looking back, Aimad says the year has been busy. “The aftermath of the pandemic and Brexit created a lot of work in 2022 for the European network of medicine authorities. The departure of a member state that had always taken on a lot of work meant that tasks had to be redistributed.”

“In addition to ongoing cases and the analysis and assessment of reports about the Covid vaccines, there were various other major procedures and reassessments, including referrals,” says Sabine. “These always involve special, more intensive processes.” She is proud of the way the PRAC has handled everything. “In spite of the amount of work, we’ve continually been guided by the available data and scientific assessments in our decisions, which I think is great.”

Collaboration

Medicine shortages have regularly made the news in the Netherlands. “But the problem is not confined to the Netherlands,” says Aimad. “It’s occurring throughout Europe. The options available to the European Medicines Agency to address this issue are being expanded, and with good reason.”

Pharmacovigilance is another area in which collaboration opportunities are being sought outside of the usual network. Sabine explains an initiative to improve the effectiveness of the PRAC’s recommendations. “We were the first body within the EMA to study the impact of our work. What do doctors do with the recommendations we issue based on our data? We have now set ourselves the goal of having more discussions with other parties. In 2022, PRISMA (PRAC Risk Minimisation Alliance) was launched, a group in which we will work with patients, pharmacists and care providers to look at how we can further limit the risks of medicines.”

Aimad and Sabine agree that more collaboration is needed at the European level. “In the longer term, the borders should be opened further,” says Aimad. “For international matters, we need to collaborate more within Europe. That’s one thing we learned during Covid. We’re going to be doing that with the European Health Union, for example. After all, health problems do not respect national borders.”

Looking ahead

In 2022, the Veterinary Medicinal Products Unit did a lot of work related to the introduction of the new Veterinary Medicinal Products Regulation. “That implementation work is starting to pay off,” says Aimad. “For human medicines, too, there’s going to be new international pharmaceutical legislation in the next few years. Laws that stimulate innovation and make the system more future proof. The current legislation is several decades old. Is that system still working well? What have we learned, and what do we expect in the future? There was a change of gears in 2022, it was a real transition year.”

See also:

• Europe - Active in Europe
• Science - A year of collaboration
• Communication - A year of great trust in medicines
• Veterinary Medicinal Products Unit – A year of change

Active in Europe

The European Medicines Agency (EMA) has a variety of working groups and other related groups. These groups give advice to the EMA’s scientific committees on issues related to their subject area. “With the creation of the ETF in 2022,” says Ingrid, “There is now a working group dedicated to activities undertaken in preparation for and during an emergency situation relating to public health, such as a pandemic. The ETF is actually a continuation of the COVID-19 Pandemic Task Force. That was set up in March 2020 when the World Health Organisation (WHO) officially declared COVID-19 to be a pandemic.”

“In 2022, we moved into calmer waters with regard to COVID-19. To ensure that, in addition to the current COVID-19 pandemic, we are well prepared for other potential pandemics, the scope of the ETF is broader than the tasks assigned to the COVID-19 Pandemic Task Force. This is a positive development, because it will help us be as prepared as we can be for a potential new pandemic. For example, we have been doing work around the Mpox (Monkey pox) outbreak, and providing scientific advice to manufacturers in relation to developing vaccines for various other viral infections.” The fact that the COVID-19 pandemic has faded from everyday life is something Ingrid also noticed in her work for the Scientific Advice Working Party (SAWP). “A high point of 2022 was that half of the SAWP meetings were once again held in person. I think that holding the meetings in Amsterdam adds significant value. Each meeting can last for up to three-and-a-half days, which is a long time to spend in a virtual meeting. You notice that you get more energised by meeting in person. What’s more, after the meeting you can often spend time together discussing and clarifying various subjects.”

The SAWP focuses on scientific advice for medicine developers, including how they can best set up their studies to identify the benefits and risks of medicines as accurately as possible. The SAWP does this work on behalf of the Committee for Medicinal Products for Human Use (CHMP). “The number of requests for advice received by the SAWP has continued to grow in recent years,” says Ingrid. “But there’s been no expansion in personnel. In addition, a number of members were busy with COVID-19 in 2020 and 2021. These factors are part of the reason why we had a backlog at the start of 2022. Thanks to a tremendous effort by the members of the SAWP, we made a substantial dent in the backlog of advice requests in 2022.”

Ingrid is proud of Dutch representation in Europe. “The SAWP is an example of that strong representation. The Netherlands is one of the leading countries in terms of the number of advice requests for which we take responsibility. The Netherlands is also well represented in other working parties.”

See also:

• Europe - the MEB is among the leaders
• Communication - A year of great trust in medicines
• Veterinary Medicinal Products Unit – A year of change
• Science - A year of collaboration

A year of collaboration

In the area of science, collaboration was a major feature of 2022. Which is logical, because regulatory science looks beyond borders. “That’s why we collaborate so much,” says Marjon. “With academic groups and other knowledge institutions, but also with the EMA and other national medicine authorities. We’re part of various public-private partnerships, such as the Regulatory Science Network Netherlands (RSNN), and we collaborate with FAST (Future Affordable & Sustainable Therapies). We also play a role in the National Growth Fund project ONCODE-PACT, and contribute to the Innovative Medicines Initiative project EPND and the Horizon Europe-funded project PRIME-CKD. These projects involve research into biomarkers for neurodegenerative diseases and chronic kidney diseases respectively.”

These collaborations produced tangible results in 2022. “Five researchers completed their PhDs in 2022, while a number of new Bachelor’s, Master’s and PhD students started. They’re working on a wide range of projects aligned with the eight themes of our science policy. In 2022, that led to a total of 40 scientific publications in which MEB staff were involved.”

A major milestone at the European level in 2022 was the completion of the STARS project. “‘Strengthening Training of Academia in Regulatory Science’ was a three-year European project involving most European medicines authorities and the EMA. With STARS, we focused on improving the interaction and exchange of knowledge between academic researchers and medicines authorities. The ultimate goal was to promote the advancement of academic medicine development.”

STARS led to 21 recommendations designed to help strengthen interactions between regulators and academics. “These include more knowledge development and training for academic researchers,” says Marjon. “There’s also a recommendation to improve how medicines authorities communicate, and another on how we can help improve researchers’ processes.”

The topic for the MEB’s Science Day in February 2022, ‘Strengthening academic drug development’, tied in perfectly with this subject. “It was held online due to the Covid measures, but we were able to bring together parties from health care, the academic world and the industry.”

See also:

• Communication - A year of great trust in medicines
• Veterinary Medicinal Products Unit – A year of change
• Europe - the MEB is among the leaders
• Europe - Active in Europe

A year of great trust in medicines

In the second half of 2022, the pandemic became less of a focus in our communication work. But it didn’t disappear completely. Dony says COVID-19 is still taking up a lot of time. “In particular, the approval of the first Covid pill and the bivalent Covid vaccines adapted to the Omicron subvariants attracted a great deal of media attention in September. Since the Covid pandemic began, the media have not been shy about contacting the MEB. We’ve often been in the spotlight during the pandemic due to our role in assessing the vaccines. We’ve had intensive contact with many journalists, answering questions and making media appearances. This strengthened our relationships with many journalists. That’s valuable, because it helps us reach the general public. That enables us to share reliable information and give correct explanations, for example on the efficacy of and adverse reactions to vaccines and medicines. Because people’s need for information is high, which is only logical.”

The need to share reliable information continued in 2022 due to the rise in disinformation. “It’s a growing problem. Combating disinformation about medicines and vaccines is a big challenge for us. We start by sharing information ourselves, then where necessary we also combat disinformation with reliable information. We keep an eye on disinformation through daily media monitoring. We want to pay even more attention to it next year, because unfortunately disinformation is timeless.” 

The number of medicine shortages increased in 2022. “The critical shortage of an eye medicine had a particularly big impact,” says Dony. “For the small group of people who use it, the shortage could have lasting consequences. Medicine shortages are a challenging subject. The trickiest part is that the role of the MEB is limited, but it could have an impact on trust in medicines.”

In spite of the medicine shortages and increase in disinformation, trust in medicines and vaccines is high. This was shown in a study conducted in 2022 by the research agency Nivel on behalf of the MEB. “We didn’t know what to expect,” says Dony. “But we were very happy to find that trust in medicines is still high, and that the Covid vaccines also received satisfactory scores. This will have an influence on the appropriate use of medicines.”

With a score of 8.2, general trust in medicines has risen since 2018. Vaccines received a favourable score of 7.8. The score for Covid vaccines was lower, at 6.8. “We hope that good communication and transparency have contributed to that level of trust,” says Dony. “Trust in medicines and vaccines and the appropriate use of medicines are why we do what we do.”

Ultimately, everything we do is for patients. That’s why they had a prominent role on MEB Day. “Our annual MEB Day is the calling card of our organisation. It was great being able to see our stakeholders in person again, after two years. We’re proud of how this year’s MEB Day unfolded.” 

See also:

• Science - A year of collaboration
• Europe - the MEB is among the leaders
• Europe - Active in Europe
• Veterinary Medicinal Products Unit – A year of change