Swedish medicine safety expert to head EMA’s pharmacovigilance committee [Advocacy Lab Content]

1 month ago 19

The EMA’s safety committee, which keeps a watchful eye on the safety of all medicines for human use in the EU, has elected its Swedish member, Ulla Wändel Liminga, as its new chair for a six-year term.

The July meeting of the EMA’s (European Medicines Agency) Pharmacoviligance and Risk Assessment Committee, PRAC, was the last plenary meeting chaired by Sabine Straus, who is stepping down after two three-year mandates.

Instead, Ulla Wändel Liminga, a pharmacist by training, and scientific director of pharmacovigilance at the Swedish Medical Products Agency, will take on the lead role on the important safety committee.

“It feels a bit overwhelming at the moment, but I have been working in pharmacovigilance for many years, so I will find it exciting to work in the committee from a chair’s perspective,” she told Euractiv.

A challenging term

Wändel Liminga will be the third chair of PRAC, which she has served as one of two Swedish delegates since its inception in 2012. Ideally, she could stay for six years as she has been given a three-year mandate with an option to serve for another three.

The next few years could be challenging for the PRAC in many ways.

Digitalisation and innovation using more real-world clinical data (in contrast to patient data from controlled medicine studies) open up new possibilities for how medicines are developed and monitored.

Also, the fact that the EU will adopt new pharmaceutical legislation in the coming years will bring about organisational and potentially regulatory changes.

The EU Commission’s proposal simplifies the EMA’s structure from six working committees for human medicines to two main committees.

These would be the Committee for Medicinal Products for Human Use, CHMP, which recommends marketing authorisations, and the PRAC, which monitors the safety of medicines for human use.

Streamlined safety procedures

“Our methods have matured over the last 10-15 years, and today, we have very well-developed risks and safety routines in place that help us to look at the safety profile of each medicine, new as old ones,” Wändel Liminga said, explaining why regulatory changes do not concern her.

Among the methods in place is “a thorough, and I would say, a very sensitive monitoring system, that quickly picks up warning signals from member states or via EMA of a new potential safety risk, and a robust procedure to further evaluate such signals,” she said.

As a national committee member, she has also acted as a rapporteur for hundreds of assessments of new safety data for medicines that have emerged after marketing.

Currently, Sweden has around 300 substances or medicinal products under safety assessment, of which Ulla Wändel Liminga herself is the responsible rapporteur for around half.

As an incoming chair, though, she will hand them over to a new Swedish full member of the PRAC.

“For every product, the risk-benefit balance is concluded upon, where the positive effect on a disease is weighed against possible and identified risks. Our role is to help monitor and evaluate safety and to guide on how to minimise the risks,” she said.

According to Ulla Wändel Liming, the spring of the pandemic year 2021 was the most intense period in PRAC’s history.

“It was incredibly intense as we were monitoring the safety of the new COVID-19 vaccines very closely, including the safety evaluations of some side effects that emerged when these vaccines were started to be used among a very large number of persons,” she explained.

Strong expertise

According to the EMA, Ulla Wändel Liminga has “strong expertise in pharmacology, toxicology, and pharmacovigilance.” She started working with pharmacovigilance about 25 years ago, but as early as 1993, she submitted a doctoral thesis in medical sciences at Uppsala University on animal models to detect side effects of neuroleptics.

While the CHMP recommends whether new medicines should be placed on the European market, the PRAC has a smaller role in the initial approval process, advising on the risk management plan that pharmaceutical companies should follow.

“We give CHMP advice on pharmacovigilance and risk minimisation activities for each new product in a plan to reach an optimal safety follow-up after market introduction,” she said.

Ulla Wändel Liminga will start her new job as chair of the PRAC on 2 September.

[By Monica Kleja, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]