We usually hear about the work of national and international authorities in medicine regulation only when something goes wrong. For example, when the side-effects of a new medicine are so serious that it is withdrawn from the market, or when there is a shortage of essential drugs to treat cancer or another serious condition.
However, with the imminent arrival of Covid-19 vaccines, the role of regulatory agencies has come into sharp focus. "We have to make sure that we are the oracle on scientific information about vaccines," says Emer Cooke, a Dublin native who has just been appointed as the new head of the European Medicines Agency, or EMA.
“I’m a bit worried that the debate on whether the Covid-19 vaccines work or not is happening in the media before the data is in and they can be evaluated. Drug manufacturers always issue press releases before trials end but there has never been such media attention on it before.”
On November 11th – two days after Pfizer released information about the efficacy of their Covid-19 vaccine – the European Commission strengthened the agency's role to co-ordinate clinical trials and studies to monitor the effectiveness and safety of vaccines, as well as its mandate to give scientific advice on medicines and manage the risk of shortages of critical medicines.
Last Wednesday, the UK became the first country to approve the Pfizer-BioNTech Covid-19 vaccine for use and said that it will be rolled out from this week. In a statement last week, the European Medicines Agency said: “EMA considers that the conditional marketing authorisation is the most appropriate regulatory mechanism for use in the current pandemic emergency.” It also said that procedure was based on more evidence and more checks than the emergency procedure chosen by the UK.
The US Food and Drug Administration is set to meet this Thursday to discuss whether to recommend emergency use authorisation of the vaccine, and the European Medicines Agency said it could give emergency approval by December 29th.
When a new vaccine or medicine comes on the market, the agency gives it a conditional marketing authorisation for one year during which time the drug company has to provide more information on its use so that the agency can review it at the end of the first year. “We will be monitoring these new Covid-19 vaccines closely for safety, quality and efficacy. And rather than asking for data every six months, which we usually do, we will ask for data on a monthly basis,” says Cooke.
New role
With 30 years' experience in international regulatory affairs for the European Commission in Brussels, the World Health Organisation in Geneva as well as previous roles at the agency in its former headquarters in London, Cooke sounds excited about her new role when we speak just four days into her job at the agency headquarters in Amsterdam.
As well as giving approval – or not – for new medicines, the agency also has responsibility "to monitor and mitigate against" the risks of shortages of critical medicines and medical devises. "At the moment, there has been a big surge in demand from intensive-care units for antibiotics, some neuromuscular blockers and sedatives but the agency hasn't been notified or critical shortages of any of these medicines. In some cases, the active pharmaceutical ingredients of medicines come from India or China and these countries are retaining the products for their own populations," explains Cooke.
Anti-microbial resistance is another big concern for regulators, given that by 2050, it has been predicted that superbugs which don't respond to antibiotic medicines could be a bigger threat to human life than cancer. During the annual focus on antimicrobial resistance in mid-November, the director general of the World Health Organisation, Tedros Adhanom, said that while anti-microbial resistance might not seem as urgent as a pandemic, it is just as dangerous.
Speaking to The Irish Times in 2018 in her former role as head of regulation of medical products at the WHO, Cooke said: “There is still not enough awareness of the risk of antimicrobial resistance. The challenge is that we could end up in a situation that the products we have to treat life-threatening conditions such as meningitis, MRSA and other hospital infections will no longer work.”
Now, she adds: “It is likely that more people will die from antibiotic resistance than from Covid-19.”
The European Medicines Agency – which will host an international open public meeting on the European regulatory process (see ema.europa.eu) on December 11th – promotes responsible use of existing antibiotics and supports the development of new antibiotics, antiviral and anti-fungal medicines (collectively known as antimicrobials).
“You can’t control antimicrobial resistance unless antibiotic use is tackled in humans and animals. Together with the Organisation for Economic Co-operation and Development, we monitor the consumption of antimicrobials in animals,” says Cooke, who did her master’s degree in drug resistance at the school of pharmacy at TCD after her undergraduate degree in pharmacy at that college. Interestingly, the sale of veterinary antibiotics in European countries reduced by a third from 2011 to 2018.
Another concern
European shortage of medicines manufactured or released in the UK is another concern within the ongoing struggle to finalise EU/UK trading agreements following Brexit. Any UK-based drug company marketing a medicine in the EU must formally transfer its licence from the UK company to one that is based in the EU/EEA by the end of 2020. And many have already done so.
“We will also have to find new experts to mitigate the absence of rapporteurs based in Britain who [previously] evaluated products through a centralised system,” explains Cooke.
In the last number of years, patients have gained a voice in the regulatory process, particularly in relation to new treatments for small numbers of patients. “We tend to be very cautious about authorising medicines with [strong] side effects, aware that patients might not accept the risks involved but we hear from patient organisations about the huge difference some of these medicines can make,” says Cooke, who also stresses how the agency needs to work with member states, the European Commission and European Parliament to make sure patients have access to the medicines they need.
Patients are also involved in the revision of patient leaflets for drugs. “Companies must submit proposals for patient leaflets which we modify regarding their indication, and what side effects are justifiable. The companies also submit translations of patient leaflets into other languages for our approval.”
The dearth of technologists at the agency is something Cooke hopes to change. “We’ve got scientists, doctors and pharmacists but as the divide between medicine and technology becomes blurred in diagnosis of conditions and delivery of medicines, we need technologists,” she says. “For example, we have to ask if we can rely on artificial intelligence to detect cervical cancer.”
And finally, just before our conversation ends, she adds: “I also have a dream that we’d be able to connect patient electronic health records with information on adverse affects. We will need to think about data protection regulation so that we can protect personal data yet aggregate this data for public health [research].
“Ultimately, we need the public to know that we’re here to protect them from the risks of medicines and vaccines.”
