Euro Roundup: Industry calls for UK government funding to fix ‘significant’ capacity issue at MHRA
The Association of the British Pharmaceutical Industry (ABPI) is pressuring the UK government to give the medicines regulatory agency enough resources to provide a “predictable and quality service.”Brexit and budget changes contributed to delays in the processing of applications by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in 2022 and 2023. The agency has since worked to clear its backlog and embarked on a strategic plan that prioritizes “predictable and reliable operational performance.” However, ABPI believes the agency is currently falling short of that goal.
According to the trade group, “capacity at the MHRA is currently a significant issue that places limitations on the regulator’s ability to offer a predictable and quality service to its customers.” ABPI said the UK government can address the problems by “sufficiently resourcing the MHRA.”
Data for January 2024 show MHRA assessed 97.2% of initial clinical trial applications, falling just short of its 98% target. The proportion of initial authorization and variation applications processed on time ranged from 6% to 100%, depending on the type of submission. More than 1,130 individual product licenses were overdue as of 5 February.
ABPI made the comments on MHRA capacity in a paper about its wishlist for next month’s UK budget statement, when the government will discuss the nation’s finances and its proposals for changes to tax. The request for funding of MHRA was part of a wider ABPI proposal for “delivering a globally competitive regulatory system that supports innovation.”
As ABPI explained, drug development “has become increasingly global” and multinational companies “must make informed and often challenging decisions about where and when to locate their activity.” A country’s regulatory framework is one factor that informs those decisions, leading the trade group to argue that it is “vital for regulators to provide a globally competitive approval system.”
Sufficiently resourcing MHRA is one of two ways ABPI believes the government can deliver a globally competitive regulatory system. The other way is to fully implement the recommendations of two reports that reviewed commercial clinical trials and how to regulate emerging technologies. The other items on ABPI’s budget wishlist relate to tax, public investment and delivery of the life sciences program.
Press Release, ABPI Paper
Generic drugmakers push for European reforms to secure supply of essential medicines
A trade group representing generic drugmakers is calling for the alignment of procurement policies that strengthen supply security across the European Union.
The trade group, Medicines for Europe, believes healthcare budget pressures have led EU countries to adopt procurement rules that aim exclusively to reduce the cost of buying medicines. That focus has led to the consolidation of supply, the trade group said, and increased the risk of disruption. Medicines for Europe sees the EU’s recent move to tackle shortages as an opportunity to address the problems.
“We strongly support the ambition of the European Commission to issue EU guidance on procurement, which we consider one of the key actions that would contribute to mitigating shortages, by reducing the counterproductive economic incentives that are largely responsible for them,” Arnaud Maheas, chair of the generic market access committee at Medicines for Europe, said in a statement.
The trade group set out its views in a position paper that features “concrete proposals on how to better design tenders.” Medicines for Europe is focused on five points: supplier diversity, demand predictability, the prevention of disproportionate penalties, prices that adjust to market changes and the use of most economically advantageous tender (MEAT) criteria.
Medicines for Europe expands on each point in the paper. The trade group wants to see MEAT criteria harmonized across the EU, “especially relating to global manufacturing processes,” to “prevent fragmentation, undue administrative burden and avoid limited positive impact of the introduced award criteria in medicines procurement.”
The generic drug industry is proposing a focus on criteria related to the environment and the security of supply. Medicines for Europe noted that procurers may lack the expertise to assess the sustainability of pharmaceutical manufacturing but believe a focus on “industry standards and established platforms for publicly available standardized information” can reward companies that invest in green technologies.
Through the supply security criteria, the trade group wants procurers to “reward manufacturers that have demonstrably good practices that offer additional supply robustness,” rather than assuming that all “marketing authorization holders have an undifferentiated supply chain.” Medicines for Europe is calling for criteria that assess the reliability, resilience and transparency of a company’s supply chain.
Press Release, Position Paper
EMA, HMA create catalogs of real-world data and studies to promote transparency
European officials have created two real-world research catalogs to help regulators, researchers and drug developers “identify the most suitable data sources to address specific research questions.”
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) created the catalogs. One catalog covers real-world data (RWD) sources and replaces an existing EMA-coordinated index of resources, the ENCePP Resources Database. The other catalog features RWD studies and replaces the European Union electronic register of post-authorization studies, the EU PAS Register.
According to EMA, the catalogs are improvements over their predecessors because they use an “agreed set of metadata to describe and connect data sources to studies.” The metadata is based on a list created by EMA and HMA in 2022. Other improvements include the implementation of the ability to “search on a wider set of metadata,” plus “enhanced view, export and data submission functionalities.”
EMA is encouraging European data holders, marketing authorization holders, networks, researchers and institutions to use the catalogs. The agency believes the resources can support the assessment of study protocols and results, promote transparency, encourage good practices, and build trust in RWD research.
Press Release
MHRA imposes changes to pseudoephedrine labels, reclassifies codeine after safety reviews
MHRA is imposing changes to the labels of medicines containing pseudoephedrine and reclassifying codeine linctus as a prescription-only product after completing reviews of the safety of the ingredients.
Pseudoephedrine has been used in the UK for decades to provide symptomatic relief of nasal and sinus congestion. Very rare reports of inflammation and reduced blood supply to the brain led MHRA to look at the latest evidence. The agency concluded the safety information needs updating to “provide clearer descriptions of these risks and potential risk factors for these conditions.”
MHRA is advising against the use of pseudoephedrine in people with very high blood pressure, as well as in people with acute or chronic kidney disease or kidney failure. Patients who develop symptoms of the brain adverse events, such as a severe headache that develops very quickly, should seek urgent medical attention.
The agency disclosed the actions alongside news of the completion of its review into codeine linctus, a cough suppressant. MHRA reclassified the ingredient as a prescription-only medicine because of the risk of abuse. The ingredient is misused as a recreational drug beverage known by names including purple drank. Yellow Card reports indicated instances of the medicine being abused.
Press Release, More
Other News:
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has scheduled a public hearing to discuss the benefits and risks of phthalates in certain medical devices. SCHEER Notice
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