EU Regulatory Roundup: Denmark Teams With WHO to Help Build Regulatory Capacity in Poorer Countries

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
 
UK Government Holds off Backlash Against ‘Extraordinary Power Grab’ on Drug Shortages
 
The United Kingdom government has resisted an attempt to revoke changes to the handling of drug shortages. An opposition politician called the serious shortage protocol reforms an “extraordinary power grab” but was unable to rally enough support in parliament to get the changes revoked.
 
Through the reforms, the government aims to empower pharmacists to substitute drugs in certain circumstances. The law creates a mechanism that enables the Department of Health and Social Care (DHSC) to issue shortage protocols. That done, physicians will develop and approve a substitution protocol for pharmacists to follow when they receive a request for a particular out-of-stock drug. The protocol will free pharmacists from the need to consult with prescribers.
 
The government advanced the reforms following a short, informal consultation but without holding a full parliamentary debate. Participants in the consultation raised concerns, such as the potential to overburden pharmacists and DHSC, that were picked up this week by opposition politicians angry at the government for using its powers to bypass the need for a full debate.
 
“The government should have brought these proposals to the House for full debate and scrutiny, because the serious shortage protocol is perhaps one of the most far-reaching and contentious of the government’s changes to medicines regulation in recent times,” Jon Ashworth, a member of the opposition Labour Party, said in a statement.
 
“These reforms represent a quite extraordinary power grab whereby ministers can grant themselves the authority to instruct local pharmacists to ration drugs, overrule the GP’s prescription and dispense therapeutic generic equivalents or reduced dosages in the event of a medicines shortage.”
 
Ashworth’s view is supported by bodies of medical professionals, one of which said the government’s handling of the reforms was “inexplicable and unacceptable.” Other politicians, from both the main parties, joined Ashworth in criticizing the reforms in a debate that could have resulted in a vote to revoke the serious shortage protocol. However, the vote largely split along party lines, enabling the ruling Conservative Party to resist the attempt to revoke the reform by a margin of 292 votes to 240.
 
In defending the shortage protocol, government representative Jackie Doyle-Price argued that there is a lot of misinformation about the regulations. Doyle-Price thinks this has led to overblown worries.
 
“The protocol will be very tightly drafted, which will really limit the ability of the pharmacist, who would only be able to prescribe outside the terms of the prescription within the narrow confines of the protocol,” Doyle-Price said.
 
Echoing earlier comments by the Medicines and Healthcare products Regulatory Agency (MHRA), Doyle-Price said the reforms are unrelated to Brexit. However, the government’s decision to quickly enact the reforms in the run up to Brexit and the supply disruptions it could cause has linked the two topics in many politicians’ minds.
 
Debate Transcript
 
Denmark Teams With WHO to Help Build Regulatory Capacity in Poorer Countries
 
The Danish Medicines Agency (DKMA) has joined with the World Health Organization (WHO) to build up drug and medical device regulatory authorities in low and middle-income countries. DKMA and WHO will work to equip regulators to ensure the supply of safe essential drugs around the world.
 
WHO research suggests up to 70% of drug regulatory authorities lack the capabilities to carry out key tasks effectively. There are gaps in the capabilities of the other 30%, too.
 
To improve the situation, DKMA will work with WHO to spread the knowhow it has built up in the European market to its peers in other parts of the world. DKMA singled out drug licensing, side effect monitoring, supply chain protections and communication between regulators, providers and patients as areas in which it may be able to help.
 
The Danish regulator cited its improved performance on the Benchmarking of European Medicines Agencies (BEMA) as a reason why WHO was keen to involve it in the work. DKMA scored 4.5 out of 5 on the most recent BEMA assessment by the Heads of Medicines Agency, up from 3.9 at the time of the previous review in 2014.
 
DKMA’s improved performance on the benchmarking and interest in participating in global initiatives such as the WHO capacity building program are products of the revised strategy adopted by the agency late in 2015. Back then, Denmark re-established DKMA and started hiring leaders with international experience with a view to turning the agency into a leading European regulator.
 
The strategy has seen DKMA work to increase its share of rapporteurships on European Medicines Agency (EMA) projects, particularly as MHRA’s involvement has waned, and hold a series of meetings with Chinese authorities. The bilateral interactions with China have led to joint activities including a pilot project on clinical trials and medicines evaluation.   
 
DKMA Notice
 
Dutch Drug Shortage Reports Jump 159% as Awareness of Hotline Rises
 
The Dutch Medicines Evaluation Board (MEB) has reported a 159% increase in the number of drug shortage reports. MEB thinks the increase was largely driven by more comprehensive reporting of drug shortages, rather than a dramatic rise in supply problems.
 
In 2017, MEB received 536 drug shortage reports. Last year, the figure rose to 1,390. MEB attributed the rise to wider knowledge and use of its hotline for reporting shortages, although it acknowledged that the actual number of supply problems rose over the period, too. The agency wants companies to contact the hotline early so there is time to mitigate the effects of supply constraints.
 
That approach appears to be working. MEB said a solution was found for almost all the shortages reported last year. Solutions include the use of other medicines, importation of drugs sold overseas and the use of different doses of the drug that is unavailable.
 
Last year, half of the shortages reported to MEB stemmed from production delays. Another 16% were due to demand exceeding supply, in many cases as a result of the shortage of a competitor’s product.
 
MEB Notice (Dutch)
 
France Gives Mesh Manufacturer 6 Months to Comply With Regulations
 
France’s regulator has faulted practices at Microval as part of its efforts to ensure compliance with mesh implant manufacturing requirements. Microval has six months to comply with the regulations.
 
The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) embarked on the inspection program as part of its efforts to ensure the safety of mesh devices, which have been linked to complications that have triggered regulatory reviews around the world. ANSM has now finished seven inspections as part of an ongoing regulatory action.
 
ANSM found nonconformities during its inspection of Microval, the French manufacturer of the Prolafix brand of implants. The agency plans to give Microval six months to resolve the issues and will then carry out a follow-up inspection.
 
Officials at ANSM shared the news as part of a periodic progress report on its mesh activities. ANSM also used the update to disclose that it is providing additional funding to a study of the short- and long-term complications of pelvic surgery. The researchers will use the money to recruit more patients at more hospitals.
 
ANSM Notice (French)
 
Other News:
 
EMA has published an ICH guideline on bioanalytical method validation for consultation. The draft is open for comment until the start of September. Draft Guideline, Focus