Posted 09 February 2017
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
ENVI Calls for EMA to Maintain Budgetary Reserve to Mitigate Brexit Volatility
A public health committee has called for officials to clear the European Medicines Agency (EMA) to maintain a budgetary reserve for use in the event of Brexit-related volatility. The committee thinks such a reserve is needed if EMA is to cope with the unforeseen costs and unfavorable exchange rate fluctuations that could afflict it in 2017 and beyond as a result of Brexit.
Politicians who sit on the European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) are concerned that unless precautions are taken, EMA may struggle to carry out its responsibilities effectively. The concern stems from a belief that the UK’s decision to leave the EU puts EMA at “risk of budgetary volatility.” As an EU institution currently working in the UK, the Euro-British Pound exchange rate is one potential source of volatility. ENVI is conscious other issues could also arise as the UK makes its way to the EU exit.
ENVI made the point to the Committee on Budgetary Control in its opinion on the EMA budget for the 2015 fiscal year. The public health committee voted by 50 to 19 to close and approve EMA’s accounts for the year. In doing so, it also made a series of points about EMA’s financial performance and upcoming areas of concern, including the potential for Brexit-related budgetary volatility.
The note on Brexit is part of broader concerns raised by ENVI about the ability of EMA to manage its growing workload. While EMA has offset increases to its workload by recouping more in fees from applicants, ENVI is worried about staffing levels in some areas.
Specifically, ENVI “[noted] with concern that the imposed staff cuts in recent years included staff working on tasks financed by applicants’ fees without regard to the workload involved.” To address the concern, ENVI “strongly supports ... the introduction of flexibility in adjusting the number of establishment plan posts for staff working on tasks financed by applicants’ fees, in line with increasing demand.”
ENVI raised these concerns as part of an opinion text that is broadly complimentary of how EMA managed its budget and operations in 2015. As ENVI notes, the period under review included time when EMA needed to recruit an executive director following the Civil Service Tribunal annulment of the 2011 appointment of Guido Rasi. “Despite that difficult situation, the agency delivered its work program,” ENVI wrote.
UK Politicians Fail to Enshrine Importance of EMA Participation in EU Exit Bill
UK politicians have failed to get a clause about EMA participation added to a bill that will clear the prime minister to trigger the start of the EU exit process. The proposed clause was designed to force the government to negotiate to retain the UK’s participation in EMA, something that is currently far from certain.
In the two weeks after the government introduced a short bill to empower the Prime Minister to start the process of exiting the EU, politicians drafted a slew of amendments designed to tie those in charge of Brexit to certain negotiating positions and reporting requirements. Among the proposed amendments was NC82, a clause that would increase the likelihood of UK retaining something like its current links to EMA post-Brexit.
However, the government has successfully faced down objections and secured a vote in favor of its original bill.
The EMA clause read: “In negotiating and concluding an agreement in accordance with Article 50(2) of the Treaty on European Union, Ministers of the Crown must have regard to the desirability of continuing to participate in the EMA on the same basis as any other member state of the European Union.” An accompanying note stated the aim was to ensure the UK continues to participate in EMA.
All 21 politicians who put the clause forward are either members of the opposition Labour Party or affiliated groups, notably the Social Democratic and Labour Party. Given neither the leader of the Labour Party nor its Brexit chief were behind the clause — and the party leadership was opposed to voting against the Brexit bill even if the government rejected their amendments — the chances of the request being added to the final text were always slim.
Despite the likelihood of the government pushing through its brief, clause-free bill, politicians filed a steady stream of amendments. Other clauses of relevance to drug and medical device regulation and development included two that sought to ensure the UK continues to participate in the European Research Area — or at least creates a draft framework for ongoing collaboration — and multiple amendments intended to protect the right of EU nationals to remain in the country after Brexit.
The bill has now passed to the House of Lords for further debate.
Bill Amendments, Final Text
Swissmedic Plans Random Checks on Compliance with Pyrrolizidine Alkaloid Limit
The Swiss Agency for Therapeutic Products (Swissmedic) is to start performing random checks on compliance with the limit on pyrrolizidine alkaloids. Swissmedic will embark on the program in the middle of this year to ensure manufacturers of herbal and complementary medicines are meeting the requirements.
EMA established a risk management and quality control plan for pyrrolizidine alkaloids last year to mitigate the danger of the chemicals. Researchers have known for decades that the chemicals, which occur naturally in multiple plants, can harm the liver. More recently, researchers have found pyrrolizidine alkaloids in products made from plants that do not contain the chemicals. Weeds that are harvested along with the target plant are thought to be the source of the contamination.
Officials have identified products derived from 10 medicinal plants that can contain substantial quantities of pyrrolizidine alkaloids, regardless of whether the chemicals are found in the medicinal plant itself. Manufacturers of plant-based active substances and finished products in the EU must therefore mitigate the problem to ensure they stay below maximum daily limits.
Swissmedic has followed EMA’s lead. The regulator has adopted EMA’s recommended limit and is encouraging the companies it regulates to perform risk evaluations and, if necessary, collect data on the content of pyrrolizidine alkaloids.
Products that fail to meet the maximum limit can no longer be sold in Switzerland. From mid-2017, Swissmedic plans to start enforcing this rule by randomly checking whether manufacturers have performed risk evaluations and meet the limit.
EMA Adds Clinical Data for two More Drugs to Website
EMA has added clinical data on Aripiprazole Mylan and Palonosetron Hospira to its website. A filing for approval of Aripiprazole Mylan was withdrawn in 2015, making it the first drug with a pulled submission to be added to EMA’s nascent data-sharing scheme.
The agency introduced the website late last year to further its commitment to sharing more clinical trial data on the drugs it regulates. Having started with data from two products in October, the site now features results for eight drugs.
Aripiprazole Mylan stands out because the application for its approval was withdrawn after EMA’s Committee for Medicinal Products for Human Use had evaluated the initial documentation and sent a list of questions to Mylan.
The company subsequently withdrew the application, citing the identification of major good clinical practice issues as an explanation for its action.