Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Lords Pressure UK Government to Wedge Open Door to Ongoing Involvement in EMA
The House of Lords is pushing to ensure the United Kingdom government does nothing to jeopardize the country’s chances of staying in the European Medicines Agency (EMA). Lords made their point in an amendment stating Brexit legislation must not prevent the UK’s ongoing involvement in EMA.
Members of the Lords are discussing and amending legislation covering the UK’s withdrawal from the European Union this week. The house has proposed more than 100 amendments to the document put forward by the government, including one that would place limitations on other sections of the act. Specifically, the amendment seeks to stop the erection of barriers to participation in EU agencies.
The amendment states: “Nothing in this Act shall prevent the United Kingdom from—(a) replicating in domestic law any EU law made on or after exit day, or (b) continuing to participate in, or have a formal relationship with, the agencies of the European Union after exit day.”
Members of the Lords passed the amendment by 298 votes to 227. By voting for the amendment, the Lords has ensured members of the other, elected chamber of the UK Parliament will have a vote on the matter when it next debates the legislation. However, given the government lost one vote and made few concessions when the House of Commons first debated the bill, it is questionable whether the amendment will garner enough support to pass.
While the government is likely to oppose the amendment, it shares the proposal’s central goal of an ongoing close relationship with EMA. Prime Minister Theresa May has explicitly stated the UK wants to remain part of EMA and certain other EU agencies. The problem is it is doubtful whether this wish is compatible with red lines the UK has set in other areas, such as its refusal to countenance staying in the single market. The EU has said little to encourage the UK that its goal is realistic.
A separate amendment voted for by the Lords could bring the UK closer to the EU’s position. The amendment called for the UK to stay in the European Economic Area (EEA). Other members of the EEA, such as Norway, are in EMA. The Commons will vote on the EEA amendment when it debates the bill.
Ireland’s HPRA Proposes Cuts to Medical Device Fees Following Industry Complaints
The Irish regulatory agency is proposing to cut the fees it charges all but the largest medical device manufacturers. Ireland ran consultations before introducing device regulatory fees for the first time last year, but nonetheless received pushback from businesses that felt the charges were excessive.
Faced with the criticism and equipped with a better understanding of the national medical device sector, Ireland’s Healthcare Products Regulatory Authority (HPRA) is set to lower its fees in 2018. The revised fee structure features reductions in almost every area. The major exception is the fee HPRA charges to large medical device manufacturers, which will remain unchanged.
HPRA is proposing to continue charging €30,000 ($35,600) to manufacturers with more than 150 employees. The fees for most smaller manufacturers will fall by between 20% and 75%. Companies with five to 15 employees will receive the biggest cut in percentage terms.
The regulator proposed the structure after coming to understand that a small number of companies account for a large portion of the Irish device sector’s €12 billion annual turnover. A long tail of small businesses with similarly small sales figures trail these multinational companies. HPRA has little, if any interaction, with the small firms and as such its 2017 fees failed to fully cater to their needs.
In addressing the shortcomings of its 2017 fees, HPRA has potentially created a problem for itself. The income generated from the 2018 fees will fall short of what HPRA needs to cover its costs as it works to implement the incoming EU device rules and adopt a medical device oversight IT system. HPRA expects Brexit to add to its workload, too. The result is HPRA will need government funding.
The structure put forward by HPRA reflects its improved understanding of the composition and needs of the sector, but the agency is conscious its knowledge remains incomplete. As such, HPRA thinks it may need to make further adjustments.
HPRA is accepting comments on the proposed fees until 25 May.
EMA Offers Advice on Managing Unexpected Deviations from GMPs
EMA has answered questions about managing unexpected deviations from good manufacturing practices (GMPs). The expanded question and answer document defines such deviations and delves into their implications for batch release and certification by a qualified person.
In EMA’s view, a deviation from GMPs is unexpected if it is occuring for the first time and meets certain other criteria. Repeat deviations that occur while a manufacturer is performing corrective and preventative actions are not classed as unexpected. Similarly, deviations that are planned or caused by miscommunication between marketing authorization holders and manufacturers are not treated as unexpected. The definition expands on a GMP annex that came into force in 2016.
Other sections of the updated Q&A further expand on the annex. One new question covers the registered specifications manufacturers must meet to satisfy the legislation on handling unexpected deviations. These specifications cover the process and the bulk and finished product. In some cases, manufacturers can deviate from in-process specifications without affecting product quality.
The other new question is centered on whether qualified person certification of multiple batches affected by the same deviation is permissible. EMA’s response confirms this is acceptable.
, Annex 16
CVMP Finalizes Guidelines on Groundwater Health Risks, Topical Drug Safety
The Committee for Medicinal Products for Veterinary Use (CVMP) has adopted final guidelines on the risks posed by drugs in groundwater and the safety of users of topical products.
CVMP’s groundwater guideline covers how to assess and quantify the risk veterinary medicines pose to ecosystems and human health once they enter the water cycle. One section of the guideline provides a methodology for assessing the risk a drug poses to human health if it gets into drinking water. Others provide similar tools to analyze the likely impact of a drug on groundwater ecosystems.
The EMA committee signed off on the groundwater guideline at the same time as adopting the final text on the safety of human users of topical veterinary medicines. CVMP has seen a sharp rise in applications for topical veterinary medicines in recent years, raising concerns about the potential for harm to humans through hand-to-mouth contact and other routes.
To manage these risks, EMA has created a guideline that walks veterinary drug developers through the assessment of the safety implications of medicines that remain on the surface of an animal’s body after administration. The guideline is aimed at developers of treatments for companion animals but it may also be applicable to food-producing animals.
Both guidelines will come into force at the start of November.
, Safety Guideline
The Medicines and Healthcare products Regulatory Agency
(MHRA) is seeking applications for three non-executive director positions on its board. MHRA wants to appoint a patient representative to fill one of the vacancies. MHRA Notice