Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA Mulls Relaxation of Conflict of Interest Rules to Help Brexit-Affected Staff Find New Jobs
The European Medicines Agency (EMA) is considering relaxing its conflict of interest rules to help staff who leave as a result of Brexit. EMA’s changes could loosen the application of stipulations that regulate and potentially limit where former employees can work in the two years after leaving the agency.
As it stands, after EMA staff leave, they must declare paid and unpaid work they plan to do for two years. If the work is related to tasks the employee performed during their last three years at EMA and clashes with the agency’s interests, the executive director can intervene. The scope of possible interventions ranges from banning the person from taking the role to imposing conditions on their employment. Conditions include the prohibition of contact with EMA staff and involvement with certain dossiers.
EMA sees these restrictions as an important check on potential conflicts of interest but is open to the possibility they could create problems for staff who choose not to relocate to Amsterdam. As such, the agency plans to discuss the application of the regulations to these people “to facilitate the staff member to find new employment.”
History suggests most people who leave EMA because of Brexit will be unaffected by the two-year rule even if it is applied in its current form. In 2016 and 2017, EMA received 41 applications from former staff who wanted to take up employment elsewhere. EMA approved 31 of the applicants to take up their new roles without applying restrictions. The remaining 10 applicants were cleared to start the jobs provided they complied with certain conditions. No applications were rejected by EMA.
However, the situation facing Brexit-related departees could be complicated by a sudden increase in the number of ex-EMA staff seeking employment in London. An EMA survey performed last year found Amsterdam was the most popular city among EMA staff. Even so, around one-fifth of EMA employees said they were unlikely to relocate to the city, suggesting 170 or so staff may be looking for work at the same time when the agency leaves London next year.
EMA floated the idea of making it easier for the former employees to find work in its independence report covering 2016 and 2017.
Dosing Errors Prompt PRAC to Assess the Safety of Methotrexate
The Pharmaceutical Risk Assessment Committee (PRAC) has begun a review of methotrexate dosing errors. Mixups have occured for years as a result of the availability of methotrexate’s use in oncology and inflammatory indications, but countermeasures have failed to fully address the problem.
Methotrexate is taken weekly to treat inflammatory diseases. In cancer, higher, more frequent doses are needed. That has led to some inflammatory disease patients mistakenly taking the drug daily, not weekly. Some countries use visual reminders to cut the risk of dosing errors, but a review of adverse event data found patients are still overdosing, sometimes fatally, by mistakenly following the wrong regimen.
That finding led the Spanish drug regulator to ask EMA to investigate why dosing errors still occur and what can be done to stop them. The investigation has two parts. PRAC is analyzing reports of dosing errors in the EudraVigilance database and asking marketing authorization holders (MAHs) questions.
The questions task MAHs with calculating estimated patient exposure for their methotrexate drugs, scouring their databases for reports of inadvertent dosing and sharing details of their risk reduction initiatives. PRAC is interested in reports and initiatives covering both oral and parenteral formulations of methotrexate.
EMA’s committee is giving MAHs an opportunity to propose additional risk minimization measures and ways to monitor their effectiveness. These proposals and the evidence provided by MAHs will support PRAC’s recommendations.
ENVI Calls on Commission to Address Vaccine Shortages, Encourage Stockpiling
A European Parliament committee is calling for institutions to do more to stop vaccine shortages. The public health committee thinks the European Commission and member states must increase vaccine supply and availability to ensure the health of people living across the region.
Members of the Committee on the Environment, Public Health and Food Safety (ENVI) put forward the proposal in a motion for a resolution aimed at the European Council, Commission, nation states and the World Health Organization. The motion was prompted by a belief European efforts to expand the availability of vaccines and reassure citizens about their safety and efficacy are falling short.
Ensuring vaccines are available is one facet of the proposed strategy. Expressing concern at a shortages of vaccines, ENVI wants the Commission to make arrangements for stockpiling. To that end, ENVI gave its support to a joint procurement agreement. More than 20 member states have signed up to the initiative to pool their purchasing power and thereby ensure the availability of countermeasures.
Some of ENVI’s other proposals also have implications for how vaccines are regulated in Europe. The committee wants the Commission to consider creating a European Union platform for monitoring the safety and efficacy of vaccines. ENVI also floated the idea of strengthening the infrastructure used to collect data on infectious disease patterns to support the refinement of immunization programs.
Ireland’s HPRA Surveys Medical Device Industry About Impact of Brexit
The Irish Health Products Regulatory Authority (HPRA) is surveying the medical device industry about the anticipated impact of Brexit on their operations. HPRA is running the poll to identify challenges and opportunities that may arise as the UK leaves the EU.
The survey asks respondents whether they think Brexit will have a positive or negative effect on their operations, before delving into more specific implications of the change. HPRA wants to know how the industry expects Brexit to affect transport, customs, costs, supply and the size of the Irish market. The poll also seeks to understand the industry’s level of preparation and compliance concerns.
HPRA’s publication of the survey comes ahead of medical device information day next month. The event is primarily focused on the work HPRA is doing to implement new EU device regulations and the practical implications of the changes. However, HPRA has also set aside one hour to discuss how Brexit may affect the Irish medical technology sector.
The survey is open until 8 May. The HPRA event is scheduled for 23 May.
is revising its information on staff recruitment. The text, which was published 14 months ago, provides an overview of the agency and its personnel policy. EMA changed the status of the text to “under revision” this week but is yet to provide details of what information is changing or why. Recruitment Document
The SME Office
has published its annual report. The report shows requests to EMA
for regulatory assistance from small- and medium-sized enterprises (SMEs) ticked up again last year, rising 6% to 184. The rise is in line with the increase in the number of SMEs registered with the agency. Last year, the SME Office arranged 31% more briefing meetings than in 2016. EMA Report
’s working parties for patients and healthcare professionals have released their work plan for 2018 to 2019. The working parties will collaborate on topics including the availability of medicines and antimicrobial resistance. Each group will also work independently on some matters. Work Plan