Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work
The European Parliament’s health committee has renewed its call for the region’s drug regulator to be given more money and staff. ENVI, the Committee on the Environment, Public Health and Food Safety, made the comment in its opinion about the European Union’s 2020 budget proposal.
Pascal Canfin, ENVI’s rapporteur for the budget opinion, used the opportunity to comment on the 2020 budget proposal to hit a point that the committee has made repeatedly in recent years.
“Where appropriate, more financial and human resources must be allocated to those agencies in order to fulfill their mandate and execute their tasks, and in order to promote a science-based approach in the Union,” Canfin wrote in his final opinion on the draft budget.
The finalization of that headline comment on the budget came the day after ENVI voted on a series of proposed amendments to the EU’s financial plan. The proposals provided additional insights into the ways in which some members of ENVI think the EU is limiting the European Medicines Agency’s (EMA) ability to fulfill its functions.
Specific concerns raised by ENVI members include the perceived failure of the EU budget to account for the additional work created for EMA by veterinary medicinal product regulations that came into force in January.
“When the draft 2020 budget was proposed by the Commission, the impact on EMA of the Regulation was not yet fully established. EMA should be provided with sufficient human and financial resources in 2020 to prepare for the implementation of these new tasks,” five ENVI members wrote in a draft amendment.
Other members of the committee called for the EU to provide additional incentives for developers of orphan drugs, arguing that, “Patients suffering from rare diseases deserve the same quality of treatment as other patients.”
, Draft Amendments
UK Government Claims Brexit Will Enable Biopharma to ‘Innovate More Energetically’
Brexit will enable the United Kingdom to “innovate more energetically in pharmaceuticals and life sciences,” according to the government. The statement came shortly before parliament shut down for five weeks in a move seen by the prime minister’s critics as an attempt to thwart politicians who want to prevent a no-deal Brexit.
Speaking shortly before the temporary closure of parliament, Michael Gove, a senior member of the ruling Conservative party, talked up the positive effects of Brexit, without providing any detail about how the UK will realize these benefits in practice. Gove’s comments about the positive effects of Brexit for the pharmaceutical and life sciences industry were challenged in the House of Lords.
“That is the total opposite of what the pharmaceutical industry and the research sector have constantly said for the last three years,” Baroness Ludford said. “To achieve this disaster, the government are wasting £6.3 billion ($7.8 billion). Just think what could be done to improve the lives of British people with that money.”
Formal political debate about the government’s strategy and the creation of legislation to counter it is now on hold until parliament reconvenes on 14 October, a little more than two weeks before the UK is due to leave the EU.
Ireland’s HPRA Posts Series of Job ads to Build Pharmacovigilance Team
The Irish Health Products Regulatory Authority (HPRA) is hiring people to occupy several positions at its pharmacovigilance team, including the director of human products monitoring (HPM) post that it tried to fill earlier this year.
HPRA issued an advertisement for the HPM job earlier this year and gave interested parties until early June to apply. Now, HPRA has reissued the ad with a closing date of 30 September. The only other changes are a €2,000 ($2,200) increase in the annual salary and revisions to the application process, including the removal of statement about the need to complete a pre-interview exercise.
The reposting of the job ad comes months after HPRA failed to recruit a candidate for a medical device position in its the first attempt.
HPRA published the reposted HPM director ad alongside notices about availabilities elsewhere in the pharmacovigilance group. The Irish regulator is also seeking a vigilance assessment manager to work under the HPM director and a scientific officer focused on pharmacovigilance compliance.
, Vigilance Assessment Manager
, Scientific Officer
France’s ANSM Calls for Patient Advisor Projects to Support Regulatory Activities
The French National Agency for Medicines and Health Products Safety (ANSM) has published a call for projects involving patient advisors. ANSM envisions these people giving the patient’s point of view in its discussions about the regulations of medicines and medical devices in France.
To qualify for the ANSM initiative, a project must fall into one of several categories. ANSM is looking for projects designed to integrate patient partners into its operations, establish training programs for its staff or develop an interface between the agency and patients. Through such initiatives, ANSM aims to integrate the views of patients into decisions and thereby strengthen operation.
ANSM is accepting applications until 26 September. Projects accepted into the program will receive grant funding and run for up to one year. ANSM expects to decide which projects to fund by the end of next month.
EU’s SCHEER Posts Final Guidelines on use of Phthalates in Medical Devices
The EU Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has posted final guidelines on the benefits and risks of using phthalates in medical devices.
SCHEER finalized the guidelines after the European Commission held a public consultation on a draft version earlier this year. The final document details a methodology for performing benefit-risk assessments of the use of phthalates in medical devices. Phthalates can be carcinogenic, mutagenic, toxic to reproduction or endocrine disrupting but may be a better choice than the alternatives.
The guideline represents SCHEER’s current thinking on the topic, but it is cognizant of the chances that the situation may change over time. As such, the committee plans to evaluate the use of the guidelines and assess whether they are still useful every three years.
, Final Guidelines
government has said the National Institute for Health and Care Excellence
(NICE) will run a public consultation on cell and gene therapies in the summer of 2020. NICE plans to talk to patients and drug developers in the run up to the consultation, enabling it to go to the public next year with ideas about how to appraise the expensive, but potentially highly effective, drugs. Government Statement
The Dutch Medicines Evaluation Board
(MEB) has issued a notice about a risk of underdosing when using prefilled syringes of Novartis’
ocular disease drug Lucentis. The problem stems from difficulties moving the piston that pushes the drug out of the syringe. In some cases, that is leading to too little of the drug being injected into the eye of the patient. MEB Notice
government has said the Medicines and Healthcare products Regulatory Agency
(MHRA) has an IT system that it will implement to smooth the transition in the event of a no-deal Brexit. The government thinks the system, which MHRA has developed, will “sufficiently support” the UK biopharma industry through turbulence created by a hard split from the EU. Government Statement