Posted 15 June 2017
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
ENVI Urges Commission to Exclude Healthcare From Regulation of Professions
A public health committee has urged the European Commission to exclude healthcare jobs from changes to the regulation of professions. The Committee on the Environment, Public Health and Food Safety (ENVI) is worried the proposed legislation is “too complex to implement” and involves “too much red tape.”
The European Commission is planning to change its legislation to strengthen the comparability and transparency of regulations member states apply to professions in healthcare and other industries. Professionals with passports from the European Union can in theory move to any member state and start working. However, the patchwork of regulations countries and trade groups within them apply to different professions is fragmenting what should be a single market. This makes it harder for professionals to relocate and results in divergence in the quality of regulation across the region.
Officials tried to address the situation at the European Union level in 2013, but that directive has failed to deliver the desired outcomes. A mutual evaluation process established by the directive showed “regulatory decisions are currently not always based on sound and objective analysis or carried out in an open and transparent manner.” The commission has responded with a proposal intended to improve regulatory practices and their outcomes.
However, while ENVI understands why the commission wants to make the changes, it thinks they will do more harm than good in healthcare. Specifically, ENVI thinks the complexity and regulatory burden of the directive will hinder member states’ ability to deliver healthcare services. As such, the committee has proposed an amendment to exclude healthcare professionals from the bill.
“There is a need to ensure that the member states fulfill to the letter their responsibilities ... regarding the details of their health policies and how they organize the provision of healthcare services and medical care by dedicated regulated professions. In order to achieve this, such regulated professions should be excluded from the scope of this directive,” ENVI wrote.
ENVI proposed a second amendment to clarify the breadth of the exclusion for the healthcare professions. Another proposed amendment adds a line stating “people’s health and lives are of prime importance.”
ENVI Amendments, Draft Directive
EMA, FDA and PMDA Commit to Harmonization of Antibiotic Trial Subject Selection Criteria
Regulators from Europe, the United States and Japan are pushing ahead with plans to harmonize aspects of antibiotic clinical trials. The agencies committed to the process after identifying criteria for patient selection in trials of certain antibiotics as an area in which convergence is possible.
Officials at the European Medicines Agency (EMA) met with their counterparts at the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in April to discuss their approaches to the evaluation of antibiotics. That led to the identification of areas of regulatory convergence and an agreement that harmonization was possible.
EMA has now confirmed the agencies have agreed to align certain aspects of their requirements for the development of antibiotics. The agencies plan to update their guidance documents in line with this thinking. While that process is ongoing, the advice EMA, FDA and PMDA provide to individual drug developers will be in keeping with the agreements reached.
The confirmation of the program expands on EMA’s earlier report that it and its regulatory peers were interested in harmonizing requirements for treatments of urinary and intra-abdominal infections. EMA specifically wants to address the criteria for patient selection and response in these indications.
EMA’s summary of the meeting also brings up areas where the approaches of it and its peers are already similar. The agency highlighted clinical trial design recommendations and the endpoints for certain types of infections as areas in which similarities exist already.
The regulators think convergence can facilitate the development of new antibiotics, but there are areas in which their positions are currently too far apart to consider harmonization. EMA picked out “which endpoints should be regarded as primary in community-acquired bacterial pneumonia and skin infection trials” as an area in which differences remain. The agency hopes further talks and information sharing may bring the parties’ positions closer together.
Press Release, Meeting Summary, RAPS
PRAC to Reassess Opinion on Safety of Factor VIII Medicines at Behest of MAH
The Pharmacovigilance Risk Assessment Committee (PRAC) is reassessing its recent opinion about factor VIII medicines at the request of a marketing authorization holder (MAH). PRAC originally ruled the two classes of the hemophilia A medicine are similarly prone to inhibitor development.
That ruling is now up for debate again. PRAC’s re-examination procedure puts a new rapporteur and, if necessary, a new co-rapporteur in charge of the process. The intention is to examine the question anew to reach a recommendation independent of the earlier ruling. In some cases, such as the proposed suspension of diacerein in 2013, the re-examination can lead PRAC to reverse its original decision.
PRAC expects to complete the re-examination in time for its meeting at the end of August.
The process will dictate whether EMA treats factor VIII drugs derived from plasma differently from medicines made by recombinant DNA technology. PRAC’s original review found “no clear and consistent” evidence of different rates of inhibitor development between the two types of medicines. The review recommended updating the prescribing information of all products.
Netherlands Starts Consultation on Plan to Allow English Language Leaflets
The Dutch Medicines Evaluation Board (MEB) is seeking feedback on its plan to allow companies to use English language leaflets or text boxes in certain situations. MEB put forward the revisions to adapt its advice to the flexibility provided by EMA guidance on labeling and package information.
MEB is proposing to allow companies to bring products to market without Dutch language labels in certain exceptional circumstances. Examples of such circumstances include products needed by a small number of people and those with manufacturing processes that make it impossible to include labels in different languages. MEB cites radiopharmaceuticals as an example of a class of product with such a manufacturing process.
License holders that want to take advantage of this flexibility must send a request for exemption and a mockup of the English language packaging to MEB.
MEB is accepting feedback on the draft until 28 July. The consultation follows a discussion MEB held about its labeling policy earlier this year.
MEB Notice (both Dutch)
DePuy Synthes is recalling its radial head prosthesis system from the United Kingdom. The UK Medicines and Healthcare products Regulatory Agency (MHRA) disclosed the recall. DePuy issued a field safety notice about the devices late last year. Surgeons are advised not to implant the devices because of the risk they will loosen and cause damage to the bone or soft tissue. MHRA Alert
MHRA has told healthcare facilities to acknowledge the receipt of a field safety notice about Intersurgical’s Solus Flexible wire. Intersurgical issued the notice in March to inform people of the need to identify, quarantine and destroy all affected devices. MHRA wants facilities to acknowledge the field safety notice even if they have already complied. MHRA AlertGermany has confirmed is it is in the running to host EMA when the agency leaves London after Brexit. Reuters