Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Accused of Appalling Treatment of Families in Pregnancy Test Review
A politician has accused the United Kingdom drug regulator of behaving “appallingly” to families who gave evidence to a panel that assessed the link between hormone pregnancy tests and birth defects or miscarriage.
The accusation against the Medicines and Healthcare product Regulatory Agency (MHRA) relates to the work of an expert working group (EWG) the government convened in 2014 to review evidence on synthetic versions of progesterone and estrogen that were used as pregnancy tests from the 1950s to 1970s, most notably a product called Primodos.
The EWG shared its findings in 2017, concluding that, “The scientific evidence does not support a causal association” between the drugs and adverse events. That failed to put the matter to rest, though.
Campaigners labelled the review a “whitewash” and called for a statutory inquiry into the evidence and whether there were regulatory failures. Those calls led to a debate in Parliament attended by campaigner Marie Lyon last week. Yasmin Qureshi, a politician in the opposition Labour Party, used the event to heavily criticize the EWG review and MHRA’s role in the process.
“The review was cloaked in secrecy from the very start. As an observer, Marie Lyon was forced to sign a ‘gagging clause,’ which, if breached, could have resulted in a prison sentence. Families who gave evidence to the panel reported being treated appallingly by the MHRA,” Qureshi said. “Despite the MHRA’s insistence that the expert working group was independent, two panel members had to be removed after Marie Lyon discovered conflicts of interest.”
Qureshi’s accusations and other aspects of the debate have implications beyond the question of whether Primodos is linked to birth defects and miscarriages. The Primodos case is one of the areas being reviewed in Baroness Cumberlege’s ongoing independent assessment of how the English healthcare system responds to patient reports about drug and device side effects.
The independent panel is yet to report its findings but some politicians already want to see major changes to drug and device regulation. Quoting an exchange involving Primodos campaigner Lyon, Qureshi alleged an MHRA official said that agency's job is “to represent pharma,” not patients, leading the Labour politician to question, “Why we are expected to have confidence in the independence of a review that was run by an organization part-funded by pharma?”
Jackie Doyle-Price, a government politician involved with the Department of Health, defended how MHRA is funded, but left the door open to changes intended to appease the concerns shared by Qureshi and others.
“It is entirely appropriate that regulators are funded by the community that they regulate, through fees. That in itself does not lead to questions on the regulator’s independence, but we need to offer some challenge in order to see whether the processes have sufficient integrity in terms of the response on issues of patient safety,” Doyle-Price said at the debate.
What that means for MHRA may become clearer when the ongoing Cumberlege review reports its findings. The review team is yet to commit to a deadline for publishing the report, but completed its six-month schedule of oral hearings last week, implying the evidence-gathering stage of the process is nearing the end.
, EWG Report
Dutch MEB Seeks Feedback on Patient-Friendly Translations of Medical Terms
The Dutch Medicines Evaluation Board (MEB) has revised its list of patient-friendly translations of the medical terms used in information leaflets and other product packaging. MEB now lists translations for 500 terms, up from 350, and is seeking feedback from the public on the revised list.
To expand the list, MEB sourced suggestions from groups, including its own staff, and enlisted Pharos, the Dutch center of expertise on health disparities, to test the terms and help it work toward a set of translations that patients understand. MEB has chosen translations that some people may think are very simple, the agency said, as research and experience shows many people misinterpret common terms, such as instructions to take two tablets twice daily.
Pharos ran the translations by at least five test subjects and shared them with an organization that analyzes texts from the perspectives of people who have difficulty reading and writing. The result is a set of translations MEB thinks are comprehensible to lay people, but it wants further feedback.
MEB is accepting public comments on the translations until 10 June.
Swissmedic Revises Guidance on Authorization of Complementary Medicines
The Swiss Agency for Therapeutic Products (Swissmedic) has revised its guide to the authorization of complementary medicines.
Swissmedic published the guidance at the start of the year to provide companies seeking simplified authorization of homeopathic and anthroposophic medicinal products with information about the required documents. Now, Swissmedic has updated several sections of the document.
The agency has added information to the section on declaration requirements. In the new guidance, Swissmedic states requirements for herbal substances apply to anthroposophic active substances from plant-based starting materials that are not manufactured according to a homeopathic process. Other new additions to the section include a discussion of the translation of active substance names.
Swissmedic has also added new information to a section on the information to include on containers and packaging materials. The guidance now states the information must be provided in at least two of Switzerland’s official languages and requests that all excipients are declared, regardless of the quantities present in the formulation.
EMA Publishes Policy on the Privacy of Staff Recruitment Candidates
The European Medicines Agency (EMA) has published a statement about the privacy policies that apply to job candidates. The statement explains how EMA collects and uses personal data provided by candidates at each stage of the staff selection and recruitment process.
EMA does not publicly share the names of successful candidates on the reserve lists, but members of its management team do have access to data relating to potential employees. The managers use the data, plus candidates’ application forms, for recruitment purposes. EMA also uses anonymized statistical information for human resource planning purposes.
Much of the information collected and analyzed by EMA comes from the candidates themselves, either through their applications or the responses they provide to written and oral assessments. EMA may also collect information on applicants from external, publicly available sources, such as social media accounts and websites.
How long EMA keeps the data depends on the success and seniority of the applicant. EMA destroys records related to unsuccessful trainee applications immediately but retains data about successful full-time candidates for five years after the expiration date of the reserve list.
’s Committee for Medicinal Products for Human Use
(CHMP) has recommended the approval of a long-lasting implant to treat opioid dependence. CHMP backed the buprenorphine device, Sixmo, as a substitution treatment for opioid dependence on the strength of clinical data showing 96.4% of patients responded to the therapy, compared to 87.6% in the active control arm. EMA Notice
has issued a warning about a shortage of long-acting oral anticoagulant phenprocoumon. The shortage relates to products supplied by Sandoz
. Supplies from Mylan
are available, but MEB thinks they may take a few days to be delivered by wholesalers. MEB Notice