Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Ireland Joins Benelux-Centered Drug Price Negotiating Bloc
Ireland has joined a drug price negotiating alliance set up by Belgium and the Netherlands. Bringing Ireland into the BeNeLuxA Initiative on Pharmaceutical Policy swells the population it represents by 5 million, potentially strengthening its position in talks with drug manufacturers.
Belgium and the Netherlands founded the organization in 2015. Now, with Ireland on board, the bloc has five members that represent more than 40 million people. Together, the countries will try to get drug manufacturers to agree to lower prices than any of them could achieve alone.
“We live in a very small country with a population of about five million people,” Harris told the Irish Times
. “We’re joining an alliance that nearly has a population of 50 million people.”
That rationale has driven the alliance since its early days, when Belgium and the Netherlands got the initiative started by teaming up to negotiate drug prices. Since then, the integration of Luxembourg, Austria and now Ireland into the bloc has increased its collective bargaining power. Yet, the group is still waiting for its first agreement with a drug manufacturer.
Belgium and the Netherlands tried to reach a shared agreement with Vertex Pharmaceuticals about the price of cystic fibrosis drug Orkambi. However, negotiations broke down last year. Dutch officials subsequently independently agreed a price with Vertex.
The involvement of Austria, Ireland and Luxembourg should strengthen the bloc’s hand in future talks, as it can now offer drug manufacturers access to around 50% more people than before. However, the expansion could create administrative challenges for the organization. Belgium and the Netherlands are neighboring countries with a shared language. As the group expands beyond this base, it must account for more languages, divergent priorities and other complicating factors. Acting as a single, cohesive unit could become harder.
BeNeLuxA thinks the challenges are more than offset by the benefits of expansion, which extend beyond drug price negotiations. Alliance members also share information and collaboratively assess future health challenges. These activities should benefit from having access to more information and expertise.
, Irish Times
In a First, EMA Recommends Approval of Stem Cell Animal Medicine
The European Medicines Agency (EMA) has recommended a stem cell-based veterinary therapy for approval. The treatment for lameness in horses is the first stem cell animal medicine to receive the backing of EMA’s Committee for Medicinal Products for Veterinary Use (CVMP).
Global Stem cell Technology (GST) is seeking approval of the product, Arti-Cell Forte, as a treatment for horses with mild to moderate lameness caused by joint inflammation. The drug consists of stem cells that are taken from horse blood and processed to encourage them to develop into cartilage cells. Upon injection, the cells are designed to trigger the production of extracellular matrix and otherwise activate mechanisms that slow degradation of cartilage.
GST tested the idea in a six-week, placebo-controlled field study of horses suffering from fetlock joint lameness. The trial linked Arti-Cell Forte to a statistically significant improvement. The positive effect of the cell therapy was still evident one year later. Adverse events included mild increases in lameness, temperature and swelling in the week after administration of the therapy.
The overall dataset persuaded CVMP the treatment has a positive risk-benefit profile, prompting it to recommend a stem cell-based therapy for approval for the first time. Other cell therapies are likely to follow. The potential for regenerative medicines to counter the joint injuries that force sport horses into early retirement has attracted the attention of multiple research groups. Given the value of sport horses, there is potentially a significant market for drugs that address this medical need.
Denmark Targets 2019 Launch for National Drug Registry
The Danish Medicines Agency (DKMA) is targeting a 2019 launch for its national drug registry. DKMA took a step toward the goal this month by contracting Netcompany to build the IT system.
Danish officials want to establish the system to keep track of the drugs, companies and other details they need to monitor the sector and ensure patient safety.
To achieve those objectives, DKMA wants Netcompany to build the registry on a standard platform that uses the same terminology as systems across the European Union. This standardization and harmonization will equip the registry to exchange information with systems based elsewhere in the region, ensuring updates spread quickly.
DKMA will phase out its current drug registry once the new system is ready to use. Currently, DKMA is aiming to bring the new IT system online by the end of next year.
ABPI Reinstates Astellas Following Two-Year Suspension
The Association of the British Pharmaceutical Industry (ABPI) has reinstated Astellas Pharmaceuticals after a two-year suspension. ABPI suspended Astellas after finding the drugmaker had breached its code and knowingly given false information to the Prescription Medicines Code of Practice Authority (PMCPA).
ABPI’s statement is light on details, but the lifting of the suspension suggests Astellas has addressed the failings that got it into trouble. PMCPA, which enforces ABPI’s code, re-audited Astellas twice in the first year of the company’s suspension. After reviewing the findings, ABPI chose to extend the suspension by another 12 months. Astellas risked expulsion unless it showed significant progress.
The severity of the threat reflects the nature of Astellas’ wrongdoing. The investigation was triggered by a 2014 advisory board meeting that ABPI ruled was likely to discredit the pharma industry but soon spiraled out to cover other cases.
In assessing these cases, ABPI and PMCPA found a “total failure” of Astellas’ systems for controlling prescribing information. To compound matters, the review also accused Astellas of a “lamentable lack of concern for patient safety” and “initial lack of urgency.”
MHRA Posts Warning About Impersonator
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning about a person who is pretending to be a member of its staff. The person is pretending to work for the supplement unit at the United Kingdom regulatory agency.
MHRA’s notice about the incident states it will never contact people to provide medical advice or to sell or recommend treatments. The agency also advised people not to stop taking medications before discussing it with their healthcare professional.
The warning is the latest in a series of similar notices issued by the MHRA going back almost a decade. In 2015, MHRA alerted the industry to calls from someone who claimed to work for the agency. Six years earlier, MHRA issued a notice about a similar scam. Other regulatory agencies, including the United States Food and Drug Administration, have also contended with impersonators.
The Health Products Regulatory Authority
(HPRA) of Ireland has updated its guide to clinical trial applications. HPRA has removed a line that stated sponsors must submit lists of serious adverse events to ethics committees. The previous version told sponsors to send these line listings to the committees every three or six months. HPRA Guide
The European Commission
is looking for representatives of patient groups and clinicians who want to join EMA
’s Committee for Advanced Therapies
(CAT). CAT is seeking two patient representatives and two clinician representatives, plus alternates for them all, to replace its current civil society members. The chosen representatives will serve three-year terms. EMA Notice