Welcome to our European Regulatory Roundup, a weekly overview of top EU regulatory news.
Merck Accused of Blocking Remicade Biosimilars, Using Abusive Discount Scheme
The UK’s competition watchdog has accused Merck of running an abusive discount scheme to defend Remicade against biosimilar competition. Merck has a chance to respond to the provisional decision before the watchdog rules whether it has violated competition law and faces a fine.
Officials at the Competition and Markets Authority (CMA) have spent 18 months looking at how Merck priced Remicade in the UK after Celltrion introduced its biosimilar copy of the blockbuster anti-inflammatory drug. CMA’s provisional position is that Merck, specifically its ex-United States subsidiary Merck Sharp & Dohme, ran an anti-competitive discount scheme.
Merck denies it has breached competition law.
An anonymous source close to the case told Reuters how Merck allegedly deterred customers from switching to biosimilar copies. Merck is reportedly accused of offering discounts to customers that maintained their orders for Remicade at the same level after the introduction of biosimilar rivals. This would incentivise customers to only buy Remicade, rather than adding biosimilars to the mix or switching entirely to the biosimilars.
CMA could interpret such an incentive as a violation of UK competition law. If that happens, Merck could face a fine. CMA can theoretically fine companies up to 10% of their global turnover but this is more of a cap than a guidepost. Last year, CMA fined Pfizer £84.2 million ($109 million) and GlaxoSmithKline £45 million ($58 million). Neither case involved biosimilars. The GSK case is most comparable as CMA fined GSK for using pay-to-delay agreements to hold off generic competitors.
The Pfizer fine related to excessive and unfair pricing but was covered by the same aspects of competition law as the case CMA is bringing against Merck.
Press Release, Case File, Reuters
EU Public Health Committee Calls for Commission to Better Protect Whistleblowers
The Committee on the Environment, Public Health and Food Safety (ENVI) has called for Europe to strengthen the protection it offers whistleblowers. ENVI wants the European Commission to act to counter the perceived failure of member states to put protections for whistleblowers in place.
In a draft opinion, the European Parliament public health committee said it “deplores” the lack of action from member states. ENVI wants the Commission to propose a whistleblower protection directive to offset this inaction and ensure that people who come forward with information about businesses enjoy equal legal protection in all member states. The current lack of protection at the EU level means protection varies from country to country.
ENVI has inserted itself into the debate about whistleblower protection in the belief that failing to act may harm the implementation of EU policy in public health and other areas within its remit. The committee said whistleblowers play a “key role” in cutting risks to public health and that better protections will encourage more people from the public and private sector to come forward.
Other parts of the EU machinery will take responsibility for crafting the initial directive, if the idea is put into motion, but ENVI has sought to influence the process at this early stage by outlining its wish list for the policy.
“EU whistleblower protection legislation must be comprehensive and fast-acting and must protect the whistleblower and his or her colleagues and relatives from any kind of retaliatory action,” ENVI wrote in its draft opinion. “EU legislation should establish a clear procedure for handling disclosures from start to finish to ensure proper follow-through on the actions taken by whistleblowers, from report submission and processing to ensuring whistleblower protection.”
ENVI also wants the Commission to adopt a broad definition that covers all fields and affords the same level of protection to people working in the public and private sectors.
EMA to Redesign Early Dialogue Process for Pediatric R&D Plans After Failed Pilot
The European Medicines Agency (EMA) is planning to redesign its approach to early talks about pediatric development plans. EMA is making the changes in response to a pilot program that set out to encourage early dialogue but failed to have the anticipated impact.
Regulatory officials initiated the pilot project in 2015 to encourage applicants to discuss pediatric development plans very early in development. The goal was to define the appropriate conditions and pediatric target population. EMA thought getting sponsors to consider these topics earlier would lead to better integration of children and adolescents into the overall development plan.
However, minimal uptake of the offer of early dialogue means it is hard to gauge whether the idea works. EMA received 36 requests for early interactions. Three-quarters of these were for drugs that were so advanced their sponsors needed to submit pediatric investigation plans. This rendered the drugs ineligible for the early dialogue scheme.
EMA sought feedback on the pilot project at a meeting with trade groups including EuropaBio. The meeting identified a lack of clarity about the right time to seek early dialogue as a failing. Industry commentators also pointed to the need for a clearer picture of how early dialogue on pediatric development plans fits in with other interactions such as PRIME and the scientific advice process.
Despite the shortcomings of the pilot program, EMA left the meeting thinking the concept of early engagement has a future.
“Overall the opportunity for such interaction has been appreciated and deemed useful even though the scope and operations should be reconsidered and fine-tuned in order to meet expectations of all parties,” the agency wrote.
EMA now plans to redesign the program “taking into account that pediatrics need to be integrated into overall development programs.”
CHMP Rules in Favor of Paracetamol-Ibuprofen Combination in Safety Spat
The Committee for Medicinal Products for Human Use (CHMP) has ruled the benefits of tablets combining paracetamol and ibuprofen outweigh the risks. CHMP was called in to rule on the drug after Vale Pharmaceuticals tried to bring it to market through the decentralized procedure.
Vale filed for approval in the UK with a view to also bringing the drug to market in other EU countries including France and Germany. This led to a disagreement as some countries felt the rationale for short-term use without medical supervision was lacking. The risk of long-term use, choice of dose and extent of the data to support the use of the fixed-dose combination were also questioned.
The UK responded to the disagreement by referring the matter to CHMP.
After reviewing the evidence CHMP concluded the fixed-dose combination of 500 mg paracetamol and 150 mg ibuprofen is safe and effective. The ruling covers the use of the combination in adults, including the elderly. CHMP said the marketing authorization should be granted in all member states involved in the dispute.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted a warning about faulty defibrillators. MHRA’s alert affects LIFEPAK 1000 Automatic External Defibrillators. All 10,068 of the devices in the UK may suffer from a technical fault that renders them unable to deliver an electric shock to a person in cardiac arrest. Press Release, MoreEMA
has adopted a reflection paper on obtaining pharmacovigilance information about animal medicines from the internet and social media. The draft document triggered strong reactions, with one trade group raising “major concerns” about sourcing information from social media because of the “tremendous administrative burden” it will create. EMA Guidance