Posted 21 September 2017
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Medtech Industry Pressures Brexit Negotiators to Maintain Existing UK-EU Relationship
Leaders from three medical device trade groups have called for the UK to retain close ties to the EU after Brexit. The letter asks negotiators on both sides of the Brexit process to keep the UK in the CE-marking regime and for its national regulatory agency to formally take part in the European Commission’s new Medical Devices Coordination Group (MDCG).
The CEOs of MedTech Europe, the Association of British Healthcare Industries and the British In Vitro Diagnostics Association made the requests in a letter to Michel Barnier and David Davis, who are, respectively, leading the EU and UK negotiating teams. At its heart, the letter is a call for the UK’s departure from the EU to result in a working relationship that looks a lot like the status quo. That puts the CEOs on the same page as their peers in the pharmaceutical industry and, to an extent, the UK negotiators who are pushing for a Brexit that changes little from a regulatory perspective.
To ensure stability in the medical device industry, the CEOs argue the negotiators need to get five factors right. The need for the UK to “remain an active part” of the CE-mark system “under a full implementation of the new Medical Devices and In Vitro Diagnostic Medical Devices Regulations” tops the list That request echoes one the industry made in a government-commissioned report last month but, in specifically arguing for the UK to fully implement new EU regulations, goes further than that document.
The four other critical stability factors follow the same line of thinking. The trade groups want the UK to have full access to the European Database for Medical Devices, EU-wide pre- and post-market data, registration of economic operators, details of clinical investigations and more, and for the Medicines and Healthcare products Regulatory Agency (MHRA) to formally participate in MDCG.
UK negotiators will see overlaps between the trade groups’ other two requests and the stance set out in their own position papers. The medical device groups want UK notified bodies (NBs) to remain EU-designated NBs and for UK-based entities such as authorized representatives and manufacturers to be classed as EU-based after Brexit.
The UK called for a similar arrangement in one of its position papers, and a government minister reiterated this position in a comment to parliament this week, saying the goal is to agree “the continued validity of existing market authorisations and compliance activity.” It is questionable whether this will happen, though. The European Medicines Agency (EMA) is telling the companies it regulates to prepare for a harder split.
The trade groups are concerned about the consequences of a hard split, arguing disruption would affect “the supply of devices and diagnostics critical to the delivery of modern healthcare, the maintenance of patient safety and the preservation of public health throughout Europe.”
Open Letter, Parliamentary Statement
UK Plans to Embed Switching in Policy Ahead of Herceptin, Humira Biosimilars
The UK is aiming to save £300 million ($405 million) a year by encouraging the adoption of biosimilars. Officials think such savings are possible if the healthcare system gets up to speed on the switching of biosimilars for innovator products ahead of the arrival of those for Herceptin and Humira.
In a framework for biosimilars, NHS England states “It is now important ... to embed the principles of switching to the best value biological medicine into commissioning and clinical practice.” The statement is a response to the opportunities for biosimilars to save the healthcare system money over the next few years. Specifically, NHS England is looking to biosimilar versions of Herceptin — the first of which was recommended for approval last week — and Humira to generate savings.
Factoring in those opportunities, NHS England thinks it can save £200 million to £300 million or more a year by switching to the best-value biologic. Responsibility for realizing this opportunity will fall on multiple players in the health care system. The framework lists how everyone from patients to commissioners can contribute.
In practice, NHS England thinks more than words of encouragement will be needed to drive the adoption of biosimilars, at least in the near term.
“NHS England supports the establishment of appropriate financial arrangements to incentivise the provider to implement processes to maximise early adoption and prescribing; for example this may include a departmental level incentive to cover the cost of staff resource used in facilitating a switch to biosimilar medicine,” the authors of the framework wrote. “Over time and once the practice of best value prescribing has been embedded, we would expect incentives to cease.”
Clinical commissioning groups, which are responsible for commissioning health services in their local areas, are expected to support the embedding of switching by proactively looking to increase the use of biosimilars. This will entail working with providers and doctors so they understand and use biosimilars when possible.
Commissioning Framework, Ontruzant Recommendation
EMA Establishes Process for Handling Long-Running GMP Non-Compliance Statements
The European Medicines Agency (EMA) has established a process for handling good manufacturing practice (GMP) non-compliance statements that are not lifted through a follow-up inspection. If the site is not re-inspected, EMA will add a note to EudraGMDP clarifying the situation.
EMA has introduced the process to avoid suggesting production plants have ongoing compliance problems. Under the previous model, this could happen if the issuance of a non-compliance notice to a site based outside the EU led to it being removed from marketing authorizations or filings. These removals would give EMA no reason to inspect the facility, leaving the company with no way to get the non-compliance statement lifted.
An inspection remains the only way a company can formally get a statement lifted. Now though, records in the EU’s GMP database will clarify that the presence of a non-compliance statement does not necessarily indicate the company has suffered from quality problems since it was issued.
EMA outlined the new process in an update to its question and answer document on GMPs.
EMA Seeks Feedback on Planned Changes to Multi-Strain Dossiers for Inactivated Vaccines
EMA has released a draft guideline on the data requirements for multi-strain dossiers for certain inactivated vaccines. The guideline covers vaccines against avian influenza, bluetongue and foot-and-mouth disease.
Members of EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) have rewritten the guidance to reflect the experience it and the companies it regulates have gained since the current version came into force in 2010. CVMP decided what changes to make by reviewing the issues raised by stakeholders.
The result is a draft guideline that sticks fairly closely to the current document. CVMP found only minor changes were required. These changes address some of the issues identified by CVMP. Other issues are covered in a new question and answer document.
CVMP’s three-page Q&A answers seven questions. The questions include whether it is possible to have different dose volumes for different target species and if there is a cap on the number of fixed combination products for a multi-strain dossier.
The draft guideline is open for comment until the end of March.
Draft Guideline, Draft Q&A
MHRA is running a survey to learn how it can better support the industry. The survey is open until 27 September. MHRA Notice