Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Industry and Lords Criticize No-Deal Preparations as Potential Hard Split Nears
Members of the House of Lords have strongly criticized the United Kingdom government’s attempts to lessen the effect of a no-deal Brexit on the biopharma industry. Citing feedback from industry and the government’s own impact assessment, the Lords warned the mitigating actions risked making the situation worse by forcing a “clunky regulatory system with extra costs” on companies.
With the UK 15 days away from the Brexit deadline and politicians unable to agree on a way forward, the prospect of the member state leaving the European Union without a deal is real and growing. On Wednesday, Michel Barnier, the EU’s chief Brexit negotiator, summed up the situation by saying that “the risk of no deal has never been higher."
Hours later, British politicians voted against such a no-deal Brexit. Yet, unless they either coalesce around an alternative that is accepted by the EU — such as the twice-rejected withdrawal agreement — seek and get a delay or withdraw the Brexit request altogether, the UK will leave by automatic operation of law on 29 March anyway. Late Thursday, Parliament voted to delay Brexit until June, although it remains to be seen if the EU will agree to such a delay.
Businesses and the government have been preparing for that prospect for months, but there remain significant doubts about whether the mitigating measures will ensure the ongoing supply of medical products and smooth functioning of the life science industry.
Some of those concerns were articulated in a debate in the House of Lords prior to the second vote on the withdrawal agreement. The debates were focused on the contingency legislation proposed by the government to establish the Medicines and Healthcare products Regulatory Agency (MHRA) as a standalone regulator but veered into broader concerns about the impact of Brexit.
Lord Warner, who frequently advocates for the biopharma industry in the Lords, led the criticism of the legislation by noting that businesses have been given little time to digest and act on 416 pages of statutory instruments (SIs) proposed by the government.
“It is very clear that, despite the expertise and professionalism of the MHRA and the industry, they have been left with ludicrously little time to master a massive amount of new detail and system change. These SIs create a great deal of additional red tape and running costs. They have already taken funding and resources away from research and development, and, as the impact assessments show, this will continue into the future,” Warner said.
Warner backed up his argument with comments taken from the government’s own assessments of the impact of the SIs and a briefing provided by UK biotech trade group BIA. In its briefing, BIA said the industry does not understand the government’s “requirement for an additional UK-based quality assurance system to verify [qualified person] certification of investigational medicinal products” from the EU.
Warner went on to articulate the industry’s concerns with the government’s proposed approach to exclusivity, before addressing the consequences of the UK duplicating EU regulatory processes by quoting the impact assessment created by MHRA.
“It is likely manufacturers would seek to recoup these additional regulatory costs through price increases, which would affect NHS budgeting and spending choices,” the impact assessment states.
Representing the government, Baroness Manzoor responded to questions from Warner and other Lords but failed to allay their concerns. The government thinks it is on the right track, with Manzoor claiming, for example, that the approach to market exclusivity will “mitigate any risk of delays in innovative products being brought to the UK,” rather than delay filings as the industry argues.
, Impact Assessment
, ABPI Notice
EU Commission, EMA Set to Collaborate to cut Environmental Impact of Medicines
The European Commission has outlined plans to work with regulators to reduce the pharmaceutical industry’s impact on the environment. Officials hope the actions will stop medicines, particularly antibiotics, from entering the ecosystem via sewage treatment plants and other sources.
In its report, the Commission sets out six responses to the problem, two of which directly involve the European Medicines Agency (EMA). The Commission wants to work with EMA to emphasize the need for companies to submit completed environmental risk assessments as part of their applications for marketing authorization and to look into changing pack sizes and expiration dates to reduce waste.
The Commission proposed the regulatory actions, which apply to human and veterinary medicines, alongside other mechanisms to encourage change. One idea is for the EU to work with member states to adopt procurement policies that favor companies that adopt greener pharmaceutical design and manufacturing practices.
Collectively, the Commission thinks the actions will improve wastewater treatment, thereby stopping drugs from entering the terrestrial or aquatic environment, and tackle original sources of emission to reduce the levels of pharmaceuticals in wastewater prior to treatment.
Officials want to start work on enacting the recommendations immediately. The Commission picked actions that it thinks can be initiated and, in some cases, finished by 2020.
, Commission Communication
Incoming EU Medical Device Regulations Prompt Bard to Withdraw Products
The step up in clinical data requirements triggered by incoming medical device regulations has led C.R. Bard to withdraw its urogynecological mesh from the EU. Bard thinks the devices, which are the focus of regulatory investigations and thousands of lawsuits, are safe but commercially unattractive in light of the new rules.
Today, Bard’s mesh devices, like many implants, are categorized as Class IIb devices in the EU. That will change next year when the new EU medical device regulations come into force. The rules single out surgical meshes as a type of device that falls into Class III.
Manufacturers of devices moved into the high-risk Class III by the legislation will need to carry out clinical investigations of their devices unless they already possess sufficient data or are otherwise exempt from the requirements. That will require investment that Bard, a subsidiary of BD, thinks is better spent elsewhere.
The decision likely reflects both the cost of generating the clinical data and diminishing opportunities to generate a return on the outlay. The market for urogynecological mesh has contracted on the back of reports of complications in patients undergoing treatment for stress urinary incontinence and pelvic organ prolapse.
In the United States, which moved mesh devices into Class III in 2016, Boston Scientific and Coloplast are the only companies trying to meet the higher evidence bar needed to stay on the market.
, Corrective Action
Mortality Data Trigger UK Investigation Into Safety of Cardiovascular Devices
The UK has initiated a review of the safety of drug-coated balloon catheters and drug-eluting stents featuring paclitaxel.
Authorities around the world have scrutinized the safety of the devices since the publication of a meta-analysis last year that linked them to a higher mortality rate than non-coated balloons or bare metal stents. Individual manufacturers have posted data disputing the finding, at least as it applies to their devices, but concerns about the study’s implications remain.
The expert group convened by the UK will assess the meta-analysis and other data sources with a view to reporting its findings about the benefits and risks of the devices to MHRA within a few months. MHRA will use the report to inform its decision into whether to update its advice or take other regulatory actions.