EU Regulatory Roundup: UK High Court Rejects Interpretation of EMA Powers

Regulatory NewsRegulatory News | 27 September 2018 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK High Court Rejects Interpretation of EMA Powers, Opening the Door to Avastin Use in AMD
The High Court in London has ruled that the National Health Service (NHS) can use Roche’s Avastin on an off-label basis to treat wet age-related macular degeneration (AMD). In siding with the NHS over AMD drug developers Bayer and Novartis, the judge stated that organizations other than the European Medicines Agency (EMA) can assess whether a drug is effective.
Bayer and Novartis took the case to the court after 12 regional NHS units adopted a policy that stated Avastin is the “preferred treatment option” for wet AMD. The NHS units based the decision on their assessment of the safety, efficacy and value of Avastin, Bayer’s Eylea and Novartis’ Lucentis. As Eylea and Lucentis cost around 29 and 20 times as much as Avastin per injection, the NHS units settled on Roche’s drug as the best option.
However, while clinical trials have found Avastin is as good as Lucentis in AMD, Roche has not filed for marketing authorization in the indication in Europe. As Avastin is not approved in AMD, Bayer and Novartis argued that there is no lawful basis for the supply of Avastin in AMD and that the policy of the NHS units undermined European legislation.
The line of argument led the court to consider the division of powers between EMA and national bodies. As Justice Philippa Whipple saw it, Bayer and Novartis argued that “EMA has exclusive competence to determine the safety, clinical efficacy and quality of medicines available to the public,” pointing to a European directive to support their case. Whipple dismissed the argument.
In issuing her judgment, Whipple called Bayer and Novartis’ claims about the supremacy of EMA “an absurd proposition,” adding that it would “give unbounded power to the pharmaceutical companies to decide which medicines to make available for which purposes. As the judge sees it, that is not what the law envisages. If interpreted that way, Whipple thinks the law would “be seriously detrimental to the wider public interest in maintaining a cost-effective public health system.”
Whipple’s decision to side with the NHS units over the limits of their powers undermined a key plank of the case made by Bayer and Novartis. Other points discussed in the court include the safety of Avastin in AMD and whether the compounding of the drug for intravitreal use creates an unlicensed medicine or is an off-label use of a licensed medicine. Neither line of argument persuaded Whipple to rule in favor of Bayer and Novartis.
The discussion in the court could lead to a change in how the Medicines and Healthcare products Regulatory Agency (MHRA) classifies Avastin, though. In 2009, MHRA referred to compounded Avastin as an off-label medicine. Two years later, MHRA changed its position. Whipple wants MHRA to reconsider its position. 
“It is not clear to me why the MHRA changed its view at this time. MHRA maintains an unexplained classification from seven years ago to the effect that CB is an unlicensed medicine,” Whipple wrote. “It is time the MHRA reviewed its position. I invite it to do so.”
The MHRA review could further weaken Bayer and Novartis’ argument. Whipple has already dealt it a serious blow, though. The judge rejected all four grounds on which Bayer and Novartis challenged the NHS units and dismissed their case.
Court Ruling
Switzerland Revises Rules to Facilitate Market Access, Improve Drug Safety
Switzerland is set to introduce new rules on market access and drug safety at the start of next year. The changes are part of a raft of revisions Switzerland has been working to introduce since legislators passed a new Therapeutic Products Act in 2016.
Some aspects of the revised legislation came into force at the start of 2018, but the implementation of other changes was held up by the need to amend the relevant ordinances. Having seen progress on the amendment process, the Federal Council has decided to implement legislative changes at the start of next year.
The changes affect the availability of over-the-counter drugs by empowering pharmacists to provide certain medicines without a prescription. Switzerland is also seeking to encourage pediatric medicine development by extending patent protection and improving its drug safety oversight mechanisms.
While the implementation of aspects of the revised legislation is progressing, Switzerland has had to delay other changes. The 2016 legislation includes changes to ensure physicians’ payments, discounts and rebates do not affect treatment decisions. However, a public consultation has revealed a need to conduct a major overhaul of the ordinances before the changes are implemented.
Swiss officials expect to bring the postponed changes into force in early 2020.
Swissmedic Notice, Modification Summary, Press Release (French)
EMA Says More Data Needed Before Wearables are Used as Primary DMD Endpoints
EMA has ruled that more data are needed before wearable-based assessments of stride velocity can be used as the primary endpoint in Duchenne muscular dystrophy (DMD) clinical trials. The draft ruling permits the use of such assessments as a secondary endpoint in pivotal and exploratory trials.
Officials at EMA considered the use of clinical data from ankle-worn wearables upon the request of a publicly unidentified applicant. The applicant proposed putting a watch-like device featuring sensors including an accelerometer and gyrometer on the ankles of DMD trial participants to capture data on their strides. Before going to EMA, the applicant cross-validated the measure with the widely used six-minute walk test (6MWT).
Replacing the 6MWT with a wearable-based assessment could result in data that better represent the effectiveness of an intervention. The results of the 6MWT depend on the patient’s motivation and condition at the time of the assessment. In contrast, a wearable-based system would assess the patient continuously, giving investigators insights into their day-to-day physical performance.
However, EMA thinks the technology is not ready for use in primary endpoints. EMA said the data are promising but it wants to see a stronger long-term correlation between the stride measure and functional tests. The agency is more amenable to the measure’s use in secondary endpoints, though.
EMA is accepting feedback on its draft decision until 30 November.
Draft Opinion
CVMP Posts Clutch of Draft Veterinary Medicine Regulatory Documents
EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a clutch of draft regulatory documents. The texts include a draft guideline on the summary of product characteristics (SPCs) for products containing antimicrobials.
CVMP’s SPC draft is intended to bring the guideline up to date with how thinking about antimicrobial resistance has changed since the current version of the document came into force in 2008.
The other two documents released for consultation are draft reflection papers. One of the drafts addresses the use of aminopenicillins and their effect on antimicrobial resistance. The second draft details current knowledge about resistance to ectoparasiticides. 
EMA is accepting feedback on the SPC guideline and the ectoparasite reflection paper until 31 August 2019. The aminopenicillin paper is open for comment until 21 December.
SPC Guideline, Aminopenicillin Paper, Ectoparasite Paper
Other News:
EMA has redesigned its website. The new design is intended to display better on mobile devices and make it easier to search for information. On the back end, EMA has moved the site to the cloud, a change it thinks will simplify aspects of its relocation to Amsterdam. EMA Notice


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Tags: EMA, NHS, Swissmedic

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