Euro Roundup: MedTech Europe warns Data Act poses ‘highly complex challenges’ for health sector

MedTech Europe is warning that applying the European Data Act to health care “brings unique and highly complex challenges” that must be addressed to prevent security, privacy and safety problems.

The European Commission proposed the Data Act early 2022 to provide “opportunities for the reuse of data” and to remove “barriers to the development of the European data economy.” The goals reflected a belief that “most data are unused” or “value is concentrated in the hands of relatively few large companies.” In June, the Commission reached an agreement on the Data Act with other EU bodies.

Through the legislation, the EU plans to enable consumers to access and share data generated by their connected devices. The provision prompted MedTech Europe and COCIR, another medtech trade group, to flag potential “implications on patient or device safety” if the obligation to share data contradicts the requirements imposed on medical devices by other EU regulations.

“In principle, we support the inclusion of the possibility for data holders and users to agree contractually on restricting or prohibiting access to data for security reasons, particularly if such processing might result in serious adverse effects,” the trade groups wrote in a joint statement. “With healthcare delivery remaining particularly vulnerable to harmful interference, it will be crucial to mitigate the increased risk of cyberattacks and other related threats.”

The trade groups are calling for “a possibility to restrict data sharing outside the confines of the secure and regulated sectoral framework ... , along with safeguards for protecting patients and hospitals from adverse impacts on the safety and security of highly sensitive data.” According to MedTech Europe, users may be unable to interpret raw data, raising the risk of incorrect diagnosis and treatment decisions.

Another section of the joint statement covers the protection granted by intellectual property rights and trade secrets. While welcoming the reference to EU and national intellectual property acts, the two trade groups remain concerned “that the Data Act could still have unintended and potentially detrimental consequences on a company’s ability to protect critical intellectual property assets and trade secrets.” A “rather narrow interpretation” of which data is readily available could help to mitigate the concerns.

“The high burden of proof for the data holder to ‘demonstrate that it is highly likely to suffer serious damage’ needs to be clarified and limited to a reasonable threshold. Despite the safeguards included, the scope of data sharing obligations under the Data Act is still very broad, which could put sensitive business information at risk, given the nature of data and trade secrets,” the trade groups wrote.

MedTech Europe and COCIR are also concerned about international data flows, noting the need to avoid “any risk of imposing data localisation and possible counter-reactions of third countries,” and want to see provisions to ensure interoperability and safeguards for international data transfers. Using existing health care standards such as HL7 could facilitate interoperability.

Joint Letter

EMA finalizes Q&A on transitioning to low global warming potential inhaler propellants

The European Medicines Agency (EMA) has finalized a question-and-answer document that discusses the data requirements for switching to low global warming potential (LGWP) propellants in oral pressurized metered dose inhalers.

EMA shared a draft version of the document for consultation earlier this year as part of work to address concerns about the environmental impact of some hydrofluorocarbons. The Commission wants to phase out the use of the molecules as excipients in inhaled therapies because of their effect on global warming. Companies have also asked EMA for scientific advice on replacing existing propellants with LGWPs.

The consultation process has resulted in changes to the draft. Most prominently, EMA has changed the title of the Q&A, swapping out “replacing hydrofluorocarbons” as propellants for “transitioning to low global warming potential” propellants.

EMA has made changes to the body of the document, too. The changes include the addition of a new subsection on risk management, in which EMA explains that major changes to the inhaler “may have impact on patient’s compliance, especially if the dose volume, pressure drop, taste and feel differ.” As such, “measures to benefit clear and smooth introduction” might be needed, “by reassuring the patients of equal benefit-risk, while explaining the environmental reason of this change.”

Elsewhere, EMA added a line to clarify that “production scale validation data should be provided unless there is appropriately justified that the manufacturing process can be considered standard for the particular manufacturer and manufacturing site.” The section directs readers to a guideline on process validation.

EMA Q&A

CHMP reverses position on Mirati’s Krazati, recommending approval after earlier rejection

Mirati Therapeutics’ attempt to overturn the EU’s initial rejection of its cancer drug Krazati (adagrasib) has paid off, with EMA’s Committee for Medicinal Products for Human Use (CHMP) recommending the KRAS inhibitor for approval after being asked to re-examine its original decision.

CHMP issued a negative opinion on Mirati’s request for conditional marketing authorization in July. The opinion reflected a belief that, while Krazati has a positive risk-benefit profile, the submission failed to meet the requirements for conditional authorization because Mirati was unable to show the cancer drug addresses an unmet need. Amgen’s rival KRAS inhibitor Lumakras (sotorasib) is already available in the EU.

Mirati argued Krazati is differentiated from Lumakras. Originally, CHMP disagreed, noting preliminary results on Lumakras that “cast doubt on the potential benefits of Krazati.” Further consideration led the committee to conclude that, while the molecules work in a similar way, there are differences between the medicines and the results of the Lumakras trial “are not necessarily relevant for Krazati.”

“CHMP also concluded that Krazati’s different safety profile and the fact that the medicine is taken by mouth provide advantages over the medicine docetaxel, which is given by infusion into a vein and is considered the standard of care for patients with [non-small cell lung cancer] whose disease worsened after previous treatment,” the committee wrote.

EMA disclosed the recommendation following a meeting in which CHMP offered support for the approval of other medicines. GSK received a positive recommendation for Omjjara (momelotinib), the myelofibrosis drug that it acquired in the $1.9 billion takeover of Sierra Oncology. Omjjara is a rival to Jakavi (ruxolitinib), an Incyte drug that is sold in Europe by Novartis.

EMA Notice, More

Brexit changes prompt Ireland’s HPRA to exempt dormant authorizations from fee increases

Ireland’s Health Products Regulatory Authority (HPRA) has decided against increasing the annual fees for dormant authorizations in light of changes to the Brexit situation.

Citing “the end of the Brexit exemptions and the introduction of the Windsor Framework,” HPRA told the industry it is keeping the annual fee the same “to help maintain those authorisations.” The Windsor Framework is the post-Brexit agreement that the EU and United Kingdom reached to address problems that the original deal created for trade with Northern Ireland.

HPRA disclosed the dormant authorization fee freeze in a notice about the conclusion of a consultation on the broader fee package. The need to keep the fee at the same level was not identified in the public consultation, which only received one response. The response, which was provided by a marketing authorization holder, voiced support for the general fee increase of 1.5% and other proposals.

HPRA Notice

Euro Roundup: MedTech Europe warns Data Act poses ‘highly complex challenges’ for health sector

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