Regulatory Focus™ > News Articles > Incoming EU Health Commissioner Lays out Plan for Pharma, Medical Device Sectors

Incoming EU Health Commissioner Lays out Plan for Pharma, Medical Device Sectors

Posted 09 November 2012 | By

The Commissioner-designate for the European Commission's Health and Consumer Protection agency, Tonio Borg, may not be scheduled to be sworn into office for some time, but he's already shedding light on how he plans to approach pending legislative and regulatory matters of importance to the pharmaceutical and medical device sectors.

In remarks prepared for a legislative hearing before the Committee on the Environment, Public Health and Food Safety (ENVI), Borg, Malta's Minister of Foreign Affairs and a lawyer by training, said one of his primary focuses will be on strengthening the EU's regulatory framework.

"An appropriate regulatory framework is of critical importance for certain key sectors of the EU economy, notably food, pharmaceuticals, medical devices, cosmetics and consumer protection in general," Borg wrote. "I would aim at taking a leading role in maintaining and developing these frameworks ensuring also that reforms improve competitiveness in these sectors, which are all the more important at a time when Europe is living through one of its biggest economic and social crises."

The health sector, in particular, will garner much of his attention, he said. While this would include health systems more generally, Borg said he would also aim " to ensure proper implementation of  the recently adopted laws on pharmaceuticals, and  to  work  together with the Parliament and the Council to pursue the review of the legislation such as on medical  devices or clinical trials, keeping in mind the paramount principle of patient safety."

Added Borg: "I am committed to ensuring that my policies are developed on the basis of sound regulatory practices and in particular independent scientific advice, broad stakeholder consultation, sound legal and economic analysis and strict respect of proportionality and subsidiarity."

Borg also praised his predecessors, noting that EU citizens benefit from safe products and relatively good health. Their ongoing projects, too, were a topic of discussion.

"There are a number of on-going legislative procedures covering proposals such as … cross-border health threats, clinical trials and medical devices which I will pursue actively," explained Borg. "While I fully acknowledge the sensitivities surrounding these issues, I am ready to provide all assistance to the Parliament so as to allow the adoption of these proposals during this Parliament."

Borg added that he planned to introduced a number of "important legislative proposals," including one on veterinary medicines, but did not provide specifics. He also said he planned to go above and beyond existing patient safety measures. "Building on the forthcoming report I would aim at working on a joint action plan with Member States [to address patient safety]," Borg added, noting that the "rising costs of health technology" was of particular concern to him.

Still, in an era of tight resources and fiscal austerity, Borg said much of his attention would be focused on enforcing existing laws and regulations. "Enforcement is essential to efficient policy making and even more so in times of limited  resources," concluded Borg. "I believe that we should look together at ways to step up enforcement and push for more effective redress systems including alternative and online dispute resolution as well as collective redress.


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