A Medical Device Daily

Eucomed (Brussels) has been crafting a series of documents addressing a code of ethics for device makers, and the association recently proposed a procedural framework for deployment of ethical practices. As one might expect, the necessity of such a framework is triggered in part by the multiple national jurisdictions included in the association's coverage.

According to the Oct. 9 statement accompanying the framework document, the intent is to provide "an effective and efficient process to further align the medical technology industry on compliant practices and resolutions" as well as a consistent set of principles and "enforcement structures for Europe, building on the existing processes at [the] national level."

John Wilkinson, CEO of Eucomed said in the statement that nothing "is more important for our industry than to maintain public trust and safeguard integrity," and that the approval of the framework by the association "sends a strong signal that we take seriously our responsibility for legitimate and ethical business practices."

The code of ethics which the procedural framework addresses deals largely with relations between industry and physicians. According to the framework document, each national association is responsible for a code of conduct that will spell out "provisions for resolutions of disputes and the imposition of sanctions for breaches of its national code."

Eucomed also recommends that national associations set up a panel "designated to handle complaints," which the association "strongly recommends" be chaired by someone outside of industry. This recommendation for non-industry participants extends to the balance of a dispute resolution panel for "obvious reasons of independence, transparency and expertise."

The document also notes that while Eucomed will accept complaints related to incidents within a specific nation state, it will forward any such complaints "to the relevant member association." If a multi-national firm is the subject of a complaint, Eucomed will steer the complaint to the national association representing the firm's headquarters. Any complaints addressing a situation that is not covered by these provisions will be dealt with by Eucomed, which will assume "the right to impose sanctions" on the offending entity.

EMEA, FDA offer parallel advice

Firms that operate in more than one nation face a patchwork, but the European Medicines Agency (EMEA; Brussels) and FDA have opted to push a bit more toward a kind of harmonization – even if they disavow the concept in print – with a set of general principles on the subject of "parallel scientific advice." However, this function will apparently apply to only a limited set of therapeutic products, including nanotechnology.

According to the July 22 document, which EMEA posted to its web site last week, the objective is to exchange views "on scientific issues during the development phase of new medicinal products." The effort will hopefully lead to some regulatory clarity regarding breakthrough products and safety issues related to therapeutics for oncology as well as for pharmacogenomics. Also under consideration will be products such as vaccines, pediatric drugs and nanotechnology. A special emphasis is of interest for products for which guidelines either do not exist or for which the two agencies' guidelines "differ significantly."

The statement notes that a meeting between the sponsor, FDA and EMEA "usually occur[s] at the request of the sponsor," but "may be initiated by either EMEA or FDA." EMEA indicates that the 60-day timeline for such meetings with FDA is close to the typical 70-day timeline EMEA operates under, which should facilitate such meetings. The statement notes further that while most such meetings will be held via videoconference, the two agencies will consider a face-to-face meeting under some unspecified circumstances. However, regulatory decisions and fee schedules are unaffected by such consultations, EMEA notes.

EMEA warns sponsors that the idea of the meetings is to share information rather than "specific harmonization of study or regulatory requirements, although if harmonization is achieved, that could be a beneficial outcome." EMEA notes that any information submitted by sponsors pursuant to such meetings will be held in confidence.