Should Regulation of Combination Products Become More Centralized in Europe? - While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval


Should Regulation of Combination Products Become More Centralized in Europe?
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

BioPharm International
pp. 16-17


The high-risk Class III products incorporate substances that would be classified as medical products if marketed separately but in a combination, they enhance the functioning of the device itself. This group includes intra-uterine contraceptives and devices such as the heparin-coated catheters and bone-cement containing an antibiotic. With improvements in combination technologies, the distinction between what is primarily a device or a medicine has become harder to determine. In Europe, there has been a growing number of Class III combination products in recent years, whereby the drug and device are so closely integrated that one cannot be considered to be clearly ancillary or supplementary to the other. Furthermore, the materials and active ingredients can affect the function of each other.

"Under the present system, this interaction between the drug ingredients and the device materials is not being properly analyzed or assessed," says Goyens. "It needs to be done by an independent body with a public health mission and not by the Notified Bodies without any public health mission."

Although EMA has not been openly touting the EU for a key role in the assessment of devices, the agency's executive director, Guido Rasi, spoke out in an interview with Reuters last year in favor of regulating devices "at the same level of science and attention as with drugs." The agency clearly wants to establish a strong position in the assessment of combination products in areas of innovative medicine, such as advanced therapies and nanomedicines in which drugs and devices are closely integrated.

EMA's committee for advanced therapies (CAT) already has an advisory group that acts as the Notified Body for certifying devices for gene and cell therapies, and tissue engineering. Last year, the agency started issuing public assessment reports (PARs) on pharmaceutical substances combined with biological devices. The reports included details of the safety and quality of the pharmaceutical while looking at the benefits of its integration with the biologics devices such as scaffolding.

Nonetheless, some observers doubt whether EMA has sufficient competence to assess both pharmaceuticals and devices, and the interactions between the two. "In my experience, people from pharmaceutical backgrounds can struggle with medical devices because of different approaches to the interpretation of the data," says Peter Rose, managing director of High Edge Consulting, Nottingham, England. "The device experts are much better at stepping up to the role of medicines assessment whereas with the pharmaceuticals specialist, it is the reverse."

There may have to be a compromise by incorporating elements of both centralization and decentralization without having to bring together expertise in pharmaceuticals and devices within one organization. "Evaluators of the drug and the device need to work more closely together with a sharing of evaluation data at some stage, but the evaluators do not necessarily need to be working in the same entity," says Marielle Fournier, director of Voisin Life Sciences Consulting, London.

Ultimately, the key decisions on the revised or recast legislation on medical devices will be taken by the European Parliament and the Council of Ministers of governments of EU member states. As the changes are unlikely to be approved until next year at the earliest, there is plenty of time for the centralizers and decentralizers to resolve their differences.

Sean Milmo is a freelance writer based in Essex, UK,

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