Combination products in the European Union (EU) are currently regulated through two different arrangements. Combinations comprised
solely or mainly of pharmaceutical actives are controlled by medicines agencies while those consisting predominantly of devices
are approved through a fragmented national-based system based on certification by an expert organization called the Notified
Bodies. However, European politicians, non-governmental organizations (NGOs), doctors, and sections of the pharmaceutical
sector have been calling for the regulation of combination products to become more centralized. This approach would make it
more similar to the system in the United States where FDA approves combination products whether they are pharmaceuticals or
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The pressure for a more centralized approach has intensified after the European Commission proposed revisions to the existing
EU legislation on medical devices, with the aim of putting more emphasis on patient safety. The Commission suggested that
the European Medicines Agency (EMA) take a wider and more active responsibility for the scientific assessment of some in vitro diagnostic devices such as the companion diagnostic tests (CDTs). European Biopharmaceutical Enterprises (EBE) has cautiously
welcomed the Commission's proposal that EMA should participate in the assessment of clinical evidence on the scientific validity
of companion diagnostics.
"The proposed involvement of EMA in the assessment of companion diagnostics could prove beneficial, provided that the regulatory
obligations and research efforts to provide clinical evidence are not duplicated," says Titta Rosvall-Puplett, executive director
Members of the European Parliament and some NGOs want the Commission to be much tougher with devices outside the diagnostics
category by proposing the introduction of premarketing authorization (PMA) of high-risk or Class III products. This relatively
large group of medical devices would then have to undertake an approval procedure similar to that applied to pharmaceuticals.
Some EU member states, such as France, have hinted that they might support the idea of PMA for these devices. Inevitably,
EMA is seen by PMA supporters as the appropriate body to carry out premarketing approval based on data from pharmaceutical-style
preclinical and clinical trials.
"A premarketing authorization system for high-risk devices, such as that run by FDA in the US, is needed in Europe because
the safety challenges for these products is similar to those for medicines, and in some cases, the hazards could be even more
severe," says Monique Goyens, director general of the European Consumer Organization (BEUC). "You can stop taking a medicine
if something goes wrong, but with a deficient medical device, the patient may require surgery," she continues. "EMA has the
right infrastructure and experience to do the premarketing assessment work."
The medical devices sector, led by its main trade association Eucomed, has recognized that the legislation needs to be overhauled
after a number of scandals. The biggest of these scandals came to light three years ago after a leading French devices manufacturer,
Poly Implant Prothese (PIP), used industrial rather than medical grade silicone for making breast implants. The industry supports
the Commission's proposed introduction of higher safety and quality standards among the Notified Bodies. It also backs more
stringent requirements for clinical evidence to demonstrate the efficacy of higher-grade devices.
However, the medical devices sector is unhappy about the Commission's move to set up a central body of member state representatives—the
Medical Device Co-ordinating Group (MDCG)—to conduct an additional "scrutiny" procedure on risky devices. It is even more
concerned about any initiative to bring in PMA, especially if it is operated by EMA.
"What we want is a device-specific, effective, and predictable approval system that guarantees the highest safety for patients
without necessary delays, (and which is) specifically important for the highest risk class of devices," Serge Bernasconi,
Eucomed's chief executive, told a European Parliament workshop on the revised legislation in February 2013. He claimed that
a centralized approval system would not work for patients and the industry. He cited research conducted last year by the Boston
Consulting Group (BCG) showing that devices have been approved and made available to patients in Europe at least three years
before the same devices were approved in the US.