Most pharmaceutical executives breathe a sigh of relief when they hear that discussions in Brussels on the regulation of medical devices are becoming ever more complicated. "Thank heavens I don't have to deal with all that" is a common response, with only a half-sympathetic glance towards their colleagues laboring in what is one of the junior partners in the business of European healthcare.
Think again. The shockwaves of the current European Union debates on devices are likely to echo through more and more of the medicines business over the coming years. So the message to drugmakers is relax and take that extra breath while you can.
Those with scant knowledge of the medical devices sector should start here. The European Parliament's health committee is scheduled to come to a consensus view on the two major regulation proposals launched last year by EU officials—one on devices, and one on in vitro diagnostics. This month, the full parliament is due to agree on its definitive opinion on the proposals, taking account of the health committee's thinking. And before the end of the year, governments of the Europoean Union's 28 member states are expected to finalize their position on the proposals too. So in all likelihood, in early 2014, new rules should be signed off that will change the face of EU controls on these products.And why should anyone other than the manufacturers of hip replacements or home blood-pressure monitors care? There are three good reasons. One is the wide scope of the legislation. Another is the atmosphere in which the new rules are being discussed. And the third is how all this is related to the progress of medical science.
As to the scope, much more than the proverbial prosthetic hip is covered. The new legislation on devices will bridge the gap between devices and advanced therapies, by introducing rules that cover products manufactured from non-viable human tissues or cells or their derivatives when they undergo substantial manipulation (such as syringes prefilled with human collagen). Rules will be tightened for products containing viable biological substances that are to be ingested, inhaled, or administered rectally or vaginally.
The new rules on in vitro diagnostic medical devices specifically legislate for tests that provide information about the predisposition to a medical condition or a disease (such as genetic tests) and companion diagnostics—tests providing information to predict treatment response or reactions.
And overall, new requirements are envisaged on author-ization, identification of suppliers, product information, traceability, pre-market clinical evaluation and post-market clinical follow-up, and surveillance, with manufacturers required to nominate a "qualified person."
The prospects for introducing reasoned and reasonable updates to the EU's earlier legislation, some of which is more than 20 years old, might not have been so delicate if the context had not been contaminated by the PIP scandal that coincided with the genesis of the new measures. But, as the European Union admitted when it made its proposals last year, the existing regulatory framework has "come under harsh criticism, in particular after the French health authorities found that a French manufacturer (Poly Implant Prothèse, PIP) had for several years apparently used industrial silicone instead of medical grade silicone for the manufacture of breast implants contrary to the approval issued, causing harm to thousands of women around the world."
PIP may have had nothing to do with the world of pharmaceuticals, but it certainly had plenty to do with the rigor that marked the regulatory proposals for devices and diagnostics, and the vigor that characterizes the debates around them. This is why the proposals are prefaced with abundant allusions to the regulatory framework failing to keep pace with scientific and technological progress, and to "gaps or uncertainties" over some products. And that is why the proposals aimed to put in place "a robust, transparent, and sustainable regulatory framework," and to "overcome the flaws and gaps" and strengthen patient safety.
It is also why the European Parliament's health committee is having to work its way through 399 proposed amendments on diagnostics, and through 907 amendments on devices. The changes the parliament is examining range widely, from attempts at clarification ("in some cases it is difficult to distinguish between medical devices and cosmetic, medicinal or food products") or enhanced transparency ("adequate levels of access for the public and healthcare professionals...on medical devices that may pose a risk to public health and safety is essential") to new regulatory procedures: "A swift centralized marketing authorization procedure should be introduced for innovative implantable devices, for innovative devices which incorporate, as an integral part, a substance which, if used separately, would be considered to be a medicinal product, with action ancillary to that of the device, for innovative devices intended to administer a medicinal product, and for innovative devices manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable."