PharmExec Blog

Europe: New Device and Diagnostics Legislation Could Shake Up the Drug Industry

EuropeEU-flag2EU-flag2New Device and Diagnostics Legislation Will Shake Up Drug Industry
The shockwaves from the current European Union debates in Brussels on medical devices are
are likely to echo through the medicines business over the next few years.
This month, the European parliament’s health committee will reach its view on the two major proposals launched last year by EU officials — one on devices, and one on in vitro diagnostics. In October, the parliament as a whole is due to agree its definitive opinion on the proposals. And before the end of the year, the governments of the EU’s 28 member states are expected to finale their position on the proposals too. So by early 2014, new rules should be signed off that will change the face of EU controls on these products.
But why should anyone other than the manufacturers of hip replacements or home blood-pressure monitors care? 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 intimately related to the progress of medical science.
As to the scope, much more than prosthetic hips are 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 authorization, 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 might not have been so delicate if the context had not been so contaminated by the French Poly Implant Prothèse (PIP) scandal that coincided with the genesis of the new measures. 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 vigour 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.
In his draft report on the proposals on diagnostics, German physician and MEP Peter Liese has also urged particular attention to companion diagnostics, and is insisting that they should comply with the new rules. He is advocating further toughening up of the rules, because in vitro diagnostics, far from being the poor relations of the medical sector, “may be the parents of all therapies, including pharmaceutical products and surgery”. He also points to “the huge opportunity of personalized and stratified medicine” that this opens up. This “needs to be addressed properly”, and “needs to be further clarified.”
The clarification Liese calls for is long awaited – and not just in relation to companion diagnostics, but in relation to personalized medicine in general. But here pharma executives in Europe are still awaiting a crucial paper from the Commission, announced five years ago, but still not finalized.  According to the latest draft, in vitro diagnostics represent one of the principal hopes for promoting personalised medicine.
The paper, entitled “The use of ‘-omics’ technologies in the development of personalised medicine”, suggests major new opportunities for the treatment of patients in the European Union, with better targeted treatment, fewer medical errors and reduced adverse reactions. And it argues for greater attention to diagnostics, rather than merely focusing on therapies.
But without the benefit of the Commission’s final version of the paper, the debates on devices, diagnostics and the future of the drugs industry roll onwards.  And as they roll, they are likely to start rolling very soon across the paths of many pharmaceutical executives too.

The shockwaves from the current European Union debates in Brussels on medical devices are likely to echo through the medicines business over the next few years.

This month, the European parliament’s health committee will reach its view on the two major proposals launched last year by EU officials — one on devices, and one on in vitro diagnostics. In October, the parliament as a whole is due to agree its definitive opinion on the proposals. And before the end of the year, the governments of the EU’s 28 member states are expected to finale their position on the proposals too. So by early 2014, new rules should be signed off that will change the face of EU controls on these products.

But why should anyone other than the manufacturers of hip replacements or home blood-pressure monitors care? 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 intimately related to the progress of medical science.

As to the scope, much more than prosthetic hips are 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 authorization, 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 might not have been so delicate if the context had not been so contaminated by the French Poly Implant Prothèse (PIP) scandal that coincided with the genesis of the new measures. 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 vigour 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.

In his draft report on the proposals on diagnostics, German physician and MEP Peter Liese has also urged particular attention to companion diagnostics, and is insisting that they should comply with the new rules. He is advocating further toughening up of the rules, because in vitro diagnostics, far from being the poor relations of the medical sector, “may be the parents of all therapies, including pharmaceutical products and surgery”. He also points to “the huge opportunity of personalized and stratified medicine” that this opens up. This “needs to be addressed properly”, and “needs to be further clarified.”

The clarification Liese calls for is long awaited – and not just in relation to companion diagnostics, but in relation to personalized medicine in general. But here pharma executives in Europe are still awaiting a crucial paper from the Commission, announced five years ago, but still not finalized.  According to the latest draft, in vitro diagnostics represent one of the principal hopes for promoting personalised medicine.

The paper, entitled “”, suggests major new opportunities for the treatment of patients in the European Union, with better targeted treatment, fewer medical errors and reduced adverse reactions. And it argues for greater attention to diagnostics, rather than merely focusing on therapies.

But without the benefit of the Commission’s final version of the paper, the debates on devices, diagnostics and the future of the drugs industry roll onwards.  And as they roll, they are likely to start rolling very soon across the paths of many pharmaceutical executives too.

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One Comment

  1. Posted September 23, 2013 at 6:09 am | Permalink

    If the proposals are passed a number of changes that will impact regulation of IVD in EU will be introduced;

    1. The IVD Directive would be replaced by IVD Regulations. EU member states have interpreted and implemented the current directives in different ways, which led to different levels of patient and public health protection in the European Union and created obstacles within the single market. The draft EU Regulations, which are laws unto themselves and do not need to be transposed into law within each member state, as is the case for directives.

    2. The proposed Regulation introduces a new risk-rule based classification system based on the Global Harmonization Task Force (GHTF) classification rules which will impact the review requirement for all IVDs. Under the current IVD directive (98/79/EC), approximately 80% of IVD products are grouped in the self-certification class. In the proposed Regulation only 20% of IVD products will remain in the self-certification category, while a form of third-party premarket intervention will be required for the remaining 80% of products. All “human genetic testing” falls into class C. This will set a higher bar for device manufacturers than the current self-certification system. Manufacturers of Class C devices will have their quality management systems inspected by national Notified Bodies. This will make approval of IVD products more expensive, and slower.

    3. The exemption from the regulations for devices manufactured and used within the same health institution (LDT) is retained, but is now restricted to health institutions compliant with ISO 15189 or other equivalent recognised standard. Labs which are not accredited would only be allowed to use CE-marked tests.

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