Dangers of Over-Regulation (or Under- Regulation) of Genetic Testing at EU level. David Barton
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1 Dangers of Over-Regulation (or Under- Regulation) of Genetic Testing at EU level David Barton Department of Clinical Genetics Our Lady s Children s Hospital Dublin
2 Background Diagnostic tests, known as in vitro diagnostic devices or IVDs Regulated at European level under the IVD Directive (1998) but translated into National laws IVD Directive is being replaced by an EU Regulation direct EU law
3 Dual Purpose The medical device regulations seek to ensure the safety, quality and performance of IVD medical devices They also seek to create a single EU market for IVDs an IVD approved in one EU state can be marketed in all EU states
4 CE Marking Award of the CE Mark indicates that a product or device complies with the relevant EU Regulations
5 CE Marking Award of the CE Mark indicates that a product or device complies with the relevant EU Regulations
6 The co-decision process...according to the EU
7 The co-decision process...in simple terms 1. Commission publishes proposal 2. Proposal is considered by European Parliament & working party of Member States amendments proposed to text 3. Aim to come to an agreed position on the text 4. Disagreements negotiated through a conciliation committee x
8 Scope to influence legislation Commission drafting proposals Parliament & Council negotiate
9 Scope to influence legislation We are here! Commission drafting proposals Parliament & Council negotiate
10 Scope to influence legislation We are here! Commission drafting proposals Parliament & Council negotiate Negotiations between Member States & MEPs highly political process - almost complete!
11
12 New Proposal
13 New Proposal Complete re-write of the legislation Medical devices and IVDs Public Consultations 2008, 2010
14 New Proposal Complete re-write of the legislation Medical devices and IVDs Public Consultations 2008, 2010 Proposal issued September 2012
15 New Proposal Complete re-write of the legislation Medical devices and IVDs Public Consultations 2008, 2010 Proposal issued September 2012 Many improvements on current IVD Directive
16 New Proposal
17 New Proposal Improved definitions Clear classification of all IVDs
18 New Proposal Improved definitions Clear classification of all IVDs Strengthened oversight of Notified Bodies
19 New Proposal Improved definitions Clear classification of all IVDs Strengthened oversight of Notified Bodies Increased role for Notified Bodies
20 New Proposal Improved definitions Clear classification of all IVDs Strengthened oversight of Notified Bodies Increased role for Notified Bodies Unique Device Identifier
21 New Proposal Improved definitions Clear classification of all IVDs Strengthened oversight of Notified Bodies Increased role for Notified Bodies Unique Device Identifier Identification of supply chain
22 New Proposal Improved definitions Clear classification of all IVDs Strengthened oversight of Notified Bodies Increased role for Notified Bodies Unique Device Identifier Identification of supply chain Improved transparency
23 NEW: IVD Definition extended in vitro diagnostic medical device means any medical device which is intended by the manufacturer to be used in vitro for the examination of specimens, for the purpose of providing information: concerning the predisposition to a medical condition or a disease to predict treatment response or reactions
24 Risk Classification All devices classified on the scale A (lowest) to D (highest) risk Set of rules for classification of each device Governed by manufacturer s intended purpose for the device If multiple rules or multiple purposes, highest classification applies Human genetic testing is Class C
25 Notified Body Involvement Class B and C devices: Notified Body checks the manufacturer s quality management system and, for class C, the technical documentation of representative samples. After initial certification, NBs will regularly conduct surveillance assessments in the postmarket phase.
26 Health Institution Exemption Current IVD Directive completely exempts tests made in a single Health Institution and used in that institution They are not considered IVDs Health Institution is not defined Tests used in a commercial context are not exempt. Changes in the new Regulation
27 Health Institution 1. An organisation whose primary purpose is the care or treatment of patients and which has the legal capacity to carry out such activities (NOT a commercial laboratory which provides diagnostic services) 2. Which makes/assembles its own test reagents, or modifies commercial kits
28 Health Institution Exemption Recital 9 To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices manufactured and used, including measurement and delivery of results, only within a single health institution should be clarified and strengthened.
29 Health Institution Exemption Recital 9 To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices manufactured and used, including measurement and delivery of results, only within a single health institution should be clarified and strengthened.
30 Health Institution Exemption With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions, provided that the following conditions are met:
31 New Requirements (aa) the device is not transferred to another legal entity, (a) manufacture and use of the device occur under appropriate quality management systems, (b) the laboratory of the health institution is compliant with standard EN ISO or where applicable national provisions, including national provisions regarding accreditation
32 New Requirements (aa) the device is not transferred to another legal entity, (a) manufacture and use of the device occur under appropriate quality management systems, (b) the laboratory of the health institution is compliant with standard EN ISO or where applicable national provisions, including national provisions regarding accreditation
33 New Requirements Justification of the use of a LDT is provided (the target patient group s specific needs cannot be met ) Annual reporting (on request) to CA including a justification of their manufacturing, modification and use General declaration on safety and performance (made public) Ongoing review and corrective actions
34 Hijack! Proposed Article on Genetic Counselling» Introduced and promoted by Peter Liese, MEP» 1. A device may only be used for the purpose of a genetic test if the indication is given by persons admitted to the medical profession under the applicable national legislation after a personal consultation.
35 Proposed Article on Genetic Counselling» 3. Information. Before using a device for the purpose of a genetic test the person mentioned in paragraph 1 shall provide the person concerned with appropriate information on the nature, the significance and the implications of the genetic test.
36 Proposed Article on Genetic Counselling» 4. Genetic counselling. Appropriate genetic counselling is mandatory before using a device for the purpose of predictive and prenatal testing and after a genetic condition has been diagnosed.
37 Proposed Article on Genetic Counselling» 7. A device may only be used for the determination of sex in connection with prenatal diagnosis, if the determination fulfils a medical purpose and if there is a risk of serious gender specific hereditary diseases.
38 phgfoundation
39 phgfoundation
40 phgfoundation
41 Success!» Proposals on Genetic Counselling rejected by Member States at Trilogue negotiations» Replaced (for political purposes) by benign proposals at MS level
42 Acknowledgements Stuart Hogarth, King s College London Martina Cornel, ESHG PPPC Will Greenacre & Stuart Pritchard, Wellcome Alison Hill PHGF Milan Macek
43 Acknowledgements Stuart Hogarth, King s College London Martina Cornel, ESHG PPPC Will Greenacre & Stuart Pritchard, Wellcome Alison Hill PHGF Milan Macek EuroGentest Network
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