Brussels, 22 Apr 2004
WHO? Philippe Busquin, European Commissioner for Research
In collaboration with Eryl McNally, Member of the European Parliament (EP) and Vice President of the EP "Scientific and Technological Options Assessment" (STOA)
WHAT? A conference for stakeholders and citizens debating the 25 recommendations of the EC's Expert Group on the ethical, social, and legal implications of genetic testing
WHEN? 6 & 7 May 2004 (6 May, 9:00 – 7 May, 14:00)
WHERE? European Commission, Charlemagne Building
170 Rue de la Loi, 1040 Brussels, Belgium
On 6 and 7 May the European Commission is organising a conference to publicly discuss the ethical, social and legal implications raised by genetic tests in research and healthcare. The conference will be based on a report and 25 recommendations suggested by an Expert Group of the European Commission that has worked for over a year. European Research Commissioner Philippe Busquin, Mrs Eryl McNally, MEP, and other well-known international experts will participate in the policy debate regarding the 25 recommendations.
The Expert Group, chaired by MEP Eryl McNally, included NGOs (interested patient organisations), the pharmaceutical industry (Bayer, Genzyme, GSK, Novartis, Roche), scientists and representatives from different academic backgrounds (law, philosophy, ethics and medicine). In order to help achieve consensus they have looked into additional evidence from other experts in Europe and the US. International Organisations (OECD, UNESCO, WHO, Council of Europe, EMEA, the European Agency for the Evaluation of Medicinal Products) followed these hearings closely.
When the news about deciphering the human genome, the 'book of life', was announced, it was predicted that this step in scientific analysis could "banish inherited disorders, screen people for their vulnerability to diseases, tailor treatment to an individual's genetic make-up, create thousands of new drugs and extend the human lifespan" (BBC, June 2000). Today a number of genetic tests exist and soon they will be part of everyday healthcare systems. It is important that society has trust and confidence when new genetic testing capacities are being developed.
- Participation at the conference is still possible for citizens, stakeholders and journalists.
Conference programme
The conference programme is available below. Conference languages are English, French and German (simultaneous translation). For the 25 recommendations and further information on the conference, please see also the web-site at: http://europa.eu.int/comm/research/confe rences/2004/genetic/index_en.html.
Who should attend?
Participants from organisations interested or involved in genetic testing, such as the medical and scientific community, students, NGOs, patient and disabled people organisations, health insurance providers, industry, experts of law and ethics, public administrations, international organisations, the general public and journalists are invited to actively participate in the conference.
There will be no conference fee for attendance.
25 recommendations
Some urgent needs relating to genetic testing, as identified by the 25 recommendations, are given by below as examples. All 25 recommendations are available online at: http://europa.eu.int/comm/research/confe rences/2004/genetic/recommendations_en.h tm
Additional information for the press:
- Journalists can attend the entire conference.
- Interested citizens and representatives from stakeholder groups can also attend.
- Registration is necessary and can be done online at http://europa.eu.int/comm/research/confe rences/2004/genetic/registration_en.html .
Contacts
Barbara Rhode
Head of the Unit "Ethics and Science", Research DG, European Commission
Tel: +32.2.295 98 88
E-mail: Barbara.Rhode @ cec.eu.int
Maurizio Salvi
Secretary of the STRATA group
Policy officer, Unit "Ethics and Science", Research DG, European Commission
Tel: +32.2.299 11 79
E-mail: Maurizio.Salvi @ cec.eu.int
Media contact
Michael H. Wappelhorst, Press and information officer
Information and communication Unit, Research DG, European Commission
Tel: +32.2.298 75 75, Fax: +32.2.295 82 20
E-Mail: Michael.Wappelhorst @ cec.eu.int
The 25 Recommendations on the ethical, legal and social implications of genetic testing
Most urgent needs referring to genetic testing as identified by the 25 recommendations are given below:
Quality assurance
Genetic-testing services in Europe, while based on high-quality scientific know-how, tend to suffer from a high level of technical error and poor reporting. This is caused by a lack of structure, complementary processes and common objectives at the European level that provide quality services to all citizens. In the context of healthcare, a test should only be offered when it has been shown to perform reliably and when there is a sound medical reason to consider it. A system for the validation of tests should be established.
Rare Diseases
The Group acknowledges that few countries have instituted screening programmes for serious rare diseases. The Group suggests that an EU-wide network for diagnostic testing of rare genetic diseases be created and financially supported as a matter of urgency. For rare but serious diseases for which treatment is available, Member States should introduce universal neonatal screening as a priority.
Ethnicity and genetics
There may be differentiation of patient populations, based on ethnic groupings, with respect to genetic testing. Some genetic variants are more common in certain populations or groupsin the EU and elsewhere. Specific attention should be paid to such groups in the context of new test developments both to ensure fair access and to avoid stigmatisation or stereotyping. Specifically, genetic tests are inappropriate to determine ethnicity and must never be used for this purpose.
Data protection: confidentiality, privacy and autonomy
Public concern regarding genetic testing revolves, to some extent, around the fear of misuse of genetic data and inappropriate access to such data by third parties. Confidentiality and privacy with regard to all personal medical data, including that derived from genetic testing, is a basic right that must be respected. The individual has both the right to know and not to know. Affording legal protection in this field is of paramount importance and the existing EU Data Protection Directive provides an appropriate framework to protect personal data.
Social, cultural and economic consequences
Relatively little information is presently available at EU level on the impact of genetic testing on health systems and health economics. It is recommended that the European Commission funds more research relating to the impact of genetic testing on the social, cultural and economic aspects of healthcare provision.
PROGRAMME (see also: http://europa.eu.int/comm/research/confe rences/2004/genetic/programme_en.htm)
Thursday, 6 May, 8:30-18:00
8:30 - 9:30 REGISTRATION
9:30 - 9:55 SESSION 1, OPENING
SPECIAL ADDRESS
Philippe Busquin, Commissioner for Research
THE WORK OF THE EXPERT GROUP
Eryl McNally, MEP, Vice President STOA
TESTIMONY:
Hélène Tack, Association Française contre les Myopathies
Bill Albert*,Chair of the Norfolk Coalition of Disabled People
Helena Kääriäinen*, Family Federation of Finland
Debate & Summary
9:55 -10:55 SESSION 2
Genetic testing, a realistic picture
Chair: Octavi Quintana Trias, director for health research (DG Research)
GENETIC TESTING IN A MEDICAL AND RESEARCH ENVIRONMENT, DIFFERENCES AND SPECIFIC NEEDS
Klaus Lindpaintner, Roche Genetics, Hoffman-La Roche
Commentator: Arthur Caplan, University of Pensilvania
Debate & Summary
10: 55 - 11:15 COFFEE BREAK
11:15 - 12:20 SESSION 3
Biobanks and Pharmacogenetics
Chair: Marisa Papaluca, EMEA
GENETIC TESTING, BIOBANKS AND PHARMACOGENETICS
Anne Cambon-Thomsen (Rapporteur), Inserm
Detlef Niese, Novartis
Commentator: Eva Maria Engels, vice-chair German Ethics Council
Debate & Summary
12:20 - 13:10 SESSION 4
Informed Consent and genetic testing
Chair: Henk Ten Have, Director, UNESCO
ETHICAL IMPLICATIONS OF GENETIC TESTING: WOULD GENETIC TESTING NEED A NEW KIND OF INFORMED CONSENT? FROM COMPETENT INDIVIDUALS TO CHILDREN AND VULNERABLE PERSONS.
Jan-Helge Solbakk, University of Oslo
Commentator: John Harris, University of Manchester
Debate & Summary
13:10 - 14:30 LUNCH
14:30 - 15:30 SESSION 5: Data protection and privacy issues
Chair: Stefano Rodotà, former Chair Art.29 Working Group and EGE Member
DATA PROTECTION ISSUES, WHAT TO PROTEC AND AT WHAT LEVEL?
Henriette Roscam Abbing, University of Utrecht
Commentator: Spiro Simitis, President German Ethics Council
Debate & Summary
15:30 - 16:30 SESSION 6: Avoiding discrimination and genetic counselling
Chair: Alex Capron, WHO
GENETIC COUNCELLING AND HOW TO AVOID DISCRIMINATION BASED ON GENETIC DATA?
Alistair Kent, Director, Genetic Interest group
Commentator: Herman Nys, University of Leuven
DEBATE
16:30 - 17:00 COFFEE BREAK
17:00 - 18:00 SESSION 7: Civil society perspective
Chair: Rainer Gerold, Director "Science and Society", DG Research
RARE DISEASES, SOCIETAL ISSUES
Eric Wendel, European Patients Voice, Denmark
Commentator: Ludger Honnefelder, University of Bonn
Debate & Summary
18:00 - 20:00 COCKTAIL
Friday, 7 May, 9:00-13:30
9:00 - 9:15 OPENING
Welcome
Achilleas Mitsos, Director General, DG RTD
9:15 - 10:15 SESSION 8: Education, Information and Professional requirements
Chair: Fernand Sauer, DG SANCO
GENETIC TESTING AND EDUCATION
J. J. Cassiman, University of Leuven
Commentator: Ségolène Aymé (Inserm and Chair PPPC of ESHG)
Debate & Summary
10:15 - 11:10 SESSION 9: Regulatory Issues
Chair: Elettra Ronchi, OECD
GENETIC TESTING, WHAT NEEDS TO BE REGULATED?
Eric Tambuyzer, Chair Healthcare Board EuropaBio, Senior Vice-President, Genzyme
Commentator: Judit Sandor, University of Budapest
Debate & Summary
11:30 - 13:00 SESSION 10: Next steps?
ROUND TABLE with
STAKEHOLDERS: PATIENTS: N.N.; INDUSTRY: Heinrich Schulte, Endrokrinologicum Hamburg; ACADEMIA: Domenico Coviello, Policlinico di Modena
and
DECISION MAKERS:
Elettra Ronchi, OECD, Carlos De Sola, COUNCIL OF EUROPE, Marisa Papaluca, EMEA, Philippe Renaudière, DG MARKT, Barbara. Rhode, DG RTD
Debate
FINAL REMARKS FROM THE CHAIR OF THE GROUP
Eryl McNally, EP
* to be confirmed
Further information and registration
http://europa.eu.int/comm/dgs/research/i ndex_en.html
Item source: http://europa.eu.int/comm/research/press /2004/pr2204en.cfm