1. 6/26/2016Elena Georgieva11 SANCO C6 - Health Law and International PUBLIC HEALTH in the ENLARGEMENT PROCESS Promotion and protection of patients’ rights and access to health care 22 March 2010 Brussels

2. 6/26/2016Elena Georgieva2 Outline EU competence in Health Binding EU health law Key EU policies in health EU health law- Chapter 28 Role of DG SANCO Role of NGOs Public Health

3. 6/26/2016 Elena Georgieva 3 Public Health “Enabling good health for all” The EU aims to: Deliver a high level of health protection Promote healthier lifestyles Respond to disease outbreaks Encourage Member State cooperation on health Provide accurate health information and data Invest to tackle health inequalities Combat smoking through legislation and campaigns Deliver quality standards for blood, tissues, and cells

4. 6/26/2016Elena Georgieva4 EU Competence in Health Original Treaties focused on economics Occupational health, food safety Introduced in the Maastricht Treaty 1994 Article 129: Prevention and health promotion Developed by the Amsterdam Treaty 1999 Article 152: Broader scope and powers; subsidiarity Lisbon Treaty Article 152 TEC becomes Article 168 TFEU; adds cross- border cooperation; Charter of Fundamental rights

5. 6/26/2016Elena Georgieva5 TFEU-Article 168 1. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. Union action, which shall complement national policies, shall be directed towards improving public health 2. The Union shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action. It shall in particular encourage cooperation between the Member States to improve the complementarity of their health services in cross-border areas 3. The Community and the Member States shall foster cooperation with third countries and the competent international organisations in the sphere of public health.

6. 6/26/2016Elena Georgieva6 Binding EU health Law Communicable diseases Tobacco control Advertising ban, tobacco products, smoke- free environments Framework Convention on Tobacco Control Safety and quality of human substances Directives on blood and tissues & cells and policy for organs

7. 6/26/2016Elena Georgieva7 Communicable diseases Network for epidemiological surveillance and control of communicable diseases – Decision Early warning and response system for prevention and control of communicable diseases – Decision Community Network progressively covering communicable diseases – Decision List of communicable diseases and amendments as regards case definitions for communicable diseases - Decision

8. 6/26/2016Elena Georgieva8 Tobacco control Manufacture, presentation and sale of tobacco products - Directive Advertising and sponsorship of tobacco products - Directive Use of colour photographs or other illustrations as health warnings on tobacco packages – Decision Library of selected source documents containing colour photographs or other illustrations for each of the additional warnings listed in annex 1 of the Directive - Decision

9. 6/26/2016Elena Georgieva9 Blood and blood components Setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components – Directive Certain technical requirements for blood and blood components - Directive Traceability requirements and notification of serious adverse reactions and events – Directive Community standards and specifications relating to a quality system for blood establishments - Directive

10. 6/26/2016Elena Georgieva10 Tissues and cells Standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells – Directive Technical requirements for donation, procurement and testing of human tissues and cells – Directive Traceability requirements, notification of serious adverse reactions and evetns and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells - Directive

11. 6/26/2016Elena Georgieva11 Key EU health policy initiatives EU Health Strategy 2008-2013: Together for Health EU Health Program 2008-2013 European Pact for Mental Health and Well- Being EU Strategies on Nutrition, Overweight and Obesity Alcohol Rare diseases HIV/AIDS Global health European Partnership for Action Against Cancer Towards a Europe free from tobacco smoke Organ donation and transplantation: policy actions at EU level

12. 6/26/2016Elena Georgieva12 EU health Law- Chapter 28 For the purpose of accession negotiations, EU legislation- acquis- is divided into 35 chapters Requirements of EU health legislation- Chapter 28 “Consumer and Health Protection” Candidate Countries: Croatia: Chapter 28 was provisionally closed in December 2009 Turkey: Chapter 28 was opened in 2007, negotiations are ongoing former Yugoslav Republic of Macedonia- screening exercise still to start

13. 6/26/2016Elena Georgieva13 Support Potential and Candidate countries to transpose and implement EU health laws Participate in regular Subcommittee or Sectoral meetings and technical meetings Turkey- 19 January, Ankara Croatia- 06 May, Zagreb former Yugoslav Republic of Macedonia- 24-25 March, Skopje Serbia- 04-05 March, Belgrade Albania- 29 April, Tirana Montenegro- 25 May, Brussels Bosnia and Herzegovina- 02-03 June, Sarajevo Iceland- Role of DG SANCO (1)

14. 6/26/2016Elena Georgieva14 Monitor: Implementation of NPAA Progress on meeting the benchmarks Fulfillment of commitments of EUCP Provide input to: Progress Reports Questionnaire (recently sent to Montenegro, Iceland, Albania) NPAAs and European Partnership Reports Organisation of TAIEX workshops and projects financed by the Instrument for Pre- Accession Role of DG SANCO (2)

15. 6/26/2016Elena Georgieva15 Follow developments of EU health policy Become members of umbrella organizations Establish contacts with EU Delegations Meet with SANCO experts in Brussels or while on mission Provide position papers, share opinions, raise issues Monitor timely alignment with acquis in the country, signal delays and provide input to Progress Reports Participate in TAIEX workshops Role of NGOs

16. 6/26/2016Elena Georgieva16 Information SANCO Website http://ec.europa.eu/health Public Health Portal http://health.europa.eu EAHC Website http://ec.europa.eu/eahc/index.html

17. 6/26/2016Elena Georgieva17 Thank you! Elena.Georgieva@ec.europa.eu