Lecturing in Santander, UIMP

1. EU Health Law:
Recent Developments
Andre den Exter
denexter@bmg.eur.nl

2. Outline
• EU Human Rights Charter
• Public Health
• Patient Mobility
• Mutual Recognition Professional Qualifications
• e-Health
• Pharmaceuticals

3. EU Human Rights Charter
• Treaty of Lisbon: Charter on Fundamental HRs (1-12-2009):
– Content: Innovative approach
– Discriminatory approach: Art. 52(5) ‘principles’ incapable creating
directly enforceable rights
- General limitations clause: Art 51(1)
– Art 52(3): ‘materially incorporates the ECHR’ into EU law

4. EUCJ References EU Charter Fundamental Rights
and Health
• Art. 35 Health Care
ECJ C-444/05 / Opinion AG - Stamatelaki v NPDD – ECJ C-570/07,
C-571/07 / Opinion AG - Blanco Pérez – Case C-459/13 Siroka;
Case C-528/13
• Art. 17: Freedom of establishment. Case C-367/12 SokollSeebacher
• Protecting Biotechnological innovations and Human Dignity :
Patentability of human stem cells (hSCs),
– Brȕstle v Greenpeace (C-34/10)
– International Stem Cell Corporation v Comptroller General of
Patents (C-364/13)

5. EU Public Health Law: A Legal/Policy ‘Patchwork’
• Treaty on the Functioning of the European Union (TFEU): art. 168: Limited
powers blood, tissues, cells, organs, tobacco, cb health threats
• The ‘Organ Directive’ 2010/53/EU on standards of quality and safety of
human organs; organ tourism and ‘organ trafficking’, ActionPlan
• Tobacco Directive (2014/40/EU):
- EUCJ Philip Morris C-547/14: TD is Valid!
• Blood directive (2002/98/EC):
- Case Léger C-528/13: banning homosexuals from blood donation
• Association agreements and health
• ECDC: Decision 1082/2013 on serious cross border threats to health
• New Outbreaks: Ebola, Zika; What’s the response of the EU?: ECDC
Rapid Risk Assessment (Zika virus, update October 2016)

6. Patient Mobility
• Central question
• Part of right to health care, social ‘positive’ right
• ECJ/EUCJ: ‘negative’ right to seek medical care anywhere in the EU
• From Decker C-120/95) to Petru (C-268/13): lack of medication/
equipment, undue delay?
• Clash freedoms and finite resources
• Equity implications
• Legal framework: Directive 2011/24/EU: common principles:
- Continuity of care
- Excluded services
- Right to privacy
- Informed choice
- Reimbursement CBC
- National contact points

7. First analysis outcomes CBC Directive
- Data patient flows limited (MEMBER STATE DATA on cross-border
healthcare following Directive 2011/24/EU 2015)
- MS incorporated PA modalities: from “copy and paste” approach (Hr.)
to highly complicated multilevel decision-making process (It.)
- Potential discriminatory effect and overly complicated multilevel
approach discourages patients seeking CBC
- Challenged by Commission under Art. 258 TFEU, citizens CFR (Arts.
2, 21(2), 35 EUCFR
- NCPs: “web portal” poorly developed
- Tendency of ‘soft law’ harmonization combined with ‘hard law’
Directives: Implicit convergence European healthcare standards?

8. Professional Mobility

9. Facts and Figures
Foreign trained Foreign born Foreign
nationality
Poland 2.2% 2.9 0.6
Malta 17.4 9.0 8.9
Denmark 6.0 n.a. 6.1
Ireland 20.1 n.a. 33.0
Sweden 31.6 37.3 n.s.
Slovenia 3.2 11.2 8.1
PromeTheus 2008

10. Wismar (2008)

11. Legal Framework: ‘new’
• Directive 2005/36
• Scope: Establishment & Temporary stay
• Underlying principles
- Automatic recognition (AR) regulated professions; alternative regimes
- Mutual trust
- Language requirement
- Mutual assistance MS/ National contact points
• ‘Third country diplomas’: compensatory measures
• Exchange information ‘Problem doctors’
• Excluded: CB telemedicine: ‘country of origin principle’; licensing

12. Dutch ‘Dentist of
Horror’
• Alleged ‘dentist of
horror’ goes on trial
in France for
mutilating mouths
• 8 March 2016

13. Bad apples travelling?
• Public media from EU member A found a male doctor from that
country working in EU member B, even though the doctor, by order of
the regulator of A, had been stricken from the register.
• It is unclear how and when the physician could register in country B
but possibly he had done so already before legal measures were
taken in country A.
• Even more unclear is why the employing hospital had not checked the
register.
• How do registers communicate?

14. Latest changes: Directive 2013/55/EU
• European Professional Card (2013/55/EU)
• Alert mechanism

15. What remains......
• Diversity in requirements for continuing professional development
(permanent education)
• Diversity in disciplinary/professional standards assessing “fitness to
practice”
• Freedom to establish (Hartlauer C-169/07 and others)
• Free movement of students: Setting quota (75:20:5)
• Managing the ‘Brain drain’

16. e-Health

17. e-Health
• Heterogeneous concept
• Crossborder telemedicine services and national rules:
- Confidentiality
- Professional / deontological rules
- Liability for defective products, services, malpractice
• Solution: Dir 2011/24/EU, art. 4
• Patients’ Rights: MS of Treatment
• Reimbursement, rules and conditions

18. e-Prescriptions
• Art. 11: Interoperability ePrescriptions:
• Advantages
• Accessible to health providers, patient and HIF
• Information & comparing prescription behaviour
• Fully operational in Scandinavian countries
• Directive 2011/24/EU:
- Mutual recognition cb prescriptions
- Exceptions
- Interoperability ePs

19. EHRs
• Cross-border transfer EHRs (2014):
- Majority no legal rules CB interoperability EHRs
- Few legal/policy initiatives CB transfer

20. Internet Pharmacies
• Cross-border sale of medicines; towards an open EU
online market?
• Risks of online selling pharmaceuticals
• Prevention risks
- Counterfeit Directive (2011/62/EC)
- Buying medicines online: common EU logo (Art 85c,
Reg. 699/2014)
• Unsolved issues
• ECJ/EUCJ Case law selling online medicines: DocMorris,
Ker-Optika, and Pierre Fabre

21. eHealth: The Future
• eHealth: new dimension health care relationships; how does this affect
health law; patients’ rights?; initial steps Dir. 2011/24/EU
• Public Health Information Systems:
- Data linkage advantages and accuracy results of public health monitoring
and surveillance;
- Facilitates immediate action (tailored for control of disease outbreaks,
eg Ebola), spread of epidemics, isolation & quarantine
Is privacy protection balanced with public health needs?
• mHealth applications in resource-limited settings (HIV care, malaria, tb,
childhood vaccinations, non-communicable diseases, maternal health,
etc)

22. Unresolved issues
• Subsidiarity Principle
• In-person examination ‘first encounter’ conditional for reimbursement:
barrier to free movement
o Justification
• Second e-Pinion: idem
• New inequalities digital illiterated persons
• Cross-border transfer data EHRs
• Third country e-health services (telemedicine consultations); liabilities

23. Pharmaceuticals

24. What is a medicinal product?

25. EU Pharma law: Recent developments
• Tackle counterfeiting life-saving medicines: Directive 2011/62/EU
• Distance selling and European Logo (Art. 85c)
• Rare diseases and Directive 2011/24/EU
• Pharmaceutical Sector Inquiry monitoring reports
• Fixed retail prices PM violates EU law (CJEU C-148/15)

26. Discussion
• Outsourcing CTs in developing countries
• How to regulate online sales medicines (prescription only)?
• Direct-to-consumers advertising

27. Literature
• A. den Exter et al, ‘One Year after the EU Patient Mobility Directive: A
Three Country Analysis’, E.L.R 2(2015) 278-292
• A. den Exter, ‘Embryonic stem cell patents at European top court’,
EJHG (2015)1; doi:10.1038/ejhg.2015.98
• A. den Exter, ‘ Homosexuals and blood donation: A delicate issue for
the EU Court of Justice’, Blood Transfus DOI10.2450/2015.0155-15
• Commission report on the operation of Directive 2011/24/EU on the
application of patients’ rights in cross-border healthcare: COM(2015)
421 final
• European Commission Green Paper on mHealth COM(2014)219 final
• Jean Monnet project:
http://www.bmg.eur.nl/english/research/eu_projects/jean_monnet_pro
gramme/

28. JEAN MONNET PROJECT
A Distance Learning Course: EU HEALTH LAW
• Method: MOOC & Open Access via web
• Moot courts & Field visits
• Guest Lectures
• Language: English
• Content
• Start: February 2017
• Registration: DENEXTER@BMG.EUR.NL