1. Healthcare regulation: an obstacle to cross-border trade in services
Rita Baeten
European Parliament, 18 October 2017

2. Directive on a proportionality test before adoption of new regulation of professions
Assess whether the provisions are:
necessary to attain a public interest objective
suitable for securing the attainment of the objective pursued
do not go beyond what is necessary to attain that objective
Other Member States and interested parties may submit comments
42% are professions in the health and social sector
No specific approach

3. Focus is on regulation related to
reserving specific activities for professionals with a particular professional title
continuous professional development
language knowledge
rules relating to the organisation of the profession, professional ethics and supervision
compulsory chamber membership
registration or authorisation schemes
requirements limiting the number of authorisations to practice
fixing a minimum or a maximum number of employees holding particular professional qualifications
territorial restrictions

4. Background Jurisprudence of the Court of Justice of the EU (CJEU)
Proportionality test
Is a codification of the case law
But CJEU recognized specificity of health(care)
the fact that one Member State imposes less strict rules than another Member State does not mean that the latter’s rules are disproportionate
where there is uncertainty as to the existence or extent of risks to human health, a Member State should be able to take protective measures without having to wait until the reality of those risks becomes fully apparent
when there is uncertainty about the efficacy of alternative or less restrictive measures to protect public health, the inherent risks can be invoked to justify the maintenance of a measure

5. Proportionality test Assessment
Proportionality test is a principle of good governance
To counter:
Corporatist private interests
Protectionist national interests
But:
objective is not the proper functioning health system, but functioning of the internal market
Creates substantial legal uncertainty
Precautionary principle not applied

6. targeting regulation of (health)services
Context EU level policy initiatives
targeting regulation of (health)services
Context
Services Package
Simplify procedures for service providers
Proposal for a Proportionality Test
European standardisation of services
Healthcare Services Focus Group (HSFG)
International trade agreements
CETA, ...
Services Directive did not live up to expectations
=> Removal of obstacles for cross-border trade
=> Obstacles = regulation

7. Importance of regulation in healthcare
Access to healthcare is a fundamental human right
large investments of collective resources
From an economic perspective: market failures
Information asymmetry
Provider induced demand and ‘moral hazard’
Because the cost is mainly borne by a third public party.
Therefore:
Health systems are highly complex
Activities of health providers require extensive regulation
To ensure quality, access and the most cost-effective use of public financial resources

8. European standardisation of (health) services
Aims to compensate for deregulatory construct of internal market
Industry-driven
Voluntary, but can have legal effect
When used in contracts, accreditation processes, public procurement, referenced in legislation or in judicial proceedings, ..
Healthcare Services Focus Group (HSFG)
Goes far beyond technical specifications
Deals with requirements on:
healthcare facilities and premises, patients’ rights, insurance cover, pricing, billing, measurement, evaluation of clinical outcomes, who provides the healthcare service, where and how, human competences and training, the service structure: the professionals, departments, support services, communication, capacity planning

9. CETA Provisions applicable to healthcare regulation
Market access rules
Prohibition for rules limiting the number of service suppliers, the total number of service operations or the total quantity of service output
‘negative list’ approach: future new health services are not excluded from all the market access rules
Investment Court System (ICS)
could be used against any service regulations if it is considered to breach the ‘legitimate expectation’ of a stable business environment
‘ratchet clause’ and ‘standstill clause’
if a Member State has decided to liberalise certain aspects of its health system, it will not be able to reverse this decision

10. Conclusions
Regulation of healthcare providers is seen as an obstacle to the operation of the market
rather than as a way of ensuring access to healthcare, quality of care or the financial viability of health systems
Puts pressure on the capacity of health authorities to regulate healthcare providers
Creates substantial legal uncertainty
In particular future regulation is targeted
regulatory chill (e.g. e-health)

11. To know more