Transcript Fiona Godfrey: Public Health and the Internal Market, selected cases

The internal market and
health: selected case studies
Fiona Godfrey
EU Policy Advisor
ERS Brussels
What is the internal market?
Article III-14
• The internal market shall comprise an area
in which the free movement of persons,
services, goods and capital shall be assured
in accordance with the Constitution.
Key Treaty articles
•
•
•
•
•
Article 28 (non-discrimination)
Article 30 (defences to Article 28)
Article 49 (previously 59) (services)
Article 81 (competition)
Article 95
The four freedoms
•
•
•
•
Free movement of people
Goods
Services
Capital
Some principles of EU law
•
•
•
•
•
•
•
•
Ultra vires (lacking a legal basis)
Non-discrimination
Proportionality
Precautionary
Duty to give reasons
Freedom of expression
Right to property
Direct effect
Proportionality
Three tests applied to all EU legislation:
• What is the objective of the legislation?
• Are the means employed suitable?
• Do they go beyond what is necessary to
achieve the objective?
The different courts
EU (based in Luxembourg)
• European Court of Justice
• Court of First Instance
European Court of Human Rights
(Strasbourg)
Only ECJ and CFI can deal with questions of
free movement and EU Treaty law
How has the ECJ interpreted these
freedoms and principles in relation to
health?
BSE cases
Tobacco
Alcohol
GMOs and other potential risks to health
Patients rights
Drug authorizations
Drug pricing
BSE I
• 1998: a worldwide ban on sale of
British beef was proportionate and
justified because public health had to
come before pure internal market
considerations
France v Commission -BSE II
• May 2003 the ECJ annulled a Commission
decision ending the ban on Portuguese beef aimed
at combating BSE
• Asserted the need for a high level of protection to
be ensured in all Community policies
• Laid down specific tests Commission should have
carried out before lifting ban
• Found inspections did not take place or were not
sufficient to establish if ban could be lifted safely
Biret - Another beef case
• AG Alber Opinion May 2003:
• WTO law directly applicable in Community law
• Individuals (incl. Companies) have a fundamental
right to economic activity
• Where Community found to be in breach of its
responsibilities under WTO agreement and fails to
implement necessary legislation, affected interests
are entitled to compensation
Tobacco
• Tobacco I annulled 1998 comprehensive
tobacco advertising directive on ground it
was ultra vires because it did not meet its
legal objective of harmonizing the internal
market
• But AG Opinion seemed to accept
proportionality of a total ban had legal base
been valid
Tobacco II
• Upheld strict tests of Tobacco I to be met by all internal
market directives but
• As long as a directive has as its objective the improvement
of the Internal Market, “it is no bar that the protection of
public health (is) a decisive factor (in the directive)”
• Amendment of existing legislation does not necessarily
require new scientific evidence. Changes in perceptions or
circumstances can be sufficient
• Contrast that to
Snus case
• AG Opinion (7 September 2004) finds ban
on sale of oral tobacco legally based on
Article 95 but
• illegal for failure to give reasons AND
• Court should rule is illegal BUT maintain
the ban until Community enacts new
legislation to continue ban legally
Alcohol- Gourmet Foods
• National bans on alcohol advertising are in
breach of Article 28 EC but
• May be justified on public health grounds
under Article 30 unless the same effect
could be achieved by measures having less
effect on intra-Community trade
• National court left to decide - ruled
provision was disproportionate
Alcohol - Bacardi, July 2004
• The French ban on indirect TV advertising
for alcohol is a restriction on the freedom to
provide services but
• It can be justified on public health grounds
GMOs and potentially harmful
substances in food
• Monsanto C-236/01, September 2003
• A state can restrict or suspend marketing of
a product on precautionary grounds but not
on mere suppositions which are not verified.
States must give detailed reasons for
decisions of this nature
Denmark v Commission
• A Member State does not have to prove that it has a specific problem
in order to keep its existing legislation on potentially harmful
substances in food
• Where a specific problem does exist, the Commission should take
account of it
• No new scientific evidence is necessary
• Divergent assessments of risks can be made without the existence of
new evidence
• The Member State must prove that its existing legislation ensures a
higher level of health protection than the harmonising directive
• It must not be disguised discrimination
Patient rights: the erosion of prior
authorization
• Smits-Peerbooms 2001 - prior authorization can be
justified to maintain integrity of health care systems
• Cannot refuse if the treatment is tried and tested and the
applicant’s condition requires it
• Can only refuse if treatment can be provided without
undue delay at a facility recognized by the insurer/payer
Questions arising out of this ruling
• What constitutes undue delay?
• Does this apply to in and out-patient care
Muller Faure, 2003
• Confirmed that national laws requiring prior authorization can be in
breach of right to provide services
• Costs and risks of imbalances in health care provision can justify this
but
• Is a distinction between hospital and non-hospital care
• Reaffirmed Smits Peerbooms on hospital care but
• Went on to lay down factors to be taken into account to assess undue
delay e.g.. levels of disability, medical history, professional activity
etc.
• Found that on evidence provided freedom to provide services
precludes prior authorization for non-hospital care, even where
provided outside the country by a non-contracted provider
Ioannidis February 2003
• Pensioners can seek medical treatment in
another member state even if the condition
for which treatment is sought is not a new
condition, except where pensioner went to
the other member state exclusively for this
purpose (Articles 31, 36, 93 of Regulation
1408/71)
Leichtle, 2004
• National provisions concerning
reimbursement of travel, lodging etc. when
travelling abroad for a cure can be capable
of influencing patient choice
• This could constitute a barrier on freedom
to provide services
• A provision requiring greater prospects of
success abroad is discriminatory
Health rights giving rise to residence
rights- Zhu, Opinion May 2004
• A child’s right of residence cannot be based
on her status as a recipient of health or
childcare but
• If child is provided with private health care
it can enjoy the right of residence granted to
non-economically active individuals
• This confers a right of residence on the
parent
Drug authorization
Commission v Artegodan 2003
• ECJ confirmed CFI ruling annulling a
Commission decision to withdraw market
authorizations for anti-obesity drugs
• Authorizations had been granted according
to national procedures and not under EU
directives and Commissioned lacked legal
powers to withdraw the drugs
Drug costs- Doc Morris, 2003
• National provisions prohibiting sale of
medicines normally sold in pharmacies by
mail order can be breach Article 28 (EC)
• Article 30 can provide a justification but
only for prescription drugs
Drug costs - AOK, 2004
• Sickness funds fulfill an exclusively social
function and do not engage in competition
with each other
• Hence they are non-economic entities for
the purposes of Article 81 EC
• Accordingly, the competition provisions of
the Treaty do not apply to sickness funds
Charter of Fundamental Rights
• Article 3 - informed consent, sale of organs
etc.
• Article 8 - data protection
• Article 13- freedom of the arts and sciences
• Article 35 - right to health care
• We can expect to see EU legal cases arising
out of this when ratified
Summary
• Currently health protection measures founded on Article
95. Court will investigate legal basis for laws and uphold
health measures but only once internal market conditions
have been met (Tobacco I & II)
• Once met, Court prepared to give wide discretion to
Community measures and broad interpretation of
proportionate but
• This does not necessarily apply to Commission decisions
(Artegodan, Portuguese beef)
Summary II
• Court doesn’t like Community wide bans on advertising
(tobacco) but will accept Community wide bans on
specific products (BSE, Snus)
• Court will accept national advertising bans but only if
objective cannot be achieved with other measures
(Bacardi, Gourmet)
• ECJ has promoted patients’ free movement rights (Muller
Faure etc.) and rights to buy cheaper drugs (Doc Morris)
but
• Has ruled sickness funds not covered by competition rules
Summary III
• Where the Court can advance individual
rights without undue economic cost to
member states, it will (Muller Faure, Doc
Morris etc.) But
• Where extension of these principles could
seriously affect national health care costs, it
won’t (AOK)
Summary IV
• Precautionary principle accepted but good reasons
must be given (Denmark, Monsanto)
• Failure to give reasons increasingly cited as reason
for annulment
• Advocate Generals willing to be creative sometimes good (Tobacco II), sometimes bad
(Biret)
• Tobacco cases will always surprise us!