I&EHL: EU Pharmaceutical
Law
André den Exter
Andre.denExter@ua.ac.be
Outline
• History
• Legal framework: Pharmaceutical chain
• Latest developments
1
History
- Thalidomide drama
- Pharmaceutical strategy (Directive
65/65/EEC)
- Divergence in interests between different
stakeholders
2
EU Pharmaceutical Policy: Regulating
the pharmaceutical chain
- From R&D towards using medicines:
R&D, clinical trials, patents, registration,
distribution, wholesale, packaging and
labelling, pricing, retail, advertising, and
privacy)
3
Legal Framework
• Public Health, Art 168 TFEU (4):
(c) measures setting high standards of quality
and safety for medicinal products and devices
for medical use.
• Pharmaceutical law (pharma chain)
• Internal market and competition rules
4
What’s a medicine?
5
What is a medical product?
Directive 2001/83/EC
Art. 1: presentation or function
CJEU case law: case-by-case approach
- Borderline products
- Differences in classification
Relevance
6
Research & Development:
Clinical Trials
• CTDirective 2001/20/EC
• Protection of clinical trial subjects
• Ethics Committee: pre-trial approval
• Notification adverse effects
• Good clinical practices
7
Manufacturing: Directive 2001/83/EC
Basic requirements manufacturing:
- Manufacturing authorization MS
- Labelling and package leaflet
- Classification
- Advertising and information
- Pharmacovigilance
8
Marketing Authorization
• Directive 2001/83/EC
• Regulation 726/2004/EC
- Art. 6: MA required to place a medicinal product
on the market, UNLESS…
• Compassianate use supply
• Pharmacy exemption (“Magistral formula”)
• Renewal of MA (art 24)
• Refusal of MA (art 26)
9
MA procedures
• National Procedure:
-
Application to national competent authority
Procedures governed by national law
Transparency
First step towards MR procedure
• Mutual Recognition/Decentralised Procedure
- Application to reference member state (RMS)
- Grounds for refusing to recognise RMS approval
- EMA Commission referral for arbitration
• Centralised Procedure
- Scope: high-technology medicinal products
- Application to EMA: Eur. Cie.
10
Specific procedures
• Orphan Drug Products (Reg.No 141/2000 (ODR)
-
Purpose
Community marketing authorisation
Market exclusivity (art 8)
‘breaking’ market exclusivity
Criticism ODR
• Medicinal products for paediatric use(Reg.1901/2006)
-
Purpose
Paediatric population
Paediatric Committee
Marketing Authorization requirements
11
Information and Advertising
(ART. 86-100)
• Complete harmonization
• Classification of products
• General/specific conditions advertising
• Latest regulatory proposal: information to
patients
12
Inducement: GSK vioxx training
course at Arabella Golf Resort
Mallorca
13
Retail sale: Pharmacies
- No harmonized rules (except for labelling/
leaflets and advertising)
- Only rules on classification
- Ownership, free movement, and public health
exception
- Infringement proceedings
14
Pricing
• Directive (89/105/EEC)
- Transparency pricing measures:
• Directly controlled price
• Use of international price comparisons: maximum
price
• Profit controls
• Not harmonised: Reimbursement
- Assessment of therapeutic benefits/clinical relevance,
cost-effectiveness and outcomes
- Positive and negative lists
- Reference price systems
- Co-payments, substitution and bonus system
15
Pharmacovigilance
• What is pharmacovigilance?
• Legal requirements pre- and post authorization
phases:
- 2001/83/EC and 726/2004/EU:
• Establishing pharmacovig. system MS (art 102)
• Qualified person and systems (art. 103)
• Reporting of Adverse reactions
- Spontaneous reporting
- Periodical reports all adverse reactions 104(6)
- Eudravigilance system
• Pharmacovig. inspections (art. 111)
• EMA’s role in pharmacovigilance
• Supervision and sanctions (art 116 )
16
Latest developments
• Legislative proposals:
- Tackle counterfeit medicines (Dir 2011/64/EU)
- Information prescription-only medicines
- Pharmacovigilance 2012 amendments
• Outsourcing/offshoring CTs in developing
countries
• Seizures of In-Transit Medicines
17