1. Law and the regulation of pharmaceutical products in South Africa
Socio-economic rights in the private sector:
Law and the regulation of pharmaceutical products in South Africa
Jonathan Berger
Senior researcher, AIDS Law Project
Visiting researcher, Georgetown University
Thursday, October 30th 2008
The World Bank
Washington, DC

2. Overview of presentation
Setting the context
Overview of key constitutional law developments
The impact of Polokwane
The Constitution and institutional reform
Implementing the Medicines Act
Overview of TAC and Another v Rath and Others
Outcome and implications for institutional reform
Amending the Medicines Act
Former Minister’s tabled Bill
Portfolio Committee (National Assembly) version
Select Committee (National Council of Provinces) amendments
Way forward

3. Key constitutional law developments
Constitutional provisions
Section 27
Expressly recognises a right to have access to health care services
Places positive obligations on the state in respect of this right
Section 7(2)
Requires the state to respect, protect, promote and fulfil all rights
Jurisprudence
Strength and limitations of constitutional protection
Health cases in particular reflect value of constitutional protection
Demonstrate link between successful rights-based legal action and civil society organisation, mobilisation and advocacy
Need to focus on institutional reform
Current successful approach is not sustainable in medium to long term

4. The impact of Polokwane
Pre-Polokwane
Executive dominance
Undue influence over “independent” authorities: e.g. NPA
Rubber-stamping Parliament
Scientific governance of medicines undermined
Uncritical promotion of traditional medicines and other untested drugs
AIDS denialism at highest levels of government
Post-Polokwane
Resurgence of Parliament
Health identified as priority for fourth Parliament ( )
Greater oversight of the exercise of national executive authority
Major amendments to tabled bills
Ousting of President Mbeki leads to mini Cabinet reshuffle

5. Constitution and institutional reform
Concerns relating to the health care system
Limited access to health care services across sectors
Chronically underfunded public health system
Inappropriately regulated private health care system
Relationship between public and private sectors unresolved
Need for independent and accountable institutions
Oversight institutions
Chapter 9 institutions
Parliament and the electoral system
Need for a National Health Authority
Regulatory institutions
Range of structures (statutory councils, departmental directorates)
Potential for executive interference
Lack of coordination between institutions

6. Overview of presentation
Setting the context
Overview of key constitutional law developments
The impact of Polokwane
The Constitution and institutional reform
Implementing the Medicines Act
Overview of TAC and Another v Rath and Others
Outcome and implications for institutional reform
Amending the Medicines Act
Former Minister’s tabled Bill
Portfolio Committee (National Assembly) version
Select Committee (National Council of Provinces) amendments
Way forward

7. Implementing the Medicines Act
TAC and Another v Rath and Others
Stop Rath from violating the Medicines Act
Selling unregistered medicines
Conducting unauthorised clinical trials
Publishing false and misleading advertisements about medicines
Compel state to act
Report to court on steps taken to stop Rath (structural interdict)
Outcome and implications for institutional reform
Largely successful (on four of five issues)
Rath’s medicines not yet subject to registration
Subject of counter appeal (against Rath, not the DoH)
Law enforcement to be part of DRA’s expanded mandate

8. Overview of presentation
Setting the context
Overview of key constitutional law developments
The impact of Polokwane
The Constitution and institutional reform
Implementing the Medicines Act
Overview of TAC and Another v Rath and Others
Outcome and implications for institutional reform
Amending the Medicines Act
Former Minister’s tabled Bill
Portfolio Committee (National Assembly) version
Select Committee (National Council of Provinces) amendments
Way forward

9. Former Minister’s tabled Bill
Weak authority as a line function within the executive
To replace “independent” Medicines Council Council
In defiance of Ministerial Task Team (MTT) recommendations
Without any internal governance structure
Broad inappropriate powers for Minister
Registration of medicines
Authorisation for use of unregistered medicines
Exclusions from operation of the Act
Problematic consultation process
Composition and work of MTT
Rushed passage of three key bills
Failure to consider comments made on draft Bill

10. Parliamentary amendments
Portfolio Committee version
Removed two-tier system
Improvements to office of the CEO
Certain – but not all – proposed disqualifications from office introduced
Express grounds for dismissal of CEO
Addressing conflicts of interest
Human resource policy to deal with conflicts of interests
Appeal committee members’ financial/business interests in affairs of parties
Removal of restrictions regarding relief in reviews
Implicit requirement that time lines be set out in regulations
Select Committee amendments
Expanded Authority powers re: Act’s implementation and application
Introduction of provisions dealing with corporate governance
Authority to “act impartially without favour or prejudice”

11. Way forward NCOP plenary Back to the Portfolio Committee in the NA
Mere formality (as a section 75 bill)
But timing may be a problem
Back to the Portfolio Committee in the NA
Amendments may be accepted or rejected, or Bill abandoned
Timing definitely an issue
Presidential assent
If no constitutional concerns, must assent to and sign the Bill
Once signed, Bill becomes an Act and subject to challenge
Regulation drafting process
Should provide some of missing detail
New Minister likely to ensure a proper consultation process

12. 6th floor, Braamfontein Centre,
23 Jorissen Street,
Braamfontein,
Johannesburg,
SOUTH AFRICA
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