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

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

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

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 (2009-2014) Greater oversight of the exercise of national executive authority Major amendments to tabled bills Ousting of President Mbeki leads to mini Cabinet reshuffle

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

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

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

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

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

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”

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

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