Without much fanfare the National Assembly’s portfolio committee on health recently made a decisive break with its past. In adopting the Medicines and Related Substances Amendment Bill [B 44B–2008] on September 3 the committee substantially rewrote a deeply flawed and highly controversial piece of draft legislation tabled by the former minister of health, Manto Tshabalala-Msimang, in Parliament earlier this year. Until then the committee — in its current form — had effectively served as a rubber stamp for the executive’s proposals on law reform. To be fair, few committees in Parliament had acted any differently in the pre-Polokwane era.
When originally tabled in June, the former minister’s Bill elicited strong responses. In predicting that it would “undermine the scientific governance of medicine”, the Treatment Action Campaign (TAC) argued that “[t]here already is severe political interference with the scientific governance of medicine, — but this Bill aims to give the [former] minister’s meddling legislative force”. Of much concern to the TAC was the Bill’s proposal to “give the minister of health the power to block the registration of medicines of proven quality, safety and efficacy, as well as to allow the sale and provision of untested ‘treatments’ and ‘cures'”. Others were similarly condemnatory.
Most of the sting in the former minister’s Bill has been removed. The “two-tier” registration system — which would have empowered the minister to block the registration of medicines on the basis of somewhat vague and uncertain criteria — has gone. So too has the minister’s effective veto role in the authorisation of unregistered medicines, which is governed by section 21 of the Act. Among other elements, that provision allows for the use of unregistered medicines that have been approved for use elsewhere, the compassionate use of experimental drugs that have yet to be approved anywhere and the use of promising new products in clinical trials.
In response to concerns about the need for the proposed South African Health Products Regulatory Authority to be independent and shielded from political and commercial interference, the portfolio committee took a number of important steps. It agreed to provide more detail about the authority’s chief executive. Importantly, certain disqualifications from office — dealing with criminal records, insolvency and mental health status — were introduced. (But proposals regarding political office and financial interests in the “pharmaceutical, medical device and/or other health product industry” were not taken on board.)
The committee also introduced an important provision to protect the chief executive from political interference: he or she may be dismissed only for “serious misconduct”, “permanent incapacity” or “engaging in any activity that is reasonably capable of undermining the integrity of the authority”. Further, concerns about financial interests should be somewhat — although not completely — addressed by the human resource policy that the revised Bill requires the minister to develop. This should “include a code of conduct and provisions on conflict of interests applicable to the chief executive officer and the staff of the authority”.
There are further provisions in the revised Bill that are also to be welcomed, such as the express recognition that members of appeal committees are to have no financial or business interests in the affairs of the parties to any appeal, the removal of restrictions regarding the relief that may be granted by the high court in review applications, an implicit requirement that timelines for the consideration of applications by the authority be set out in regulations, finely tailored provisions dealing with medical devices and an expansion of regulatory oversight to cover all foodstuffs and cosmetics that contain scheduled substances.
The amended Bill — passed by the National Assembly in late September and considered by the select committee on social services in the National Council of Provinces (NCOP) this week — still falls short of properly ensuring that the authority is able to function as an independent and accountable government agency.
To be fair, the committee has accepted a number of additional progressive amendments. Among others, these include an expansion of the authority’s powers relating to the law’s implementation and application, the introduction of certain provisions dealing with corporate governance and a requirement that the authority “act impartially without favour or prejudice” when performing its functions.
All of these amendments go some way towards giving meaningful effect to the recommendations of the ministerial task team on the restructuring of the medicines regulatory affairs and medicines control council, which, in essence, called for the establishment of an independent regulatory authority. But even in its latest form, which has yet to be adopted by the NCOP, the Bill does not go far enough. To guarantee the authority operates independently and accountably, as the Constitution requires, the Bill still needs to provide greater detail about its structure and nature, deal appropriately with the chief executive’s appointment and provide Parliament with a much stronger oversight role.
Equally important is the need to address concerns about the minister’s power to exclude medicines and other health products from the operation of all or part of the Act. Right now, this power can be exercised only on the unanimous recommendation of an independent statutory council. The Bill would have the authority to make that recommendation instead. For as long as the new body’s independence is not guaranteed, regardless of who occupies the office of minister of health, concerns will remain that the power to exclude could be used inappropriately to advance a political or commercial — instead of a public — interest.
Jonathan Berger is a senior researcher at the Aids Law Project. He is on sabbatical leave as a visiting researcher at the Georgetown University Law Center in Washington, DC