The South African Medicines and Medical Devices Regulatory Authority Bill makes provision for the establishment of an autonomous, independent and impartial body: The South African Medicines and Medical Devices Regulatory Authority Bill will replace the Medicines and Related Substances Act, 1965 and amend the Fertilizers, Farm Feeds, Agricultural Remedies Act, 1947.

The medicines regulatory system that currently exists in the country was established by law in 1965, and does not adequately serve the interest of public health in the contemporary South African context. The need for new legislation has been identified because of weaknesses in the present system. These weaknesses relate to ineffective communication, inadequate administrative systems, confusion about the division between policy and technical matters, and the inability of the current system to respond appropriately to the needs of the country.

Under present legislation there is no provision for dealing with complementary- and traditional medicine. This bill will, in the interest of public safety, extend the regulation and control of medicines to include orthodox medicines, as well as complementary / non- orthodox / traditional medicines, veterinary medicines and medical devices.  

2. Main Provisions of the Bill

The proposed bill provides for the:

• establishment of the South African Medicines and Medical Devices Regulatory Authority (SAMMDRA);

• regulation and registration of medicines intended for human and for animal use;

• control of orthodox medicines, complementary medicines, veterinary medicines, scheduled substances and medical devices;

• control of persons who may compound and dispense orthodox medicines, complementary medicines and veterinary medicines; as well as for the

• repeal of the Medicines and Related Substances Control Act, 1965; and the

• amendment of the Fertilizers, Farm Feeds, Agricultural Remedies Act, 1947.

3. The Purpose and Functions of the SA Medicines and Medical Devices Regulatory Authority

The primary purpose of the Authority is to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, veterinary medicines, clinical trials and medical devices.

In order to fulfil these functions the Authority must:

• ensure the efficient, effective and ethical evaluation and registration of medicines and medical devices to meet defined standards of quality, safety and efficacy;

• ensure that best practices are adopted so that the process of evaluating and registering medicines and medical devices are transparent, fair, objective and concluded timeously;

• ensure the periodic re-assessment and monitoring of medicines and medical devices;

• monitor, analyse and act on evidence of existing and potential adverse indications with regard to pharmaceutical products;

• ensure the promotion of compliance with existing legislation through a process of active inspection and investigation; and

• ensure that clinical trial protocols are assessed according to prescribed ethical and professional criteria and defined standards.

The Authority has the right to appoint agents to execute duties in relation to the monitoring, evaluation, investigation, inspection, registration and control of medicines and medical devices, on its behalf.

4. Essential Elements of the Bill

• A revision of the definition of a medicine, as well as appropriate definitions for complementary- and traditional products. In this regard, "orthodox medicine" is defined as "any substance or mixture of substances...other than a complementary medicine or any other product intended to be used.....for use for its therapeutic efficacy or pharmacological purpose". "Complementary medicine" is defined as "any substance or mixture of substances, originating from a plant, mineral or animal...used..., manufactured or sold for use in complementing the healing power of a human or animal body." This includes substances generally referred to as Western herbal medicine, African traditional medicine, traditional Chinese medicine, traditional Dutch medicine, homeopathic, ayurvedic, aromatherapeutic medicines and food supplementation.

• Revised criteria for licencing and registration of medicines and medical devices, as well as measures to control the marketing of medicines.

• The establishment of an Inspectorate.

• The establishment of appropriate procedures for appeal.

• Avoidance of conflict of interest. There are specific rules stipulating disclosure of conflict of interests of members and/or the agents of the Board. Any person with a direct or indirect vested interest in a product or company under consideration is not allowed to be part of the proceedings.

The bill proposes that the Authority should be managed by the Board, appointed by the Minister. The Board will be comprised of a chairperson, a vice-chairperson, a person representing the Minister of Agriculture, a person representing the Minister, and no fewer than five but no more than eleven persons as determined by the Minister.

The Chief Executive Officer and chairpersons of standing committees appointed by the Authority, are ex officio, non-voting members of the Board. The Minister determines whether a person on the Board serves in a full-time or part-time capacity. The Board, in consultation with the Minister, appoints an executive committee from among its members, which consists of the chairperson, the vice-chairperson, a maximum of three other members, one of whom must be representing the Minister of Agriculture.

Members of the Board are appointed for a maximum period of five years, but may be re-appointed for another term. Vacancies on the Board, before the term of office has expired, will be filled by persons appointed by the Minister for the duration of the specific term of office only.

According to the Bill, members of the Board must be "appropriately qualified, fit and proper persons" committed to the principles of "fairness, openness and accountability". The Bill acknowledges the need for affirmative action and states that collectively the Board should represent a "broad cross-section of the population of the Republic".

The Board, in consultation with the Minister, must appoint standing committees and / or experts for, but not limited to:

• orthodox medicine
• complementary medicine
• veterinary medicine
• medical devices, in order to assist the Board in the effective performance of its functions.

The Chief Executive Officer must appoint a secretariat to provide administrative support to the committees of the Authority. Renumeration and allowances for committee members/ experts are determined by the Board.

The Minister has to issue policy consistent with the goals and objectives of the Authority. To this extent the Minister must consult the Authority, and promote broad civil society consultation before policy is issued.

6. Finances

Financial accountability is vested in the Board. Operating and capital costs will be financed by a grant from government.

Additional finances for the Authority may be obtained from:

• own revenue from fees charged for services rendered
• donations/ contributions from persons not associated with the medical industry, and/or
• loans

7. Registration

The bill stipulates detailed guidelines for the registration of medicines, veterinary medicines and medical devices. The process is fairly reasonable and transparent.

8. Inspectorate

The bill calls for the establishment of an Inspectorate to ensure quality control and compliance with the standards set by the law. This unit should be autonomous, and must operate free from political and commercial influence.

9. Enforcement

Medicines and medical devices that are not registered may not be manufactured, packaged, distributed, marketed or sold. Non-compliance is punishable with a fine, or a prison sentence of maximum ten years, or both.

10. Appeal

The bill makes provision for the appointment of an independent and impartial Appeal Board by the Minister. The Minister determines the rules and procedures to be followed by the Appeal Board. The Appeal Board hears and decides on all appeals by persons aggrieved by decisions of the Authority.

• The bill allows for greater public participation, and the involvement of groups and individuals who had been excluded from participation in the previous system. Currently, the present system there are no systematic strategies for the inclusion and capacity building of groups and individuals from marginalised groups. Often the same groups act as advisors / consultants to the present regulatory authority. They thus acquire considerable skill and expertise in this area and become indispensable to the authority. In addition, these groups have considerable power and influence. The bill acknowledges the need for affirmative action so that groups and individuals who had been excluded from participation in the current system will be given the opportunity to gain knowledge and experience in this highly specialized field. However, the process for the implementation of affirmative action strategies is not clear.

• Extensive discretionary powers are granted to the Minister with regard to the appointment of members. The bill does not guarantee broad public participation and involvement in the nomination and selection of members of the Authority.

• Specialist / professional skills in the medical field are not requirements for appointment to the Authority. This may allow for greater balance and cross -sectoral discussion and debate, thus expanding the areas of consideration in favour of public interest.

• The process of reform can be slow, because of limited administrative capacity and inadequate resources to implement the new system. This may result in delays with regard to the registration of medicines, especially as large numbers of non-orthodox medicines have to be registered. Administrative problems may frustrate stakeholders and/or delay treatment.

• Strict measures are necessary in the interest of public safety, but the proposed regulations with regard to registration, and the payment of a fee for registration may increase the cost of medicine.

• The definitions of "orthodox medicines", "medical devices" and "complementary medicines" should be revised to avoid confusion.

• The bill does not respond to the need for public education with regard to the rational and responsible use of drugs. South Africa needs an effective drug information and education system and it should be the responsibility of the Authority to develop and implement such a system.

PHILA

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