Medical Schemes Amd Bill: finalisation; Medicines & Related Substances Control Amd Bill: deliberations

Meeting report

SOCIAL SERVICES SELECT COMMITTEE
6 November 2002
MEDICAL SCHEMES AMENDMENT BILL; FINALISATION; MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT BILL: DELIBERATIONS

Chairperson: Ms L Jacobus (ANC)

Documents handed out:
Medicines and Related Substances Amendment Bill [B40B- 2002]
Occupational Diseases in Mines and Works Amendment Bill [B39B-2002]
Medicines Schemes Amendment Bill [B37B-2002]

MINUTES
[This meeting was not minuted by PMG; it is an extract from a report by parliamentary staff]

Medical Schemes Amendment Bill
The Bill was accepted by the Committee with amendments.

Medicines and Related Substances Amendment Bill
The Committee deliberated on the Bill.
This Bill enables the Department of Health (the Department) to rectify a few legal drafting errors that occurred in the Medicines and Related Substances Act of 1997 (the principal Act), such as the rectification of references to Section 3 of Act 101 of 1965. The Bill also brings government in line with international obligations regarding more stringent controls in the importation and exportation of drugs. Search and seizure activities with regard to private homes now require the obtaining of a warrant rather than the random searches done previously.

Clause 1
This clause defines the term Magistrate in keeping with Act 90 of 93 and retains the definition of 'medical devices'. It was felt that the Medical Control Council (MCC) should still retain control over these devices even though the forthcoming National Health Bill will contain a section on medical devices. The Department originally opted for a differentiated approach to medicines and medical devices. With the amendment, a small group of devices, such as medicated devices, will continue to fall under the jurisdiction of Medicines and Related Substances Act. The MCC currently registers these devices as a medicine. Some exemptions are possible, as provided for in Section 36 of Act 101 of 1965.

Clause 2
This clause rectifies the cross referencing errors that occurred in drafting.

Clause 3
This clause seeks to assist in areas such as the appointment of one or more Deputy Registrars to alleviate some of the workload burdens experienced by the current Registrar. This is in line with other legislation.

There would initially be cost implications here, but this is tied into the annual budget allocation to the MCC by the Department. However, the income generated by the MCC on an annual bases is approximately R5m.

Clause 4
This clause provides for the inclusion of an enforceable set of regulations regarding a Code of Practice, which would then govern the marketing of medicines. The pharmaceutical industry as a whole as well as all stakeholders are thus expected to adhere to the provisions and the subsequent regulations.

Clause 5
This clause allows the Department to fulfil its international obligations with regard to the control of medicines, including those contained in Schedules 5, 6, 7, and 8. Some of these drugs are involved in very lucrative international markets and, without the necessary control mechanisms in place, South Africa would be unable to curb contraband drugs such as narcotics from illegally entering our country. Strong control measures are therefore necessary within the industry to differentiate from that which is supposed to circulate within the confines of affiliated and accredited organizations charged with the responsibility of dispensing medicines and those who import or export unsafe, illegal drugs onto black markets.

Clause 6
This clause allows for the MCC to issue export and import licenses for those manufacturers who wish to compound and dispense drugs. More importantly, it allows for those manufacturers who wish to dispense drugs to undergo a training course. This first has to be approved by the South African Pharmacy Council after consultation with the Health Professions Council of South Africa, the Allied Health Professions Council of South Africa and the South African Nursing Council. Accredited institutions of higher learning will offer these courses, and only after the successful completion of these courses will applicants be issued with a license to dispense or manufacture medicines.

Clause 7
This clause ensures that the conditions for the licensing of dispensing doctors and any other accredited dispensing agency or individual will include the provision of required information to patients, informing them about the type of the generic equivalent in use. In the past the Department information indicated that many dispensing doctors preferred branded drugs instead of generics because of the financial kickbacks they receive. These doctors either deliberately or otherwise failed to mention that there was a cheaper, equally effective, generic substitute available. This provision mandates doctors to inform patients of the generic version.

Clause 7
Other areas that this Bill seeks to rectify are the provision of clear guidelines with regard to the term of office of members of the Pricing Committee. This clause also brings on board those wholesalers or distributors or people selling Schedule O medicines. These categories of people have in the past been prevented from influencing the pricing of drugs, and this had a negative impact on drugs prices. It was felt that by bringing them on board in this manner, the prices of drugs could be better regulated and controlled.

There were still some questions as to the upper limit on the prices of drugs. There is currently no mechanism in place which will help to curb the unnecessary spiralling costs of drugs. There is no measure in place to monitor or control drug prices between manufacturers and wholesalers, and there is also a lack of transparency. The industry manipulates internally. When this Bill is implemented it is envisaged that there will be greater interaction between the industry's pricing mechanisms and the pricing committee. The Pricing committee will be empowered to make recommendations to the Minister, especially if prices in South Africa are found to be disproportionately high vis-à-vis prices elsewhere on the continent or internationally.

The Department sees the need for the Pricing committee to have a clear indication of the actual prices of medicines. If prices are too high the option of parallel impartation needs to be explored, as well as the option of approaching international markets to reduce the price of drugs.

Clause 9
This clause speaks to the appeals process and provides that there are two types of appeals, namely one against the decision of the MCC and one against the decisions of the Director-General of the Department. Should anyone have a concern with a decision made by the Director-General (the DG) via this amendment, that person has the power to appeal to the Minister of Health (the Minister).

An Appeal Committee has the power to overturn the decision of the MCC. This amendment also provides that it is now no longer a requirement that the chairperson of such an appeals committee have ten years experience. The Chairperson is now only required to have the necessary knowledge of the law.

The Minister appoints the appeals committee, and their responsibilities are primarily centred on quality, efficiency and safety of medicines. Expertise in the various areas of chemistry etc. are therefore prerequisites.

The legal office of the Department has advised that the current use of legal experts has changed the manner in which judges are appointed, and the Department has taken the cue from this process regarding the way in which the Chairperson of the appeal committee is now constituted.

Clause 10
In the course of conducting its business the MCC may have to defend its decisions in court or elsewhere. This clause ensures that all the members of the council and its relevant committees are protected from being sued if their decisions are challenged, especially when these decisions were made in good faith. The individuals serving on these committees, such as the Pricing Committee etc., will therefore not be held liable for their decisions.

Clause 11
The provisions in the principle Act for inspectors to at any time enter premises where alleged illegal practices were conducted was deemed unconstitutional, leaving no legislative framework for inspectors to conduct their work. The provisions of this clause now ensures that inspectors who enter premises for the purposes of search, seizure and collection of samples are able to operate within the framework of the Constitution.

In the cases of private dwellings, inspectors are now required to obtain a search warrant before entering those premises, if there is a reasonable ground to believe that a crime is being committed.

Those premises governed by the regulations of the MCC are currently subject to routine inspections.

Clause 12
This clause enables the drafting of regulations which will govern the process of exportation of medicines.

Clause 13
This clause contains the long title of the Bill.

Clause 14
This clause deals with the repeal of the South African Medicines and Medical Devices Regulatory Authority Act 132 of 1998

Clause 15
This clause contains the short title of the Bill.

There were no further questions or comments and the meeting was adjourned.