Proposal to Change Medicine Dispensing System

1. Background

In a Government Gazette dated 12 July 1996, the Department of Health announced plans to restructure the dispensing system and labelling of medicines. The Department has motivated for these regulations based on site visits to dispensing private practitioners' offices where they found the conditions to be unhygienic and unsafe. Although this policy appears to address the issue of public safety, there are many questions about its relationship to other Departmental initiatives and the implications of the proposal for underserved communities that remain unanswered.

2. The Proposal

A series of proposed regulations to the Medicines and Related Substances Control Act, 1965 were published by the Department of Health. Many of the regulations relate to the labelling and information packets included with medicines. These are designed to provide more clear information to patients about their medicines.

The most controversial aspect of the proposed regulation suggests that Section 52A of the Medical, Dental and Supplementary Health Service Professions Act, 1974 will be amended or repealed. This provision grants practitioners the right to dispense medicines. Thus, medical practitioners will lose their ability to dispense medicines.

The provisions of this Act will be replaced by this regulation which states that, "No medical practitioner and dentist shall dispense or sell a medicine or scheduled substance on prescription to any patient under care except when, on application, has been authorised thereto by the Director-General and provided her or she has successfully completed a supplementary course in dispensing practices prescribed for this purpose by the South African Medical and Dental Council in consultation with the South African Pharmacy Council who shall determine the standards of dispensing, and is certified competent to dispense medicines." Medical practitioners are permitted, however, to use medicines on a non-recurring basis that are necessary only for emergency treatment of patients.

Reading the regulation, it appears as if medical practitioners and dentists will have to apply to the Director-General for permission and complete an additional course to dispense medicines. If there application is approved, they will have to submit the proper forms certifying their status and registration with the relevant statutory council to the Registrar of Medicines who will issue a license.

Dispensing licenses will be renewed annually. The license can be withdrawn if practitioners ceases to comply with the conditions of the license. It is not clear from the regulation as drafted whether the Director-General, the Registrar of Medicines, or someone else will make determination whether practitioners are complying with the conditions listed below. The monitoring and evaluation process is not specified.

The criteria for dispensing relate primarily to having the proper equipment and a hygienic environment to safely dispense medicines. The criteria include:

• Proper preparation surface;
• Appropriate temperature controls;
• An adequate area to wash equipment;
• An adequate functioning ablution area;
• Proper equipment to measure;
• Adequate lighting and ventilation;
• Sufficient shelving;
• Restricted public access;
• Being neat, clean, and tidy;
• Sufficient space; and
• A working refrigerator.

3. Some Questions of Clarity about the Proposal

There are two fundamental legal questions that need to be addressed before the content of the regulation is even considered. First, can a Departmental regulation supersede an Act of Parliament? If not, then this regulation is premature and cannot take effect until the Medical Act of 1974 is amended or repealed by Parliament. Second, can a Department take over powers from an independent body created by Parliament by means of regulation? If not, then the basic change proposed in moving control of dispensing medicines from the Interim Council to the Director-General is unconstitutional.

The regulation does not clearly state why medical practitioners and dentists have to be confirmed by the Director-General (DG) while practitioners, veternarians and authorised nurses need only to submit their approved licenses to the Registrar of Medicines for confirmation to dispense. It is not clear whether this is an typographical error or whether it is intentional that nurses and others will not have to be certified by the DG to dispense medicines. If the latter explanation is true, what is the Department's motivation for this policy?

Once the National Health System is fully implemented, it is envisaged that essential medicines will be dispensed from public clinics and district hospitals. Does the proposed regulation apply only to private practitioners? Will public clinics undergo the same training and scrutiny? Will public clinics lose their license to dispense medicines if they do not meet these conditions? As the majority of patients seek treatment at public clinics, it is more important to maintain safe dispensing conditions at these facilities.

In the list of criteria, there do not seem to be any which determine whether there is a pharmacy in the area. Thus, it is not clear how this policy relates to earlier proposals to rationalise dispensing of medicines by private doctors working in areas where pharmacies exists. Are these two policies related to one another?

No provisions seems to have been made in the case where medical practitioners working in remote areas are not licensed to dispense. Where will people in these communities receive their medicines? Have contingency arrangements been made to ensure that people do not lose access to medicines?

The official policy on essential drugs list announced by the Department of Health in January 1996 stated that Essential drug list (EDL) medicines will be available at all district hospitals, public providers, and accredited private providers. How does this regulation relate to the larger EDL policy of the Department? What is the Department's motivation for addressing the dispensing of medicines through separate regulations rather than through comprehensive legislation?

4. Some Issues Raised in the Debate

The proposed regulation has created an outcry from private medical practitioners that has been well covered in the media. Some of the major issues highlighted by private doctors and other analysts are listed below. As with the proposal for additional vocational training for medical practitioners, there has been little public comment from consumers and communities on this issue.

• Have communities been consulted about these changes? Is there ownership of the plan?

It does not appear the impact of this regulation on underserved communities has been considered. It is not clear what consultation practice took place around this issue. This proposed change is not an academic one. It will fundamentally impact on accessibility of medicines for the population.

Most of the discussion after the proposed regulations were published has been dominated by doctors and the Department. Little thought seems to have been given to the impact of the proposal on disadvantaged communities. There is a danger in the short-term that people in disadvantaged communities will lose accessibility to services. What will happen in rural areas and townships where there are no pharmacies? It seems the practice of getting medicines directly from private doctors is preferable for many poor people. An impact analysis of the proposal on poor communities should be done before this policy is implemented.

• One important issue that has not been covered is how this proposal will impact the availability of medicines in rural and peri-urban areas. There are several important questions from the community's perspective that the Department must address before this policy is implemented.

• Will medicines be more affordable if this policy is implemented?

One of the underlying principles of the new National Health System is that the financial barriers to access to PHC services and the quality of services delivered should be equivalent for all users of the system. Many of the people who take advantage of the private dispensing system are poor, but are using the private sector because of the poor quality and inaccessibility of the public system currently. In the long-term, it is envisaged that many of these people will return to public system. Will the new licensing policy on dispensing make medicines more or less affordable for these individuals in the short-term?

• Will medicines be more accessible to communities if this policy is implemented?

Another principle of the new NHS is universal access to primary health care services. It is convenient for some people now to receive medicines from their private doctor during their consultation visit. How will this relationship be impacted by the new regulation? There should be good cause to reduce the accessibility of health services for certain people at the same time that the Department aims to improve accessibility within the system.

• Will the dispensing of medicine be safer under this proposal?

The Department has emphasised this point as a motivation for the new licensing system. They site examples of unhygienic practices occurring in the offices of dispensing doctors. It is not clear from the evidence presented how widespread and dangerous the abuses are currently. Do these problems warrant the proposed solution? It is clear that some of the most flagrant abuses will be corrected to obtain licensure, but there are no guarantees that safer practices will be maintained over time. Will the regulation put into place an efficient monitoring and control system to ensure the safety of the public over time?

• How does this proposal relate to the dispensing of medicines by other cadres of health workers?

The Department of Health has formally endorsed a policy to expand the privilege of dispensing certain medicines to nurses in the public sector. It is not clear how these two proposals are related. Given the current shortage of staff and equipment in many public clinics where nurses will be dispensing medicines, many clinics will not be properly equipped to meet the stringent criteria in the short-term. Will they be upgraded to meet the required criteria? In the absence of concrete plans to upgrade standards in public clinics, it is not clear how these regulations will make the dispensing of medicines safer for the majority of people.

5. Consultation Process/Way Forward

Normally, there is a period for public comment on all proposed regulations printed in the Government Gazette. These proposed regulations were published on 12 July 1996. According to the notice, 45 days were given for public comment on these regulations before they took effect. The regulations are scheduled to take effect three months after the publishing the regulation on 12 October 1996. Due to the controversy surrounding the regulations, the deadline for comments has been extended until September.

The National Assembly Portfolio Committee on Health will conduct a public hearing on this issue on Monday 16 September 1996. NPPHCN has been asked to make a written and oral submission to the Committee. Although the Committee does not have direct authority to amend or overrule Departmental regulations, they will be reviewing the proposed regulations and making recommendations in a formal Committee Report to the Department of Health and other stakeholders. In order to take effect, these regulations require that an Act of Parliament must be amended or repealed. Although, the amendments have not been formally introduced, the Health Portfolio Committee must consider them at some point in the future. Thus, it is important to make submissions both to the Department of Health and the Health Portfolio Committee.

Last updated: 14/12/98
Please send comments or suggestions about this site.