A Written Submission
by
The National Progressive Primary Health Care Network
on
Proposed Regulations to Change the Medicine Dispensing System
Submitted to
The National Assembly Portfolio Committee on Health
on
16 September 1996

1. Introduction and Background

In a recent Government Gazette dated 12 July 1996, the Department of Health announced a series of regulations to change the labelling and information packets of medicines and to restructure the dispensing system for medicines by private doctors. The Department has motivated for these regulations based on site visits to numerous dispensing private practitioner's offices where they found the conditions to be unsafe and unhygienic. In a press release, the Department stated that most private doctors are dispensing in unsafe conditions. This regulation forms one part of the Department's National Drug Policy released earlier this year.

The National Progressive Primary Health Care Network (NPPHCN) is a national non-government organisation founded in 1987 to advocate for the implementation of a national health system for South Africa based on the principles of the Primary Health Care (PHC) approach. NPPHCN has a membership of more than 1,100 health and development programmes, projects, and individuals. We have offices in eight of the nine provinces and our national office is based in Johannesburg.

2. The Constitutional Context

Chapter two of the New Constitution contains the Bill of Rights, the most fundamental rights of citizens by which all levels of government and other individuals in some cases are bound. The "Bill of Rights is the cornerstone of democracy in South Africa. It enshrines the rights of all people in our country and affirms the democratic values of human dignity; equality and freedom. The state must respect, protect, promote, and fulfil the rights in the Bill of Rights."

Specific health care rights also have been included in the Constitution. "Every person has the right to have access to:

• (a) health care services, including reproductive health care;

  (b) sufficient food and clean water; and

  (c) a social security system including, if they are unable to support themselves and their dependants, appropriate social assistance."
  

Further, "the state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of each of these rights." This places the burden on the government to take measures to provide health care services, food, water, and social security to all South Africans. Finally, no one may be refused emergency medical treatment. The Constitution must be the benchmark against which all health policies, regulations, and legislation are measured.

3. NPPHCN's Positions

Historically, many doctors in organisations such as NAMDA, SAMDP, SASSHO, and the Health Workers Society dispensed medicines to meet the urgent needs of poor communities caused by the inadequacies of the previous health system. NPPHCN would like to the thank these doctors for their tireless efforts during the struggle. Notwithstanding their service during the apartheid era and arguments to maintain their freedom of economic activity, the Constitution does not provide doctors with the "right to dispense medicines." NPPHCN firmly believes that the most important consideration in this debate should be the rights of all communities to receive accessible, affordable, and safe health care services, including medicines.

• The current dispensing system for medicines needs to be rationalised.

Medicines in South Africa are currently too expensive. Huge profiteering is occurring throughout the medicine manufacturing and distribution chain. There is a unacceptably high level of fraud and abuse in this system at many levels. From this evidence, it is clear that the current medicine manufacturing and distribution system has broken down and needs major reform urgently. Thus, NPPHCN restates its endorsement of the Department of Health's National Drug Policy released in January 1996.

For example, there is an uneven and irrational distribution of facilities that dispense medicines. It many areas like Sandton and Sea Point, there are numerous pharmacies and dispensing doctors for patients to choose from while in areas like Soweto and Khayelitsha there are few or no choices. Given this situation, it concerns NPPHCN that the availability of pharmacies in an area was not explicitly included in the list of criteria used to decide if a license should be given to dispense medicines. Although the Department has mentioned this issue in its public statements, we think that this criteria should be added to the regulation. The Department should develop clear national policy guidelines on this issue, but specific decisions about which facilities and practitioners can dispense in a particular community should be taken at the district level.

• Communities should be consulted about these changes.

Based on the debate that has occurred in the media between private doctors and the Department of Health, the impact of these regulations on underserved communities seems to have been ignored. It is not clear what consultation with communities has taken place on this issue. The Department must ensure that the estimated 3-5 million people who receive medicines from dispensing doctors each month are properly consulted about these changes.

• Patients must be given more information to allow them to make informed decisions about medicines.

Doctors currently hold the upper hand in their relationship with patients. As a result, patients often accept the diagnosis, treatment, and medicines recommended by doctors without question. It is potentially inefficient, more expensive for the system, and disempowering for the patient for a single person to control all of these decisions. Internationally, dispensing doctors have been shown to write more scripts than their non-dispensing counterparts. They are also more likely to dispense the medicines in their possession which may or not be the most effect treatments.

NPPHCN supports the new labelling and information regulations proposed by the Department as an effort to provide patients with more clear information to allow them to compare medicines. In addition, NPPHCN supports the separation of the diagnosing and dispensing functions although we are not clear that these regulations achieve that goal.

• Medicines must be more and not less affordable after these regulations are implemented.

One underlying principle of the new National Health System is that financial barriers to access to PHC services and the quality of care should be equivalent for all users of the system. Many people who take advantage of the private dispensing system are poor, but they are using the private sector because of the poor quality and inaccessibility of the public system. In the long-term, it is envisaged that many of these people will return to the public sector.

NPPHCN supports the introduction of the Essential Drug List (EDL) and the change to a flat dispensing fee that will make medicines more affordable to the public over time. It is not clear, however, what provisions in the current regulations will make medicines more affordable to the public. People who are currently being diagnosed and receiving medicines for a single fee will now have to pay two separate fees plus the additional cost of time and transport. There is no guarantee that the medicine required will be available at the nearest pharmacist. Considering this information, NPPHCN recommends that this regulation be incorporated into comprehensive legislation addressing the affordability of medicine so that some poor people do not suffer until the National Drug Policy is fully implemented.

• Medicines must remain accessible to communities if these regulations are implemented.

Another principle of the National Health System is universal access to PHC services. Currently, it is much more accessible for some people to receive medicines from their private doctor during their consultation. This accessibility should be acknowledged until the public sector is able to provide a comparable level of service.

NPPHCN is particularly concerned that the regulations, as currently drafted, may leave some communities without access to medicines in the short-term. In communities without access to pharmacies or dispensing public clinics, alternative arrangements must be made to ensure that people do not lose their access to medicines. One option could be to grant provisional licenses to doctors in these areas until they are able to meet all of the licensing requirements. Additional monitoring would be necessary to protect the safety of the community. Again, the Department has discussed this issue publicly, but it has not been included in their written regulations.

• The dispensing of medicines must be safer under the new regulations.

The Department has emphasized safety as a motivation for implementing the new licensing system. They cite examples of unsafe practices occurring regularly in doctor's offices. Based on this anecdotal evidence, it appears that abuses are occurring by some dispensing doctors. The safety regulation and monitoring of the private dispensing system clearly needs to be improved. NPPHCN supports the additional hygiene and safety criteria proposed.

Once the National Health System is fully implemented, it is envisaged that essential medicines will be dispensed from public clinics, district hospitals, and accredited private providers. NPPHCN believes that the proposed regulations must apply to both public and private sector health workers at all level facilities. Corrective actions should be taken immediately to improve the condition of public sector facilities that do not meet the basic criteria listed in the regulations.

4. Concerns about the Legality of the Regulations

After seeking expert legal opinion, NPPHCN is concerned about the legality of this regulation. It is not clear that a Departmental regulation can supersede an Act of Parliament. Thus we do not believe that this regulation can take effect until the Medical, Dental, and Supplementary Health Service Professions Act of 1974 has been amended or repealed by Parliament.

In general, NPPHCN is concerned by the wide discrepancies that exist between the Department of Health's public statements and policy documents and the written content of its regulations. Questions about the capacity of its legal unit were raised by the Public Protector's Report on Sarafina 2. The poor quality of the drafting of this regulation and the basic legal questions surrounding its validity suggest that this issue has not been addressed. NPPHCN encourages the Department to upgrade it legal capacity so that its progressive policies will not be sidetracked on technical grounds in the future.

5. Recommendations to the Department of Health

Although NPPHCN supports the National Drug Policy and the EDL as comprehensive measures to address an urgent problem, the regulations proposed here raise more issues than they address. Thus, we recommend that they be incorporated into comprehensive legislation to implement the entire National Drug Policy. This legislation should address:

• The profit motive in the medicines industry,
• The separation of diagnosis from dispensing,
• The PHC team approach rather than individual professions fighting for territory, and
• The accessibility, affordability, and safety of medicines in poor communities

Last updated: 02/02/00
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