Date added: 09 June 1997

Pharmacy Amendment Bill, 1997

1. Introduction

The Pharmacy Amendment Bill, 28 of 1997, was introduced to Parliament by the Minister of Health in May 1997. The Bill makes amendments to the Pharmacy Act, 53 of 1974, in order to bring this Act in line with the government's National Drug Policy (NDP), which was released in February 1996.

In summary, the Bill provides for the establishment of a permanent Pharmacy Council and deals with issues relating to the practice and rendering of pharmaceutical services in South Africa. It outlines the composition, general powers and objects of the Council, and extends the control of the Pharmacy Council to the public sector.

2. The Need to Transform the Pharmacy Act

The NDP needs to be seen in the broader context of the restructuring of the health system in South Africa. The legacy of apartheid was a fragmented health service characterised by gross inequities in service provision and access to health care. The White Paper on the Transformation of the Health System in South Africa, released in April 1997, lays the framework for a comprehensive and integrated health system and has as its main objective the provision of primary health care services to all South Africans. The NDP looks particularly at improving the pharmaceutical sector. The aim of the NDP is to "ensure an adequate and reliable supply of safe, cost-effective drugs which are of acceptable quality, to improve access to medicines for all South Africans, and to improve the rendering of pharmaceutical services".

The NDP was a result of wide consultation with key roleplayers, including representatives of provincial health departments, the pharmaceutical industry, professional organizations and statutory bodies. Part of this policy is already being implemented. The Department of Health has published a list of essential drugs and standard treatment guidelines. Further, the South African Drug Action Programme (SADAP) has been set up within the Department of Health to oversee the implementation of the NDP in the public and private sector. This programme is particularly entrusted to support provincial activities and strategies to improve pharmaceutical services. Other aspects of the policy can only be implemented through changes in current legislation. Thus, the Minister of Health has proposed amendments to three Acts - the Medical, Dental and Supplementary Health Professions Act, the Medicines and Related Substances Control Act, and the Pharmacy Act.

The Pharmacy Council, in conjunction with the Minister of Health is responsible for administering the Pharmacy Act. The Act deals with maintaining acceptable standards in the provision of pharmaceutical services, and concerns the practices of the pharmaceutical profession in particular. Thus, the Pharmacy Act relates directly to the NDP and needed to be amended to bring it in line with the government's policy.

3. The Process to Transform the Pharmacy Act

The Interim Pharmacy Council of South African (IPCSA) was established in 1995, by legislation. The legislation dissolved the Pharmacy Council, and similar councils which existed in the former homelands. The IPCSA’s mandate was to review existing legislation and create a new legal environment for a more representative Council, in alignment with the new constitutional context and the objectives of the national health policy. Its terms of reference were to make recommendations which support universal norms of the pharmaceutical profession, and which place greater emphasis on "professional practice, democracy, transparency, equity, accessibility, and community involvement". The IPCSA made recommendations to the Minister at the end of 1996.

4. Summary of the Contents of the Pharmacy Amendment Bill

The proposed legislation affects all roleplayers involved in providing pharmaceutical education, training and services. The principle changes relate to the establishment of the permanent South African Pharmacy Council and to the ownership of pharmacies, allowing non-pharmacists to own pharmacies. Changes have also been made in respect of the authorities responsible and the procedure for licensing pharmacies. Further, the powers of the Council have been increased in terms of pharmaceutical education and training. The Act is also made applicable to the State. Previously, the public service was not regulated under this Act.

In terms of implementation, the Minister of Health will determine the date on which the new Council will come into operation. This date will be published in the Government Gazette. Members of the IPCSA will remain until the new Council has been constituted. Provision is also made for parts of the Act to be phased in at different times.

4.1 Composition and functions of the SA Pharmacy Council

The Bill dissolves the Interim Pharmacy Council, and establishes a permanent council. The new council is to be named the South African Pharmacy Council, with its head office in Pretoria. The Council is to be composed of 25 persons, as follows:

- 9 pharmacists, elected by pharmacists,

- 9 pharmacists, nominated by the MEC responsible for health in the provinces,

- 1 officer of the Department of Health, appointed by the Minister,

- 2 pharmacists, who are staff of a university, appointed by the Minister,

- 1 person versed in law, appointed by the Minister, and

- 3 other persons, appointed by the Minister.

The Council will be responsible for:

• advising the Minister on issues relating to pharmaceutical practise;
• promoting the provision of pharmaceutical care in both the public and private sector;
• maintaining, developing, and controlling acceptable standards in pharmaceutical education and training, and professional conduct;
• establishing professional boards for "auxiliary pharmaceutical staff";
• registration of pharmaceutical personnel;
• prescribing the scope of practise for various categories of persons registered, such as pharmacists and pharmacy assistants; and
• disciplinary matters. The Council can institute inquiries into allegations of unprofessional conduct against any person registered with it.

The powers of the Council have been increased in respect of procedural matters, including appointing committees and co-opting members onto the Council. It can also determine fees payable to it.

4.2 Ownership and Licensing of Pharmacies

The Bill allows for the ownership of pharmacies to be more accessible. Previously, only pharmacists could own pharmacies. In terms of Section 14 of the Bill any person, except a health professional registered under the Medical, Dental and Supplementary Health Professions Act (Act No. 56 of 1974), may own a pharmacy. However, all pharmacies, whether owned by a pharmacist or non-pharmacist, must be under the continuous supervision of a registered pharmacist. The name of this supervising pharmacist has to be displayed conspicuously over the main entrance of the pharmacy. The supervising pharmacist is also responsible to the Council for any acts performed by or on behalf of the pharmacy.

All pharmacies have to be licensed. The Director-General is responsible for licensing the premises where such a business will be carried out. The Director-General can also determine the conditions under which the license is issued. Further, the Director-General may cancel or suspend any license.

The procedure for licensing is laid out as follows:

• A person/body wanting to do business as a pharmacy has to apply to the Director-General for a license.
• The Council will inspect the premises, and the registrar will provide the Director-General and the applicant with a written report if the premises are not suitable.
• The Director-General will issue the license, if the premises are suitable.
• The applicant must notify the Council of the receipt of the license. The Council must then record the name, address, license number, and other information which may be prescribed.
• Pharmacies which exist when this Act comes into effect will also have to apply for licenses.

4.3 Education

The Council, in consultation with the Minister, will establish and control pharmacy education and training. The Council will authorise institutions and persons which offer education and training to persons who wish to qualify for registration. It will also prescribe the unit standards of pharmacy education and training, in accordance with the South African Qualifications Act, and will lay down the conditions under which education and training should be provided. The Council will also provide the framework for education and training requirements for registration in the different categories of pharmaceutical personnel. It is further empowered to make regulations relating to educational requirements and evaluation for continued registration. The Council will remain responsible for determining the education and training which needs to be completed by health professionals, registered under the Health Professions Act, who want to dispense medicines.

5. Response to the Bill

The Portfolio Committee on Health held an initial hearing on 21 May 1997. It heard submissions from the Department of Health and the IPCSA. The Department indicated that different parts of the Act needed to be implemented at different times because some state facilities need to be improved before they would be eligible for licenses. In respect of the deregulation of pharmacy ownership, the Department believes that the proposed legislation will separate the practice of a profession (viz. pharmacy) from the practices of a business. It also believes that this provision, in addition to the training and registration of auxiliary pharmaceutical personnel, should increase access to medicines.

The IPCSA stated it’s full support for the NDP. In this regard it outlined its comprehensive human resource development programme, which aims to improve the training of pharmaceutical personnel. It emphasized in particular, the improved training for auxiliary personnel, who will provide pharmaceutical care. This is important, given the shortage of trained pharmacists in South Africa. The IPCSA also voiced its displeasure at not having been consulted before the final draft of the Bill was tabled in Parliament. It objected to licensing of pharmacies being the responsibility of the Director-General. Instead, it proposed that this responsibility be placed with the Minister, who could then delegate it.

It was mentioned that the Department and the IPCSA have reached agreement on some issues, since the tabling of the Bill in parliament. This relates particularly to the wording of some sections of the Bill in order to tighten up the legal loopholes.

6. Some Issues Raised by the Bill

The Bill proposes significant changes to the present system of pharmaceutical care. In particular, it provides for improved education and training of pharmaceutical personnel, and establishes a Council which is more transparent and representative. However, some issues are also raised by the proposed legislation.

• In respect of the composition of the Pharmacy Council, community representation of non-pharmacists is not stipulated. This differs from legislation governing the Health Professions Council and the Nursing Council. Should this provision be included in this Act?

• In terms of the NDP, inspection of pharmacies were devolved to the provincial health authorities. However, under this bill the Council is responsible for inspecting pharmacy premises. Is this role acceptable? Does the Council have the resources to carry out this task, given the greater numbers of applications envisaged. And if the provincial health authorities are given this task, will they have the resources to accomplish it?

• The Council is responsible for inspecting pharmacy premises and the Director-General is responsible for issuing the licenses. Are these roles acceptable? Also, how is communication between these two authorities envisaged, in order to make the process efficient.

• The Bill makes it possible for anyone, including corporations, to open pharmacies. The Department believes that this will improve access to medicines. However, how will this effect smaller businesses?

• The supervising pharmacist, as a registered member of the Council, is held liable for his/her actions. The responsibilities of the business owner, however, are not outlined in this Act. What responsibilities are envisaged for the owner? Will a pharmacy business be treated like any other business? How will the owner be held accountable for unscrupulous acts, or acts which may not be in the best interests of the public?

• The proposal is that the Bill will be dealt with in terms of section 75 of the Constitution. This means that it will be sent to the NCOP for a vote, but will not be sent out to the provinces for further consultation. Is this acceptable to parties?

7. The Way Forward

The National Assembly Portfolio Committee on Health will hold public hearings on the bill on 9 June 1997. The deadline for written submissions is 5 June. The second reading and National Assembly vote is scheduled for 17 June.

 

For more information, please contact Carnita Ernest at (021) 696-4954, or by fax at (021) 696-9308, or by e-mail at philaw@wn.apc.org . PHILA is supported by a grant from the Henry J. Kaiser Family Foundation.

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