The implications of amendments to Section 22 of the Pharmacy Act and new ownership regulations on “pre-May 2003” pharmacies
In terms of section 22(9) of the Pharmacy Act, 53 of 1974, under the section title “Licensing of pharmacies”, a “person registered to carry on the business of a pharmacy at the commencement of this Act shall be deemed to be licensed in terms of section 22(1) of the Act.”
Given the amendment made to section 22 of the Act in 2003, pharmacies who were registered only with the South African Pharmacy Council (SAPC) as per the old requirements, are deemed to be registered but are required to submit an application for a pharmacy licence to the Director-General of the national Department of Health (NDoH) in the event that the pharmacy changes ownership or relocates to new premises.
Prior to the licensing of pharmacies in terms of section 22 of the Act and the corresponding regulations, pharmacies were required to be registered only with the South African Pharmacy Council. There was no criteria for inter alia the determination of need for the pharmaceutical services in the proposed area of operation. This changed with the implementation of the Ownership Regulations. In the old dispensation, if a pharmacy thus moved premises, the pharmacy owner was required to notify the SAPC of such move, which would then ensure the new premises are inspected and a new certificate of registration issued. This changed with the amendment of section 22 of the Pharmacy Act, and resulted in all registered pharmacies at commencement being deemed to be registered. However, these pharmacies were not issued with a pharmacy licence by the NDoH in terms of the new regulations.
This gave rise to three challenges, for example, the registration details of pre-May 2003 pharmacies did not meet the requirements of the new regulations as ownership and location details were not clearly recorded; the NDoH has no record of the pre-May 2003 pharmacies bearing a licence number; and it became difficult to determine need for pharmaceutical services for the purpose of assessing an application for relocation.
It has come to the attention of of the SAPC and the NDoH that, contrary to the requirements as set out in the amendment to section 22 of the Pharmacy Act and the Ownership Regulations, some pre-May 2003 pharmacies that change ownership and/or relocate to different premises, do this without submitting a formal application to the Director-General of NDoH.
In 2015, Council deliberated on how best to manage this dilemma and resolved all pharmacies registered prior to 2 May 2003 be required to obtain a licence from the NDoH and to record such licences with the SAPC at no charge, provided that the pharmacy was still at the same premises as at 2 May 2003 and the ownership had not changed.
In an effort to efficiently carryout the Council decision, the Office of the Registrar wrote letters to owners and responsible pharmacist for Pre-May 2003 Pharmacies requesting them to confirm the following:
- if the physical address of the pharmacy reflecting on Council’s register is correct as per the actual physical address of the pharmacy; and
- if the pharmacy is still owned by the same owner as reflected on Council’s register.
The Office of the Registrar saw the need to acquire this information for maintenance of the register of pharmacies in anticipation of the project for the issuing of licences for Pre-May 2003 pharmacies, where there was no change of ownership or relocation after 2003;
While a few Pre-May 2003 pharmacy owners confirmed to have changed ownership and/or relocated to new premises without applying for a pharmacy licence, as they were under the incorrect impression that they were exempt from the Ownership Regulations and amendments to section 22, most of the feedback received confirmed that a number of these Pre-May 2003 pharmacies had not changed ownership or relocated since the amendment to section 22. Council is engaging the NDoH on a seamless process that can be undertaken on the issuing and recording of pharmacy licences for these pharmacies at no charge. Pharmacies who had relocated or changed ownership have been provided with licence application forms.
The Office of the Registrar urges all Pre-May 2003 pharmacies that have changed ownership and/or relocated since May 2003, to apply for a pharmacy premises licence at the Department of Health for the particular change and complete the SAPC online application form for the recording of pharmacy premises accessible on our website: www.sapc.za.org. The application form for a pharmacy licence is accessible from National Department of Health website, on the link: http://www.health.gov.za/index.php/affordable-medicines
Pharmacy owners and responsible pharmacists that are affected by these changes are advised to contact the Office of the Registrar should they require further clarity. The SAPC hopes to finalise this matter by the end of 2018. Once finalised, it will be expected that all pharmacies be in possession of a licence issued by the Department of Health and recorded with the SAPC at the time of an inspection.