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17 June 2020
On 22 May 2020 the minister of health, on the recommendation of the South African Health Products Authority (SAHPRA), issued Government Gazette 43346, which essentially exempts, under Section 36(1) of the Medicines and Related Substances Act 101 of 1965 (Medicines Act), the free supply of medicines, medical devices and in vitro diagnostics (IVDs) to the state for three years. This exemption also extends to the supply of samples to the state as part of a tender published by the state.
Notably, the exemption was signed by the minister of health on 24 April 2020 and takes effect from the date of signature. This raises questions as to whether this exemption is retrospective, having only been published on 22 May 2020.
The free supply of medicines (including samples) is regulated under Section 18B of the Medicines Act, which broadly states that "no person shall sample any medicine, medical device or IVD" and defines the term 'sample' as:
the free supply of products, medical devices or IVDs by a device or IVD establishment, manufacturer or wholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974 (Act No. 56 of 1974), or any professional or person authorized to use the device.
Although the term 'sample' refers to the free supply of 'products' as opposed to medicines, it is generally understood to include medicines. Prior to an amendment in 2015, the term 'product' was defined in the Medicines Act as "a medicine, a Scheduled substance or a cosmetic or foodstuff which contains a schedule substance". Accordingly, this general understanding of the term 'product', in the context of Section 18B as well as its history, do not contradict the provisions of Section 18B.
The wide-reaching terms of Section 18B have been generally recognised as precluding donations to the state since their inclusion in the Medicines Act in 2008. Many have questioned the basis of this amendment, particularly because the state has a duty under Section 27(1)(a) of the Constitution to provide "everyone with access to healthcare services", which has been recognised by the courts as including access to medicine. However, this prohibition can be detrimental to the state, especially in cases of natural disasters, epidemics, pandemics or other phenomena that have broad effects and where ready access to medicine for use in the public health sector is required to minimise the impact of such events. The COVID-19 pandemic and the state's duty to put into place measures to mitigate the effects of this declared national state of disaster under the Disaster Management Act 57 of 2002 are likely to have brought these issues to the fore.
In understanding the ambit of Section 18B of the Medicines Act, it is important to reflect on its history and the original wording of Section 18B prior to its amendment in 2008. Section 18B has always prohibited the sampling of any medicines; however, it expressly excluded the free supply of medicines for "clinical trials, donations of medicines to the State, tendering to the State and quality control by inspectors".
When the 2008 amendment to Section 18B took effect, the fact that there was no express exclusion for the free supply of medicines to the state created some confusion as to whether the latter falls within the scope of this prohibition. However, as indicated above, the absence of this express exclusion from Section 18B has ultimately been understood as an intention on the part of the legislature to include the free supply of medicines to the state within the ambit of the Section 18B prohibition.
Accordingly, it has been understood by the pharmaceutical industry that before a donation to the state can be effected, there must be an exemption in place that authorises the donation of that medicine (or scheduled substance) to the state. Fortunately, Section 36(1) of the Medicines Act empowers the minister of health, on the recommendation of SAHPRA, to exclude any medicines, schedule substances, medical devices or IVDs from the operation of any or all of the provisions of the Medicines Act. The minister acted in terms of this power when exempting all medicines, medical devices and IVDs from the provisions of Section 18B of the Medicines Act as reflected in the relevant Government Gazette published on 22 May 2020. It is now, for a period of three years, permissible for persons to make donations of these items to the state. However, any donation must be "made in accordance with the guidelines as determined by the [SAHPRA] and relevant procedures required by the State."
On 27 May 2020 SAHPRA published guidelines outlining the principles and processes that must be followed when donating medicines, medical devices or IVDs to the state. At the core of these guidelines is a recipient-centric approach, which requires the recipient to request donations and/or to specify its specific needs. Unsolicited donations or donations which arrive unannounced or are unwanted should be avoided. Donors are discouraged from making donations that are not aligned with the specific needs of recipients. Accordingly, medicines that are donated must appear on the Standard Treatment Guidelines and Essential Medicines List of the National Department of Health.
The guidelines are clear that any donated medicines must be registered according to the terms of the Medicines Act before being donated. Alternatively, SAHPRA must have granted the donor authorisation to donate an unregistered medicine in terms of Section 21 of the Medicines Act. This provision empowers SAHPRA to authorise the sale (and in this case donation) of unregistered medicines. Traditionally, Section 21 is used not as a mechanism for circumventing registration requirements of medicines on a mass scale, but rather in exceptional cases to allow for the supply of medicines on a compassionate basis to named (or small groups) of persons. Ordinarily, the recipient, usually a health practitioner, makes an application under Section 21. It remains unclear from the guidelines whether Section 21 will be applied restrictively in the case of donated medicines.
As regards medical device and IVD donations, those which have not been called up for registration with SAHPRA (to date, no call notices have been issued) may only be donated if they are sourced from a medical device or IVD establishment, manufacturer, wholesaler or distributor that is the holder of a licence issued in terms of Section 22C(1)(b) of the Medicines Act.
Other than these registration and licensing requirements, the guidelines specify other requirements for medicine, medical device and IVD donations to the state, including requirements relating to labelling and packaging, transport and quality assurance.
Although the guidelines are clear that donations that do not comply with its requirements will not be accepted, there is little built into the guidelines that indicates how these guidelines will be enforced (if at all). Before donating medicines, little more is required other than informing the "the government of South Africa through the Affordable Medicines Directorate of the NDoH" about a medicine donation that is prepared or actually under way. More is required in the case of medical device and IVD donations – SAHPRA must approve the donations in advance. Presumably, where medicines, medical devices and IVDs are imported into the county, there will be some level of ensuring compliance with these guidelines at ports of entry; however, it is difficult to know what condition locally donated medicines to the state will be in, and how and who will accept or reject these donations.
Notwithstanding some of the issues presented in the guideline issued by SAHPRA on donations to the state and the fact that it remains unclear why donations to the state were originally prohibited in terms of Section 18B of the Medicines Act, in light of the current circumstances and focus on managing the effects of the COVID-19 pandemic, which goes hand in hand with access to healthcare resources such as medicines, the issue of this exemption is a clear step in the right direction.
For further information on this topic please contact Altair Richards or Alexandra Wood at ENSafrica by telephone (+27 11 269 7600) or email (firstname.lastname@example.org or email@example.com). The ENSafrica website can be accessed at www.ensafrica.com.
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