Why SA’s medicines regulator should consider affordability

Of the total number of people on antiretroviral treatment (ART) in the public health sector, 75.8% are taking the three-in-one combination of the antiretrovirals tenofovir, lamivudine and dolutegravir (TLD for short)

By Tendai Mafuma and Nomatter Ndebele

Before any medicine can be sold in South Africa, it has to be approved by the South African Health Products Regulatory Authority (SAHPRA), who certify that the medicine is safe, of good quality and is effective. Unless the medicine has gone through these processes, it cannot be on the shelves for sale. In exceptional circumstances, SAHPRA may permit access to unregistered medicines. This exception is permitted by section 21 of the Medicines and Related Substances Act, 101 of 1965 through a process that is commonly referred to as “a section 21 application”.

Section 21 applications are typically used to access an unregistered medicine in circumstances where there is no version of that medicine that has been registered in South Africa. An example of this could be where registration of the medicine is pending but there is a need to urgently access that medicine in order to save lives. This was the case during the height of the HIV/AIDS pandemic, when organisations such as the Treatment Action Campaign used section 21 applications to get access to fluconazole for the treatment of HIV-related opportunistic infections. This provision may also often be relied on where a patient has sufficiently justified why they cannot use the registered product, for example if a patient can show that the unregistered alternative is not only superior in terms of safety and quality standards but will also have superior therapeutic effect on their health.

One of the questions that comes up regularly is whether the fact that a registered medicine is excessively priced is sufficient justification for seeking section 21 access to an unregistered alternative. Over the past decade, individual patients have sought access to unregistered medicines on the basis that the alternatives registered in South Africa are excessively priced, and therefore inaccessible. SAHPRA has routinely declined authorisation of the applications on the basis that cost is not a factor to be considered. Put simply, according to SAHPRA, if there is a registered medicine in South Africa, that would be effective for the diagnosed condition, you cannot request access to an unregistered alternative solely on the basis that you cannot afford the registered medicine. This means that if patients cannot somehow find money for the registered treatment, they will not access any treatment.

People with chronic health conditions such as cancer are particularly affected by this. We use cancer as an example because due to the astronomical costs of cancer medicines, very few patients are able to gather the money required for new cancer medicines.

Take for instance Hayley Stols who was diagnosed with stage 4 malignant metastatic myeloma. Her oncologist recommended treatment with Opdivo, a drug that was not registered in South Africa. At the time, there was a registered drug, Pembrolizumab which would have cost R1,8 million per year. Opdivo, on the other hand, would have cost R770 000 per year if purchased from the Netherlands. Whichever option Hayley chose, it would have had to be self-funded as neither medicine was covered by her medical aid scheme. It is difficult to imagine anyone in South Africa who has R1,8 million per year for one course of treatment. R770 000 is still a lot of money, but it is significantly less than R1,8 million.

Hayley made two section 21 applications to SAHPRA to request permission to access Opdivo. In both applications, she clearly stated that the reason for this request was that Opdivo was more affordable. Both applications were rejected.

There are a few exceptional cases where SAHPRA has approved section 21 applications on the basis of cost, for example applications by MSF for access to the TB medicine linezolid, but the fact is most of these applications are rejected. Patient advocacy groups have been trying to engage SAHPRA on this issue with little success.

In the past, SAHPRA has argued that the law does not empower it to make decisions based on cost and that its only mandate is to consider the “safety, quality, and therapeutic efficacy” of medications. This, in our view cannot be the only consideration.

Firstly, the Constitution doesn’t only guarantee the right to access to health care services, it also requires the State to take reasonable measures, within available resources, to achieve progressive realisation of the right. It also places an obligation on organs of state such as SAHPRA, to respect, protect, promote and fulfil fundamental rights. Moreover, the Constitution states that legislation must be given an interpretation that promotes the spirit, purport and objects of the Bill of Rights. This means that laws must be interpreted in a manner that will allow the enjoyment of rights to the fullest possible extent. As an organ of state responsible for ensuring that consumers have access to safe, quality and effective medicines, SAHPRA’s interpretation of the law should not be one that effectively hinders access to healthcare.

It also means that SAHPRA must develop and implement policies that do not undermine access to medicines. At the most basic level, access to medicines refers to the ability of all persons to receive the medicines necessary for the treatment of any condition affecting them. It entails physical, informational and economic access (i.e. affordability). This interpretation of access to medicines has been laid out by the courts. If SAHPRA does not concern itself with practical concerns about whether patients can afford medicines, that is tantamount to a failure of its duty to respect, protect, promote and fulfil the constitutional right to have access to medicines.

Considering affordability does not mean that SAHPRA must turn a blind eye to considerations of safety, quality and efficacy. Neither will it open the flood gates of section 21 applications as patients seek access to unregistered medicines even where the price difference is marginal. Rather, it requires an acknowledgement that there can be no access if the medicines are priced excessively and beyond the means of those who need them.

SAHPRA recently published a guideline aimed at ensuring that section 21 applications are received, processed effectively and consistently, and decided timeously. Despite SAHPRA already having dealt with several section 21 applications based solely on cost, the guideline makes no mention of how the entity intends to resolve such applications. Given the constitutional obligations, we think that it is about time SAHPRA begins to concern itself with matters of affordability of medicines. Failing to do so would be a failure to ensure access to medicines and a violation of the right to access health care services.