Accessing Section 21 medicines

We live in an ever-evolving world with state-of-the-art technology and medicines developed daily. However, many of these new medicines are not registered in South Africa yet, but this doesn’t mean you can’t access them. Carel Bouwer explains the process to attain such medicines, known as Section 21 medicines.

All new medicines and technologies need to go through a thorough Medicines Control Council (MCC) registration process to prove their quality, efficacy and safety for treatment in human use, before they can become commercially available.

Researchers around the world are working to find better ways to prevent, detect and treat breast cancer, and to improve the quality of life of patients and survivors. Some of the newer treatment options include:

Oncoplastic surgery is the combination of breast surgery and plastic surgery techniques. This typically involves reshaping the breast at the time of the initial surgery, and may mean operating on the other breast as well to make them more alike.

Targeted therapy medicines are a group of newer medicines that specifically target gene changes in cancer cells that help the cells grow or spread. Trastuzumab is a targeted therapy medicine that is already being used to target HER2.

Bone-directed treatments are medicines that can help treat the spread of cancer to the bones, and might even help prevent it. Examples include pamidronate and denosumab.

These are only a few of the new treatment options, and these innovative medicines are normally approved in the international market after successful clinical trials. Unfortunately, South Africa is a small market in comparison to European and American markets, resulting in multinational companies sometimes filing later for registration in South Africa.

South Africa also has a complex and long registration process, and a product dossier can take several years to be registered by the   MCC after being filed. This means that it will take several years for a product to become commercially available in South Africa, after launching in other international markets.

There is, however, a process by which your doctor can get special approval to immediately access medicine not registered here. All medicines and access to medicines are controlled by the law of medicines as mandated in Act 101 of 1965. Section 21 of Act 101 allows a prescriber to apply for special approval from the MCC for a medicine not available in South Africa. The act is defined as follows: Council’s responsibilities and liability when performing its function in terms of Section 21 act 101 of of 1965. In terms of this Section the Authority/Council may authorise the sale of unregistered orthodox medicine, complementary medicine, and veterinary medicine or device for certain purposes.

In order to obtain approval under Section 21 terms, your doctor (the applicant) would need to complete a Section 21 application form for you (the patient) who requires the medicine. The form consist of six pages:

Section A – Particulars of the applicant

Section B – Particulars of the company/ institution importing the unregistered medicine

Section C – Particulars of the patient

Section D – Particulars of the unregistered product

Section E – Informed consent

Section F – Progress report form

Once the form has been completed, both  you and your doctor have to sign the form.  It then needs to be faxed or mailed to the MCC; a R300 application fee is mandatory. The MCC then assesses the application form to ensure the product in question has been evaluated and registered by another reputable health authority. The approval process takes between one to three days.

The approval form will be faxed back to the applicant after evaluation.

As soon as the approval form is obtained, an authorised institute can import the product into South Africa and supply it to the patient. This could take a day or up to two weeks. All of the product details,  Section 21 application forms and package inserts can be supplied by a reputable company specialising in the supply of medicines under Section 21 terms, such as Equity Pharmaceuticals.

Access to products not registered in South Africa is essential and every patient has the right to the individual treatment they require. As a patient, it is important to be aware of the treatment options available, and to ensure you make an informed decision when discussing treatment  regimens with your doctor.

What are the costs? 

Each medicine will be quoted separately and pricing will fluctuate depending on exchange rate, international pricing and courier cost. Please request a price when applying.

Do medical aids cover Section 21 medicines? 

This depends on the medical aid and the decision they make on your individual case. Some medicines are funded, if there is no alternative. Your doctor will need to motivate for funding from the medical aid, and attach the Section 21 approval with the application.

What are the common breast cancer Section 21 medicines being ordered? 

Denosumab, pertuzumab, ado-trastuzumab emtansine and Abraxane.

Written by Carel Bouwer.