Novecy may compound meds
The ruling means that Methealth and the related medical funds must cover Novecy's compounded medication.
A compounding pharmacy in Windhoek may continue to compound medicines to meet Namibians' existing and foreseeable needs. Novecy Pharmacy may also continue to facilitate access to compounded medications for Namibian patients and healthcare providers.This is the crux of Judge Shafimana Ueitele's ruling in a claim that Novecy filed in the high court against, amongst others, the Namibia Medicines Regulatory Council (NMRC), Methealth Namibia Administrators and the registrar of medicines.
The claim followed a decision that the pharmacy was not legally allowed to sell and distribute their compounded products that were compounded against a valid prescription. The NMRC as well as the registrar of medicines (third respondent) and Methealth Administrators (Pty) Ltd. (fourth respondent) gave the instruction not to pay out any claims for medication compounded and sold by Novecy. Methealth is the administrator of three medical funds.
However, Ueitele's ruling means that Methealth and the related medical funds must now cover Novecy's compounded medication.
Compounded medications are generally more affordable than commercially manufactured medications. The NMRC claimed that regulation 19(2) of the regulations relating to medicines and related substances requires that compounding must be done "extemporaneously". Because Novecy does not do it that way, according to the NMRC, their compounded medication amounted to "small-scale manufacturing" and was therefore illegal.
However, in his judgment, Ueitele declared this regulation to be contrary to the law and set it aside, which means that the above requirement no longer exists.
Novecy's compounding pharmacist Riana Potgieter emphasised in her testimony that the pharmacy fulfills a critical function of providing compounded medicines to patients who would otherwise not be able to afford such medicines or find them at other pharmacies.
Should manufactured or generic medicines not be available in the country, pharmacies have no alternative but to purchase them as formulated by Novecy. If they don't, patients are without their medication, which can be highly risky for their health.
Potgieter also referred to cancer treatment, in particular chemotherapy, which is often not available in the country. As a result, the Namibia Oncology Center (NOC) purchases the compound chemotherapy from Novecy. Examples of essential medications compounded by Novecy include a drug that fights nausea in patients receiving intravenous chemotherapy, syrup used to prevent babies of HIV-positive mothers from getting the virus through birth or breastfeeding, as well as an antidepressant that was taken off the Namibian market in 2019.
During Potgieter's sworn testimony, the above was not registered in Namibia nor was it available on the commercial market.
Novecy is affiliated with two of the three largest compounding groups in the world, Fagron and Medisa, which are strictly regulated in their own countries and also according to European and American standards. The pharmacy also has an import licence as required by law for medicines and related substances which grants permission to import raw materials used in medicines (substances) which are scheduled or not. In the case of importing schedule 3 and 4 substances, Novecy obtains the required additional permit. – [email protected]