The Competition Commission of South Africa recently published a media statement on cystic fibrosis medication access – Trikafta. This article highlights improvements in access to Trikafta, a critical medication for cystic fibrosis patients. Access to Trikafta has been primarily enhanced through the mechanisms established by Vertex Pharmaceuticals which has passed a review by the Competition Commission of South Africa.

Section 21 of the Medicines and Related Substances Act

– Section 21 allows SAHPRA to authorize the sale of unregistered medicines in South Africa under certain conditions. This provision enables registered medical practitioners to apply for approval to use unregistered medicines, such as Trikafta, for individual patients.
– In the context of Trikafta, Vertex has committed to making this medication available through Section 21. This approach allows patients in South Africa to access Trikafta even if it is not fully registered with SAHPRA.

Patient Access Program and Financial Assistance

– Vertex launched a patient assistance program, managed by an NGO, to reduce financial burdens on eligible patients. This initiative ensures that some cystic fibrosis patients can access Trikafta at no cost.
– Eligible patients under specific medical schemes can access Trikafta for free through financial assistance. This includes support from top-end medical plans offered by Discovery Health.

Impact on Access to Medicine Initiatives

– The decision by the Competition Commission to accept Vertex’s undertakings and non-refer the complaint is viewed as a positive outcome for access to medicine initiatives in South Africa. It guarantees that patients can access life-changing medications like Trikafta locally, at a more affordable price than before.
– The local distribution of Trikafta, starting in April 2024, significantly enhances the medication’s accessibility. Patients will no longer have to import it from other countries, aligning with public interest and the objectives of the Competition Act.

Conclusion

Overall, the initiatives undertaken by Vertex, reviewed by the Competition Commission, represent a marked improvement in access to Trikafta for cystic fibrosis patients in South Africa. The implementation of Section 21 authorizations and patient assistance programs makes this critical medication more accessible and affordable, which is a positive advancement for access to medicine initiatives in the country.