Roche responds to TAC claims

Published on: 16 March 2017                  Source: Roche Media Release

SWISS drug maker Roche has responded to an article which appeared on the Health-e News service website on 7 March 2017, in which Ms Lotti Rutter from the Treatment Action Campaign (TAC) stated that Roche would block access to trastuzumab “by any means possible”. Roche believes that this statement is baseless, inaccurate and does not reflect the considerable efforts which the company has undertaken in South Africa to increase access to trastuzumab. Roche has met with members of the “Fix the Patent Laws” Alliance which includes representatives from the TAC, on more than one occasion, to share with them the steps which it has undertaken to address the issue of access to trastuzumab in the public sector.

In these meetings with the TAC it was explicitly stated that these steps included an offer to the Department of Health (DoH) which supports the testing of breast cancer patients in the public sector, and if positive for the HER2 gene, will make trastuzumab available for the treatment of these patients. The trastuzumab price which has been offered to the DoH is on par with trastuzumab pricing adopted in low-income countries such as India, thereby providing the DoH with a cost-effective option for the treatment of HER2-positive breast cancer. This treatment cost also compares favourably to the treatment cost which the “Fix the Patent Laws” Alliance uses as their benchmark for an affordable solution.

Despite these efforts, the “Fix the Patent Laws” Alliance continues to make misleading and incorrect statements regarding Roche’s actions and intentions, including consistently quoting incorrect prices at which trastuzumab is currently available in the public sector. In addition, Roche has expressed its commitment to partner with the “Fixe the Patent” Laws Alliance, as well as with other patient groups, to find collaborative solutions to other healthcare challenges that prevent patients with HER2 positive breast cancer from being able to access the care they need. In South Africa, these challenges include low awareness of disease and lack of access to diagnostic services. Roche has also, on a number of occasions, stated that although it holds a number of patents on trastuzumab, it will not necessarily oppose the entry of biosimilar versions of trastuzumab in South Africa, provided that these medicines meet the appropriate regulatory standards as set out by the South African Medicines Regulatory Authority (Medicines Control Council). Roche has a duty to its patients to ensure that products that a company claims are comparable have followed rigorous clinical and regulatory standards and have been assessed in relation to those standards. Roche will continue its efforts to increase access to trastuzumab in both the public and private sectors and will continue to work with all stakeholders, including patient groups to find collaborative solutions to the healthcare challenges in South Africa.

Source: Roche Media Release