Cape Town - Minister of Higher Education Blade Nzimande faced tough questions in Parliament on whether the state-owned pharmaceutical company known as Ketlaphela has been established.
In a question and answer session, DA MP Chantel King sought clarity on the latest relevant information regarding the development of the company and the total amount which has been spent in the planning and development processes of establishing the company.
Nzimande said Ketlaphela SOC Ltd was established as a subsidiary of Pelchem SOC, a subsidiary of South African Nuclear Energy Corporation.
“The establishment of Ketlaphela was part of the vision to manufacture active pharmaceutical ingredients (APIs) for drugs against the most problematic diseases in South Africa, in particular HIV/Aids. This was part in a process of many other activities and investigations into the sustainability of such an entity which included a number of studies, and the establishment of public private partnerships seeking expert and legal opinions. Much work in this regard was done between 2011 and 2014. In total, the process was done in three phases.”
The minister said that the first phase entailed a partnership with Lonza but that Lonza withdrew, citing the new management team’s global “focus and deliver” strategy, which they said would not align with the partnership on Ketlaphela.
Following Lonza’s withdrawal, Nzimande said the Cabinet approved a process to find a new technology partner. This was referred to as Phase 2 of Ketlaphela.
“The need for finding yet another partner was based on the fact that all APIs used in drug formulations in South Africa are imported and as such, a technology partner would facilitate technology and skills transfer. This phase was implemented through open calls for expressions of interest. Unfortunately, no bidder could meet the minimum qualifying criteria. The collapse of this phase ushered the process into the third phase.”
The third phase entailed a more pragmatic approach.
Nzimande said that Ketlaphela-branded antiretroviral tablets (ARVs) would be introduced into the national health-care system through a collaboration with local ARV producers, while a small-scale manufacturing plant for APIs for selected niche products, including new ARV APIs, would be established.
“The third phase could not proceed as the letter of intent for long-term supply contract could not be secured. However, the research, development and innovation aspect under the Department of Science and Technology continued and the small-scale manufacturing plant for API manufacturing has been established.
“As from 2017, the Pelchem board decided to take the process forward by finding an international technology partner to provide finished products under the Ketlaphela brand. The Department of Science and Innovation is not part of this process as it does not follow the original aspect of local development and manufacturing of APIs.”
Nzimande said for the period 2011 to 2015, the Department of Science and Technology funded the establishment of Ketlaphela to an amount of R13 747 152.
“It is important to note that the services as procured in this regard during the three phases were rendered and as such, funds were utilised for specific deliverables. At the end of the contract between Pelchem and the Department of Science and Technology in March 2017, the unspent amount of R4 836 272.29 was refunded.”
He added that Ketlaphela was therefore left existing just in name, without assets, and no funding was inherited from the establishment process.
“The process currently being pursued by Pelchem and the Department of Energy and Mineral Resources to take the process forward in a different format seems to have stalled. With the Department of Science and Innovation not being part of that, the department is therefore not in a position to provide an update on the latest developments.”
Political Bureau