SARRAH is supporting an important initiative to improve access to medicines in South Africa.
The first stage of this initiative, the ‘Backlog Project’,
provided an audit of the backlog of applications to register medicines with the Medicines Control Council (MCC). The next stage of the initiative involves the establishment of a new medicines regulatory authority, the South African Health Products Regulatory Authority (SAHPRA).
Phase One of SAHPRA included the establishment of the project in a newly-renovated building shared with the National Department of Health. This also involved upgrading the registry filing systems and installing around seven kilometres of shelving. The infrastructure and systems for the new entity were conceptualised and a master plan developed. A team of consultants was recruited and an industry forum for consultation established.
Phase Two of the SAHPRA project began in November 2010. This involved meeting the statutory requirements of the new entity and the additional work needed to establish it. Good progress was been made in change management, establishing a labour forum to deal with organised labour, and many other aspects of organisational design.
In November 2011 Cabinet gave the green light for the establishment of SAHPRA and confirmed that it will become a public entity. The precise details of how this will happen will be agreed between the Ministers of Health and Finance and the National Treasury. The Minister of Public Service and Administration will also have to agree to the conditions of service of the CEO and the human resources policies of the Authority.
Cabinet also agreed to changes in the regulatory legislation (Medicines and Related Substances Act 72 of 2008), which needs to go back to Parliament during the first half of 2012.
In the meantime planning for SAHPRA can continue. It will be impractical to attempt to implement the entire new entity at once and there is no need to wait for the definitive SAHPRA Act to implement a more efficient administration for the regulatory authority. Therefore during Phase Three of the project the team will focus on designing the detail to make SAHPRA an operational reality. Between January and the end of July 2012 the project team will focus on:
- Confirming the constituent parts of SAHPRA and what this means from an operational perspective in terms of HR, IT and Finance;
- Developing a set of detailed guidelines and operational polices for the new public entity; and
- Advising NDOH about the legal and practical steps that should be taken to operationalise the new entity between the completion of the design phase and the listing of the public entity.
There are many elements to manage in order to successfully shift from the current medicines regulatory authority to the new SAHPRA with its expanded mandate. The final design for SAHPRA and resulting high-level transitional plan will provide existing management with sufficient insight into how to migrate and implement SAHPRA. For example: how to ensure that services are not disrupted (or that there is very minimal disruption). Steps for implementation and managing the transitional phase will form a substantive part of the final design document due at the end of July 2012. It is envisaged that active implementation will start at the end of this project phase.
Changes to SA’s medicines regulatory authority. Read…
The Backlog Project. Read…
Project Briefs on SAHPRA. Read…