Bill [B6B-2014] Department of Health briefing held on 25 August 2015
What happens when an Act needs to be amended? At a recent briefing by the National Department of Health (NDoH) to the NCOP Social services Committee in Parliament on the Medicines and Related Substances Amendment Bill, I found out.
The Medicines Act 101 of 1965 was amended by the Medicines Amendment Act, 2008 (Act 72 of 2008). However when it came to proclamation it was realised that there were gaps in governance. Every country in the world had a medicines regulatory body and in SA it was the Medicines Control Council (MCC). Unfortunately, no provision had been made in the 2008 Act for a governance structure; reference was only made to a regulatory body. There were also purely technical changes in the definitions in Act 72 of 2008 that were required. SA’s policy and legislative framework relating to drugs and medicines was touched on. The Committee was given insight into the MCC’s mandate, its obligations and detail on how the MCC worked.
Another problem with the original Act was that the MCC was a council of 25 experts, but with no staff. Ms Gouws was the Registrar of the MCC whilst also being an official of the NDoH. The new entity SAHPRA as detailed below would have its own staff and more resources to solve many of the MCC problems and backlogs.
An explanation was given on the establishment of the new medicines regulatory authority and what the objectives of Act 72 of 2008 were. The decision was taken in 2007 to establish the South African Health Product Regulatory Authority (SAHPRA) as an organ of State within the public administration but outside of the public service. It would regulate medicines and medical devices. Members were given insight into the principles and objectives of Act 72 of 2008. Even though Act 72 of 2008 had been approved by Cabinet and Parliament and signed into law by the President in 2009; it had not yet been implemented.
The NDoH elaborated upon the objectives and reasons for the current Bill. Some of the reasons were to strengthen governance provisions for the proposed SAHPRA, as a Schedule 3A Public Entity, to provide for the establishment of a Board, to provide for the functioning of the SAHPRA under the Board, to strengthen transitional measures to facilitate migration of the MCC to the SAHPRA, to provide for consequential amendments that replaced the MCC with the SAHPRA and to explicitly define the functions of the SAHPRA within the statute. The functions of the SAHPRA Board and of its Chief Executive Officer (CEO) were outlined. For operational reasons various transitional provisions were provided for to allow for the commencement date of the new Authority, the ceasing of the work of the MCC and the transfer and designation of the employees of the NDoH to the SAHPRA and processes related thereto.
To ensure effective functioning, the SAHPRA would be partly reliant on Government funding through public money by means of a transfer from the Revenue Fund and partly from funds/fees raised for services rendered within its regulatory ambit. The Committee was informed about remedial measures that had already been implemented by the NDoH.
SAHPRA would address challenges of access to quality, safe and affordable medicines and medical devices / in vitro diagnostics (IVDs), improve efficiencies in the current system, fast-track the registration of priority public products, make essential medicines and products more readily available, potentially reduce prices through increased competition and licensing of generic products.
The SAHPRA would have full-time in-house capacity to support product review and approval and oversee all regulatory functions; and would be responsible for monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, clinical trials and medical devices and related matters in the public interest.
All of this would improve an area that receives lots of criticism. I believe this is a move in the right direction.
The NDoH was asked whether the required amendments to Act 72 of 2008 had been done. Members felt that implementation of the legislation needed to happen. The Parliamentary Law Advisers Office informed the Committee that the Bill had passed constitutional muster. The NDoH was asked why it had simply not strengthened the MCC rather than setting up the SAHPRA. Ms L Mathys (EFF, Gauteng) asked if it would not have been more efficient and cost effective to strengthen the MCC? Ms Matsoso responded that there was a structural problem with the MCC. Its problems had been all over the media. The MCC had huge backlogs.
Members asked what the financial implications were for setting up the SAHPRA.
The NDoH had been asked on which country’s regulatory model the SAHPRA had been based upon. Ms Matsoso added that in some countries the registration of generic products took 6 months. The NDoH did have remedial provisions in place. Legislation allowed for the Executive Committee to meet.
Members asked if the MCC was experiencing backlogs and delays and what the turnaround time for the processing of applications for registrations was. Ms Gouws, on timelines and backlogs, pointed out that there were two types of registrations. There was firstly the registration of a new chemical entity. The new chemical entity was a new molecule for a specific product. It could for example be a new medication to fight cancer. The second type of registration was for generic products. These applications came in when patents had expired. The workload on registrations of new chemical entities was much more and the process could take 3-5 years. The registration of generic products normally would take 12 months but could also take between 36 months and 3 years. The processing of applications for registrations depended upon the quality of the application dossier received. Most of the applications received were for generic products.
I personally believe that the establishment of SAHPRA is a much needed improvement to the regulation and registration of medicines. It can only improve on the MCC, which to my mind is a real disaster at the moment.