Medicines and Related Substances Amendment Bill [B6B-2014]: Department of Health briefing

Meeting report

Briefing by National Department of Health

The National   Department of Health (NDoH) briefed the Committee on the Medicines and Related Substances Amendment Bill. The briefing was undertaken by Dr Joey Gouws, Registrar of the Medicines Control Council (MCC) and Director of Inspectorate and Law Enforcement in the NDoH; assisted by Ms Malebona Matsoso, Director General of the NDoH. Ms Matsoso kicked off the briefing with a brief overview.

Act 72 of 2008 amended the Medicines Act 101 of 1965, however when it came to the 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 MCC, but 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 required to be done.

Dr Gouws continued with the actual briefing. 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. An explanation was given on the establishment of the new medicines regulatory authority and what the objectives of Act 72 of 2008 had been. The decision had been 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 & approval and oversee all regulatory functions and 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.

Discussion

The Chairperson asked whether the NDoH had amended what was required to be amended in Act 72 of 2008.Shortcomings had held back the implementation of Act 72; the Act needed to be implemented. 

Ms Matsoso confirmed that all the necessary amendments needed were made. When the business case for the SAHPRA was developed issues that were lacking in the Act had been identified. Some of the amendments were improvements in administration relating to processes and procedures. Since 1965 there had been multiple amendments. The intention was for the SAHPRA to clean up everything.

Dr Barbara Loots, Parliamentary Law Adviser, said the Bill was a very technical piece of legislation. The Bill was putting into place a body to perform functions and would address the implementation problems of Act 72 of 2008 Act. She, together with the Committee Researcher and the Committee Content Adviser, had checked on constitutional issues pertaining to the Bill and the Bill had passed constitutional muster.

Ms L Mathys (EFF, Gauteng) asked why the DOH did not simply strengthen the MCC instead of setting up the SAHPRA. What was the need to dissolve the MCC? If a name change was needed then it could have been done. If the MCC were strengthened then there would have been no need for transitional arrangements. She asked what material difference the Board of the SAHPRA would make. She was concerned about the financial implications of forming the SAHPRA, and noted that the Department of Health in the North West had already been placed under administration due financial problems.

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. For example if there were 2000 applications for the registration of a medication and one was perhaps a cure for cancer then it would take three years to register. The MCC was furthermore a council of 25 experts. Ms Gouws was the Registrar of the MCC whilst also being an official of the NDoH. The MCC had no staff. She elaborated on the process relating to the eventual registration of products. Before a product could be registered it first went through research and development. The amount of data generated would be huge. Once a product was registered it went through pharmaceutical formulation. If a tablet needed to be made into a liquid form for children or there was a need for it to be in injection form then the product’s registration needed to be amended to give effect to the different forms of the product. Even when the ownership of a company that owned a product changed then there was a need to amend its registration. A great deal of administrative work had to be done, which was done by the staff of the NDoH, as the MCC had no staff. The current staff lacked capacity hence external experts were used that were full-time employed at tertiary institutions and only worked on a part-time basis to deal with applications, hence the huge backlog. With the formation of the SAHPRA there would be full-time experts employed to deal with applications. The MCC currently had 25 members and the intention was to trim down the number to between 10 and 12 members. The SAHPRA was to have governance and an oversight role. The NDoH had done an analysis of various regulatory models throughout the world and SA was considered the only country with this type of model.

A name change would not be good enough. The SAHPRA was a body that was being built and put in place. Staff was being identified and being trained. The staff of SAHPRA was going to be full-time employees. At present the MCC was relying on professors from universities to work for it on a part-time basis. This lengthened the time it took to evaluate applications. Full-time staff was needed to process applications.  Zimbabwe was good at registering generic products but not good at registering new chemical entities. This applied to other African countries as well. Many of them relied on SA. Current NDoH staff would be moved over to the MCC.

The Chairperson of the KwaZulu-Natal Portfolio Committee on Health, Ms L Shabalala, asked on which country’s model was the SAHPRA based. If the MCC had delays and backlogs what was the average turnaround time for applications. Some traditional leaders had complained that the turnaround time for applications was long and took forever. Was the MCC being replaced or was it being strengthened? She asked whether it was a good idea that the legislation allowed the Minister to step in when the MCC was unable to meet.

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.

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. Act 72 of 2008 only made provision for a Chief Executive Officer (CEO) who made all the decisions. There was no governance structure in place. The Bill would allow for a governance structure that would oversee the work of the CEO and of staff.

Ms Mathys asked whether the turnaround times for applications were four years. 

The Chairperson in closing asked that the NDoH support Members as they took the Bill to the provinces.

The meeting was adjourned.