NHI Bill: Negotiating Mandates; African Medicines Agency Treaty; with Minister

Meeting report

Chairperson’s opening remarks
The Chairperson reminded the Committee about the legislative process so far for the National Health Insurance (NHI) Bill in the National Council of Provinces (NCOP). The NHI Bill, tagged as a Section 76 Bill, was referred to the Committee on 13 June 2023. The Committee received its first briefing on 20 June 2023 from the National Department of Health (NDoH). Thereafter, the Committee embarked on a public participation process by calling for written public submissions in print media across the country, in nine provinces, in 11 official languages and all parliamentary social media platforms, which took place from 2 August 2023. Subsequently, the Committee received requests from stakeholders and individuals for the extension of the closing date for written submissions. The Committee agreed to accept all submissions received by 15 September 2023. All provinces had briefings and public hearings between 28 July and 30 October 2023. The Department responded to the written submissions on 31 October, 7 and 9 November 2023. The Committee has scheduled a meeting for negotiating mandates for today, 14 November, and for final mandates on 21 November 2023 where the Committee will adopt its report on the Bill. He put this on record as the procedures the Select Committee had followed in processing the NHI Bill.

National Health Insurance Bill – Negotiating Mandates
The Chairperson asked the Secretariat to assist with sequencing the negotiating mandates.

Eastern Cape
Ms N Ndongeni (ANC, Eastern Cape) said Eastern Cape voted in favour of the NHI Bill.

Free State
Mr I Ntsube (ANC, Free State) said the Free State voted in favour of the NHI Bill.

Gauteng
Ms E Nkosi (ANC, Mpumalanga) said Gauteng voted in favour of the NHI Bill.

Kwa-Zulu Natal
Ms Ndongeni said Kwa-Zulu Natal voted in favour of the NHI Bill.

Mpumalanga
Ms Nkosi said Mpumalanga voted in favour of the NHI Bill.

Northern Cape
Ms D Christians (DA, Northern Cape) said the Northern Cape voted in favour of the NHI Bill.

Limpopo
Mr E Nchabeleng (ANC, Limpopo) said Limpopo voted in favour of the NHI Bill, with comments to be considered.

North West
Ms Ndongeni said the North West voted in favour of the NHI Bill.

Western Cape
The Chairperson said that as a Western Cape permanent delegate, he had not received the negotiating mandate for the Western Cape. However, the Committee had received a letter from the Western Cape requesting an extension to consolidate the submissions. The request was accepted, and Western Cape was allowed to submit on Friday, 17 November 2023.

The Chairperson said that the Committee would hear from the Western Cape in the next meeting, then the Committee would engage with the legislatures on 21 November 2023.

Minister's remarks
Dr Joe Phaahla, Minister of Health, showed appreciation of all the provincial delegates and the provinces for voting in favour of the NHI Bill and said that going forward the Department was going to avail themselves to continue to interact with all the provinces on whatever matters that may need further discussion.

African Medicines Agency (AMA) Treaty: briefing
Dr Moeketsi Modisenyane, NDoH Director: International Health and Development, gave a presentation on the ratification for the establishment of African Medicines Agency Treaty. The Department was requesting that Parliament support and approve the ratification, as contemplated in Section 231(2) of the Constitution, 1996, as signed by the Cabinet. The highlights of the presentation were:

• There are 27 African countries that have ratified, with three governance structures established, which include the Conference of the States Parties (CoSP), AMA Bureau and the Governing Board.

• CoSP has been constituted and rules of procedure have been adopted.

• AMA is established to improve access to quality, safe and efficacious medical products through:
- Coordination and strengthening of ongoing initiatives to harmonize medicines regulation, promote cooperation and mutual recognition of regulatory decisions.
- Carrying out regulatory oversight of selected medical products and providing technical guidance to State Parties and Regional Economic Communities.
- Pooling expertise and capacities and strengthening networking for optimal use of resources.

• AMA’s four areas of focus:

Policy Alignment & Regulatory Reforms - Enhanced policy coherence in Regional Economic Communities (RECs) and AU member states for public health and pharmaceutical industry development. For example, three regions have adopted regional policies and legal frameworks for regulation of medicines including SADC.

Regional Integration and Harmonisation - Increased use of harmonized policies and regulatory frameworks by member states. For example, five regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards.

Human & Institutional Capacity Development - Increased human and institutional capacity for regulation of medical products and technologies. For example, African Regulatory Professional Fellowship Programme developed and administered.

Enabling Environment:  Coordination, Partnership And Resource Mobilization: Effective coordination and alignment of regulatory interventions with African Medicines Regulatory Harmonization (AMRH) and African Medicines Agency. For example, 50% of funding for AMRH initiative mobilized from other sources.

• Financial resources for the AMA in terms of Article 26 of the Treaty:
- Annual assessed contributions from state parties as set up by the CoSP
- Appropriate sanctions for State Parties that default to be determined by the CoSP in alignment with the AU Assembly sanctions regime.
- Other resource mobilisation mechanisms to include:
- Grants & donations from international organisation, governments, private sector, foundations and other entities.
- Proceeds from AMA activities.
- Resource mobilisation to be in alignment with guidelines set by the Board and CoSP.

• Pending the adoption of AMA Financial Rules by the CoSP, the AMA shall abide by the AU Financial Rules and Regulations where appropriate.

• The role of South Africa in terms of medicine regulation:

- South Africa (SAHPRA) is the current Chair of the AMRH Steering Committee.

- South Africa chairing the continental technical committee on Good Manufacturing Practice (GMP) inspection.

- SAHPRA is a Regional Centre of Regulatory Excellence in Vaccines Regulation.

- SAHPRA is currently a lead agency that is hosting the Continental Pilot on Joint Assessment of applications for registration of medicinal products.

(Further details can be found in the presentation attached.)

The Department recommended that Parliament approve the ratification of the Treaty for the establishment of the African Medicines Agency (AMA), as contemplated in Section 231(2) of the Constitution, 1996.

Minister's remarks
The Minister found the presentation compelling and it made clear the benefits to South Africa, the SADC region and the rest of the continent. The Cabinet had already signed for the country’s participation in the treaty but it was not yet ratified. The Minister thought it was important that the country participate and lead the treaty due to the fact that South Africa is held in high esteem by the African continent.

Discussion
Ms Ndongeni asked what would be the criteria for determining the annual contribution for member states and what was the implication of different countries having different annual contributions. When South Africa eventually completes the ratification, is the annual contribution going to be retrospective or not? She asked the Department to explain if the privileges and immunities in Article 8 of the OAU Convention General Convention on Privileges and Immunities and Additional Protocol implied that possible corruption would not be investigated. Can the Department quantify the real value that South Africa will gain from ratifying this treaty?

Ms Christians asked how AMA was going to ensure equitable participation and representation considering the possible differing annual contributions of the African countries. On the operations and accountability aspect, can the Department clarify the current staffing status of AMA. What will be the representation of all geographic regions to ensure that the staffing component is equitable?

Ms Nkosi applauded the Department on fulfilling its commitment to implement the comments from the provincial councils.

Minister's response
Minister Phaahla responded that the annual contribution had not been determined yet because there was a threshold for the number of countries that still needed to ratify, only after that threshold is reached, will such decisions be made. He reminded the Committee that AMA was an initiative of the African Union (AU) formerly known as the OAU, which was founded to fight against colonialism and liberation from colonialism. South Africa was the last major country to get its freedom, thereafter the OAU decided to form the AU to focus on development. Therefore, the AU members who end up ratifying the treaty would determine how this treaty is going to be financed. There is no way it will be retrospective. Once the membership threshold is met, will he AMA take that decision. Until then, it is the AU’s offspring and responsibility. There are various structures such as AU, UN, WHO where formulas already exist, when it comes to choosing how the different countries contribute. Whatever formula is selected, it must be affordable and speak to value for money.

The treaty value cannot be put in money terms now but only the benefits for the country. When you have multilateral and international organisations operating in your country, the privileges and immunities are to ensure that a country's normal exercise of business should not be harmed and disadvantaged, it does not cover criminal activities.

On staffing, all members of participating countries should be eligible to be considered for vacancies, but it cannot be based on any quota but on the qualifications.

Department response
Dr Modisenyane re-emphasised that the annual contribution had not been set yet, hence it was important that South Africa ratify to ensure we provide leadership. Part of the resources will come from other resource mobilisation mechanisms, some of which are the donations from international organisations, government and the private sector. AMA will also provide certain services such as inspections and the proceeds will be part of the resource mobilisation. Pending AMA financial rules by the conference of state parties, for now AMA shall abide by the African Union financial rules and regulations where appropriate.

On the OAU General Convention on Privileges and Immunities, the chief state law advisor has indicated that South Africa is not party to that. Therefore, it means that we will not be able to give effect to this particular provision. If we ratify the AMA, we will put a reservation around article 33 when South Africa submits its instrument of ratification. However, we are not the hosting country of AMA, Rwanda is. When it comes to privileges and immunities, the Rwandan government will provide the courtesy to AMA staff.

SAHPRA response
Dr Boitumelo Semete-Makokotlela, South African Health Products Regulatory Authority(SAHPRA) CEO, reflected on the important matters that she felt were reason South Africa needed to ratify AMA. South Africa was being asked to ratify the treaty because we are acknowledged as a strong regulator and because of our contribution to the African continent. There is also benefit for South Africa when we participate in continental initiatives. She made an example of the equipment funded by the Africa Centre for Disease Control and Prevention (Africa CDE) for the lab that assessed all the COVID-19 vaccines. This highlighted the benefits of countries ratifying such treaties. In addition to manufacturing the vaccines and medical devices, PEPFAR (President’s Emergency Plan for AIDS Relief) and other global institutions like the Global Fund, have indicated they want to start to procure locally manufactured devices, in-vitro diagnostic tests and therapeutics. We are seeing growth in locally manufactured devices including CapeBio SA that we saw during COVID-19. If we ratify the treaty, South Africa would be able to participate in these harmonised mechanisms and make their products available across the continent. So, there is a benefit for us as a regulator, benefit for the industry and the benefit in being able to quickly review products as a regulator. The public will also benefit in that this mechanism will ensure that SAHPRA works a lot more efficiently in these products that AMA will focus on. Several of us regulators do not have adequate capacity and so having this continental mechanism will drive efficiencies in our respective countries.

On equitable participation, each economic region in the continent will be equitably represented. AMA is looking at appointing the board so there is an urgency for South Africa to ratify the treaty because only when you have ratified, can your country participate in the nomination of individuals to serve on the board – considering not only South Africa's regulator strength but also its academic community. The expectation is that these will be open processes and comments on staffing will be considered.

Committee Report on AMA Treaty: adoption
The Chairperson went through the Committee Report recommending the ratification of the AMA Treaty by the NCOP.

The Committee adopted the report.

Committee minutes
The Committee adopted the minutes of 20 June, 5 and 22 September, 31 October 2023.

The meeting was adjourned.