Regulatory reforms in South African Pharma – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
NATIONAL HEALTH INSURANCE BILL AND MEDICAL SCHEMES AMENDMENT BILL
On 21 June 2018 the Minister of Health Published the Medical Schemes Amendment Bill and the National Health Insurance (NHI) Bill for comment by the public and interested parties within the respective Industries.
In terms of the current environment in South Africa and the Minister of Health (and the Government) aim to achieve adherence to Section 27(2) of the South African Constitution which require for the State to “take reasonable legislative and other measures, within its available resources to achieve the progressive realisation of the right”.
The right referred to is the Right to access to health care in terms of Section 27(1) (a) which states “Everyone has the right to have access to health care services, including reproductive health care;”
In this regard the National Health Insurance Bill aims to provide mandatory prepayment health care services in the Republic in pursuance of section 27 of the Constitution; to establish a National Health Insurance Fund and to set out its powers, functions and governance structures; to provide a framework for the active purchasing of health care services by the Fund on behalf of users; to create mechanisms for the equitable, effective and efficient utilisation of the resources of the Fund to meet the health needs of users; to preclude or limit undesirable, unethical and unlawful practices in relation to the Fund and its users; and to provide for matters connected herewith.
There is a definite link created between these two Bills, where the Medical Schemes Amendment Bill in Section 17 state that the Registrar of Medical Schemes may, after consultation with the Minister, restrict the benefits offered by medical schemes having regard to the benefit and service coverage under the National Health Insurance Fund – the aim apparently being to eliminate duplicative costs for the same benefit.
Medical Schemes are not abolished by the NHI Bill and in its current draft there is provision for regulation of the relationship between the NHI Fund and medical and/or other private health insurance schemes. However, the crux of the matter is that the NHI Bill clearly state that where any conflicts between these two Bills are present, the NHI Bill and the Constitution shall prevail.
The deadlines on providing comments on these two Bills are three months from the date of publication. Until such time, the current legislative framework in so far it relates to public health care services and medical schemes and its functioning within the private health care sector, remains unchanged.
2. When are they likely to come into force?
These two Bills have only been published on 21 June 2018 and will go back to Parliament for consideration after the three-month period for comments have come to an end.
The publication of the NHI Bill and Medical Schemes Amendment Bill in the Government Gazette for public comment is followed by referral to the relevant committee within Parliament.
It is debated in the relevant committees of Parliament and amended if necessary. If the Bill passes through both the National Assembly and the National Council of Provinces, it goes to the President for assent (where he signs it into law). Once it is signed by the President the Bill becomes an Act of Parliament and a law of South Africa.
In so far this process relates to the two proposed Bills, there is still quite some time which will pass in allowing the full and correct procedure to take its course.
Therefore, a specific date or timeframe within which these two Bills might come into force is undeterminable at this time.