Thank you, Chairperson. I will speak in English. As members will note, the objects of the Medicines and Related Substances Amendment Bill are to amend the Medicines and Related Substances Act of 1965.
This will provide for the establishment of the SA Health Products Regulatory Authority; the certification and registration of products, which include medicines, certain foodstuffs and cosmetics; control of scheduled substances; the certification and registration of medical devices; and the abolition of the Medicines Control Council and the pricing committee, and matters related thereto.
The principal Act of 1965 did not provide for access to health care services for all South Africans. Beyikhetha abamhlophe kuphela. [It selected the whites only.] And this Bill seeks to ensure that access to affordable and quality health care is achieved for all South Africans, including us, the black people.
The Act of 1997 sought to control the manufacture, sales and distribution of medicines, with the Minister of Health regulating the supply of more affordable medicines in certain cases, and to protect the public interest. The Act of 2002 as it was introduced was also assisting in the regulation, marketing, compounding and dispensing of medicines.
This Bill aims to ensure that the Medicines Control Council functions effectively, efficiently and broadens its mandate to cover approval of the complementary and African traditional medicines, medical devices, cosmetics and food products with medical claims.
Now, section 1 of this Bill seeks to amend and provide for the definitions of words, such as the substitution of certain words like "medicines", which is now substituted with the word "products". [Interjections.]
Order hon Van der Merwe and hon Adams! Continue, hon member.
Chairperson, they are wasting my time. When are they going to bring back my time?
Section 2 makes it possible for the Medicines Control Council to function as an agency that has a chief executive officer, who will be accountable to the Minister of Health. The SA Health Products Regulatory Authority will thereby be introduced. This will ensure that the agency is able to retain its revenue, recruit and retain the critical human resource capacity needed for it to fulfil its functions. When opinions of experts are required a panel of external experts will be called.
Section 3 of the amending Bill provides for the appointment of the CEO and the other staff. The agency, as it is referred to in the draft Bill of 2008, will have specific timelines within which it will register health products and approve clinical trials. Furthermore, it is proposed that it will also be able to register products within 12 months, generics within six months, with clinical trials within a month to two months.
Sections 4 to 9 and section 12 of the principal Act are actually repealed. Section 13 of the principal Act refers to the registration of certain products where the CEO is required to record the certification of products by the authority and registration by the Minister.
Clause 15 provides that after the authority has issued a certificate in respect of a product the CEO shall in writing notify the applicant of that fact and submit the application to the Minister of Health for a decision and the registration of the product.
Clause 16(4)(c) provides that prior to registering the product, the Minister of Health needs to take into consideration the following in relation to the state: public health interests, the economic interest in relation to health policies, the strategic interest in relation to health policies, the need and desirability of such products and whether the public in general would be best served by that registration.
In conclusion, the vision and the mission of the department, as it is stipulated by the manifesto of the ANC, is that the department is an accessible, caring and high-quality health care system. It will improve the health status of society through the prevention of illnesses and promote healthy lifestyles and consistently improve the health care delivery system by focusing on access, equity, efficiency, quality and sustainability.
Its priority is also to contribute towards human dignity by improving quality health care. These qualities are enshrined within many policies of the ANC that seek to make sure that members live a healthy lifestyle.
Chairperson, I am sure that with these amendments and the establishment of the agency, regulation and the registration of African traditional medicines we will then see most of our members being able to use African medicines.
It is well-known that the majority of members use traditional healers and they go to them. It is not a shame to go to a traditional healer when the majority of members actually buy Chinese herbal tea and Chinese medicines. We want to encourage them ...
... ukuthi leya khemisi lena elaphaya ecommissioner inkunzi yenyanga noma ... [... that that traditional medicine pharmacy on Commissioner street called Inkunzi Yenyanga or ...]
... you know them, they are called "Amakhemisi Abantu", don't be ashamed to walk into that pharmacy and purchase your medicine. Over and above that, as indicated in the legislation, if you also consult a traditional healer ...
...sengisho zona izinyanga kanye nezangoma. [... I mean traditional healers and izangoma ...]
... you will be able to get a medical certificate and can also claim from your medical aid for ... ...ukuthi uyile wayophalaza, wachatha laphaya esangomeni sakho. Ngiyabonga Sihlalo. [... having gone to your traditional healer to do self-induced vomiting or for having gone to a sangoma to administer an enema. Thank you, Chairperson.]
Debate concluded.
Bill, subject to proposed amendments, agreed to in accordance with section 75 of the Constitution.