Amendment Bill 6 of 2014 Briefing to the Portfolio Committee 26 th November 2014

Outline and Context The presentation outlines comments raised by stakeholders during the recent public hearing to the Medicines Amendment Bill (Bill 6 of 2014) and responses to these comments by the National Department of Health. The stakeholder comments presented relate primarily to those deemed not to require changes to the Bill and the rationale for these is provided. Comments by stakeholders deemed to require changes to the Bill have been presented previously. 1

Appoint Chairman of the Board for 1 year with expertise rotating between medicines, medical devices and IVDs. – Rotation of chairmanship is not in line with global best practice. This task requires appropriate skills and qualifications as a prerequisite [see 2E(1) pg 5 line 15 read together with 2D(4) pg 5 line 7]. Amend the composition of the Board to allow for the appointment of experts (2) in complementary medicines. The experts must hold a professional qualification with the Allied Health Professions Council. – The composition of the Board consists inter alia of members with various expertise in medicine and the Regulations to the Act will further define the skills of members of the Board which will include members with expertise in orthodox, complementary and biological medicines. 2

Delete the definition of “foodstuff” and “cosmetic”. SAHPRA should not have regulatory oversight of foods and cosmetics as this would increase its workload. – Oversight over food and cosmetics in terms of the relevant legislation i.e. Foodstuffs, Cosmetic and Disinfectants Act, 1972 (Act 54 of 1972) [see 1(e) pg 3 line 27 and 1(f) pg 3 line 30, 2B(3), pg 4 line 28] is a requirement. This mandate of SAHPRA is also a policy decision. Amend the Hazardous Substances Act to avoid overlap of requirements on matters governing electro-medical and radiation devices. – The Medicines Act does not intend to regulate electro-medical and radiation devices. SAHPRA Committees should not evaluate cosmetics and foodstuffs. – This is a misunderstanding as this activity will remain with the relevant units dealing with foods and cosmetics [2B(3), pg 4 line 28]. 3

Include timelines for the evaluation and registration of a medicine, medical device and IVD as the life cycle of a medical device is short and lengthy timelines could render a medical device obsolete. – Act 72 of 2008 Section 35(1)(xl iii) makes provision for timeframes for the consideration of an application by the Authority. Also Section 15(2)(b). This will be further addressed in the General Regulations as well as Guidelines that will address operational matters. [2B (1)(b), pg 4 line 8]. Include a definition for “prescribed ethical and professional criteria and defined standards” – This section relates to the evaluation of clinical trial protocols and the conduct of a clinical trial. The Guideline on Good Clinical Practice includes ethical and professional criteria for the conduct of trials. [2B(1)(f), pg 4 line 17]. 4

Propose “Appointment of Chief Executive Officer” as the heading for Section 3 instead. – The heading currently included states “Chief Executive Officer and other staff of the Authority” and is deemed appropriate. Include an abbreviated and expedited registration process with the recognition of decisions taken by other national regulatory authorities. – This should be included in Regulations rather than in the Legislation. Regulation 5 of the General Regulations makes provision for an expedited registration process. Additionally, under “Functions of the Authority” [2B(2)(a)], provision is made to liaise with other national authorities to allow exchange of information. 5

The provision for SAHPRA to liaise with other regulatory authorities must be an imperative and therefore the word “may” should be changed to “must”. – It remains the prerogative of SAHPRA to seek assistance from other national regulatory authorities [see 2B(2)pg 4 line 19]. Transitional arrangements for staff administering the Food Act and the Hazardous Substances Act to move to SAHPRA are not supported by any amendment to the two Acts and therefore no legal framework exists for the transition. – It remains the view of NDOH that SAHPRA will have regulatory oversight over the duties and functions of staff members administering these two Acts. As per the transitional provisions in Section 25 [pg 14, line 50], all employees will be transferred to SAHPRA. 6

Why should the registration of a medicine, medical device or IVD be refused if it is the opinion of SAHPRA that the registration is not in the public interest? – Regard for public interest has been a requirement since the inception of the Medicines Act and is a norm adhered to by most national regulatory authorities. With the drafting of Act 72 of 2008 this section was omitted in error. Bill 6 of 2014 corrects this omission [see 9 (c), pg 7 line 48]. Criteria for medical devices and IVDs are as per the evaluation requirements for a medicine. – Not in agreement as the criteria for evaluation of medical devices and IVDs will be addressed in the relevant Guidelines. 7

Separate Registrars should be appointed to deal with medicines, medical devices and IVDs, cosmetics and foodstuffs. – The operational structure of SAHPRA is outlined in the SAHPRA Business Plan which makes provision for the heads of these different Units to report to the CEO. Include a definition for “Registrar” and “Chief Executive Officer”. – The responsibilities of the Chief Executive Officer are listed in Section 3 [3(4), pg 6 line 35-45]. The role of the Registrar is obsolete. 8

The composition of the SAHPRA Board and the different Committees should be identified. There is potential risk that non technical members on the Board may out vote technical members. – The composition of the Board is already defined in legislation [2C(2), pg 4 line ] and the skills required will be further defined in the Regulations. The Board will identify as many Committees as deemed necessary for its work. This also allows the Board the prerogative to increase the number of Committees depending on the expertise needed [see Section 22H, pg6 line 19]. Amend Section 22 to require SAHPRA to publish on receipt of an application for registration the name of the medicine, expected price, and date of submission. – Section 22 is not part of Bill 6 of 2014, however the functions of registration and pricing are separated in the Medicines Act. 9

Amend Section 21 to allow the Department of Health and a NGO to apply for the use of an unregistered medicine solely on price. – Section 21 is not part of Bill 6 of 2014, however the mandate of the Authority is to protect patients against the use of substandard medicines by ensuring that medicines comply with standards for safety, quality and efficacy. Price cannot be considered as the sole reason to authorize the use of an unregistered medicine if information relating to safety, quality and efficacy is not available. Amend Section 15C(a) of the principle Act, to require SAHPRA to review and examine all new pharmaceutical patents. – Section 15C(a) not part of Bill 6 of 2014, however the mandate of the Medicines Act is to protect patients against the use of substandard medicines. Review of pharmaceutical patents are not part of the mandate of the Act. 10

Expand mechanisms to enable decisions of another stringent national medicines regulatory authority to be utilised. – Section 2B(2)(a) [pg 4, line 20] that deals with “Functions of the Authority” also addresses the recognition of other national regulatory authorities. This implies that SAHPRA will define cooperative mechanisms and operational actions in appropriate guidelines. Include a definition for “IVD”. – A definition for IVD has been included under Act 72 of Include a definition for “Borderline Medical Devices” to prevent the erroneous classification of a medical device as a medicine. – Definition for “Borderline Medical Device” will be included in the Guidelines on medical devices as the intention of a guideline is to clarify so called “borderline” matters. 11

SAHPRA should not re-assess the registration of a medicine, medical device or IVD. – A number of national regulatory authorities have included the requirement to re-assess the registration of products with the view to ensure that the information on the product remains current and that the product continues to meet acceptable standards of safety, quality and efficacy in the marketplace [2B(1)(c), pg 4, line 10]. Note that “pre-market clinical performance studies”, and not clinical trials, are performed for unregistered IVDs. – The Guidelines on IVDs will clarify the reference to a clinical trial in the event of an IVD as a “pre-market clinical performance studies for an unregistered IVD” [2b(1)(f), pg 4, line

Section 35 must separate requirements for medicines from medical devices and IVDs as not all sections are applicable to medical devices and IVDs. – Not in agreement to separate the requirements for medicines, medical devices and IVDs. It is current practice that enabling Regulations applicable to these products are promulgated as per the requirements of Section 35. Separate Regulations for medicines as well as for medical devices and IVDs are available. Require transitional arrangements for the registration of medical devices and IVDs as well as foodstuffs and cosmetics in the legislation. – Transitional arrangements for registration or oversight of these products should be dealt with in Regulations rather than in the Legislation as is the current practice. Previous experience with the call-up of medicines for registration, required that this be handled through Government Gazette notices in a staggered approach while continuing to allow existing products on the market (grandfather products). In addition, it is not the intention of SAHPRA to register foodstuffs and cosmetics. 13

Include a definition for “family of medical devices”. – Not in agreement to include the definition in the main Act but rather in the General Regulations addressing Medical Devices. Delete reference to the control of medical devices when it contains a Scheduled Substance as per Section 22A. – Many combination medical devices consisting of a device that incorporates a pharmaceutical product are already registered e.g., an estrogen implant which contains a Schedule 4 substance as per the primary use of the combination device [13 (a) pg 8 line 40]. 14

Section 22H should be amended to allow for keeping of consignment stock, importation by different importers, and for any importer to directly distribute medical devices and IVDs. Often more than one importer will import the same medical device or IVD. – All importers are required to be licensed by SAHPRA. The keeping of stock and distribution of medical devices and IVDs by a wholesaler is addressed in the Guideline documents on Wholesaling and Distribution [16(a), pg 9 line 35]. Amend Section 22H(1)(b) to allow for the export of medicines and medical devices or IVDs as the current inscription does not allow exports. – Not in agreement as the current inscription does not prohibit export by Wholesalers provided that an export license in terms of Section 22C(1)(b) has been obtained [15, (1)(b), pg 9 line 17]. 15

Clarify under which circumstances medicines and medical devices or IVDs may be returned to the Wholesaler. – Not in agreement to include these requirements in Legislation but rather in relevant Guidelines. An abbreviated registration process, recognition of registration by other national regulatory authorities and listing of medical devices according to classification risks be included in the main Act. – The requirements for Fast-Track registration of medical devices and IVDs are addressed in Regulations and the corresponding Guidelines. In addition, Section 2B(2)(a) [pg 4, line 20] which deals with “Functions of the Authority” addresses the recognition of registration by other national regulatory authorities. 16

Proposed that the concept of remanufacturing of single-use medical devices to allow re-use be addressed in the Bill which will lead to cost reduction and environmental benefits. – Not in agreement to include in this in the main Act. Requirements for single-use medical devices and their re-use are addressed in the proposed General Regulations on Medical Devices and IVDs as well as in the corresponding Guidelines. Delete the control of Scheduled substances from various sections of the proposed Bill. – Not in agreement. “Scheduled substances” form the basis of the Medicines Act and includes medicines as per the definition for “scheduled substances”. 17

Reference to control Medical Devices and IVDs containing Scheduled substances in terms of Section 22A and Section 18 be deleted. – Not in agreement. Section 18 deals with the requirements on labelling and advertising of scheduled substances. Section 22A deals with who may sell scheduled substances, to whom, and under which circumstances. Delete reference to “Scheduled substances” in the definition of an advertisement. – Not in agreement. The definition of advertisement has always contained reference to “scheduled substances”. Act 72 of 2008 replaced the wording “medicine and Scheduled substances” with “product”. With Bill 6 of 2014 the legislation reverts back to the original inscription [1(a), pg 2 line 11]. 18

Include a sub-section under Section 18C (“Marketing of Medicines”) stating that advertising of medicines forms an integral component of marketing of medicines. – This section does not form part of the Bill 6 of In addition it is the understanding that advertising of medicines includes marketing. In terms of Section 18C, a Marketing Code is available that deals with various marketing practices. Include the definition of “Advertising Standard Authority” as the current MCC approves the ASA Code of Advertising practices. – Not in agreement. The MCC is only a stakeholder that submits comments to the ASA on its ASA Code of Advertising practices. Include a definition for “Biosimilars” in the Act as these products are regarded as so called interchangeable “generic” biological medicines. – Not in agreement. This definition should be dealt with in Regulations and/or Guidelines. In addition, the definition of a biological medicine will be included in the General Regulation. 19

Include various new definitions in the legislation i.e. definition for “cosmeceuticals”, “functional foods”, “nutritional supplements” and “health supplements”. – Not in agreement. The Medicines Act deals with the regulatory oversight of medicines. The Foodstuffs, Cosmetic and Disinfectant Act deals with the regulatory oversight of foods. It is not acceptable to introduce a vague definition in legislation. These concepts may be included in Guidelines to clarify any misunderstanding. Amend the definition of a “medicinal claim” and that of “medicine”. – Not in agreement. The current definition of a medicinal claim and that of a medicine has not been considered to have gaps and is in line with international practice. The proposed amendment to the definitions may cause uncertainty in interpretation. 20

Amend Section 20 which deals with false and misleading advertisements to allow better drafting. – Not in agreement. Current drafting does not allow misinterpretation. Amendment not included in Bill 6 of Subject veterinary medicines to the regulatory requirements of the Pricing Committee. – Section 22G is not part of the Bill 6. It is current NDOH policy not to subject veterinary medicines to price controls. 21