1. Presentation to the Honourable Portfolio Committee on Health Amendments to the National Health Act Bill [B24 of 2011]

2. Who is PIASA Pharmaceutical Industry Association of South Africa – Longest established trade association in South Africa representing pharmaceutical companies – 18 multinational and local companies operating in South Africa – Supply more than 25% of medicines into the public and private sectors in SA – Public sector (based on survey results): – 15 companies currently supply a total of 158 products, most of which are used for the treatment of NCDs ( 137 products) equivalent to 87%.

3. PIASA members – responsive to health needs of South Africa 15 companies EDL = Essential Drugs List Disease areas: Non-communicable diseases HIV/TB Maternal and Child Health Ref: PIASA NHI Submission

4. PIASA position PIASA fully supports the implementation of a structure and standards aimed at ensuring quality of care, which will ultimately protect patients whilst optimising compliance to standards by all stakeholders

5. National Core Standards An independent National Inspectorate (OHSC) will carry out inspections to determine degree of compliance and issue public report on their findings and a certificate of compliance. BUT – Inspection and enforcement mechanisms already exist for medicines, therefore there may be areas of overlap between OHSC and other regulators

6. Medicines are well regulated – quality, safety and efficacy controls across the value chain Medicine Development API quality controls IPI quality controls GMP controls /inspections Stability Clinical development GCP controlsMCC approvalEthics approval Pharmacovigila nce Audits Medicine Registration & price MCC review & approval Safety. Quality & Efficacy Package Insert/PIL Approved uses Marketing Authorisation Manufacturing GMP controls Batch Quality Controls Marketing For approved uses Marketing Code DTC controlsPrice controls Distribution Batch quality controls GDP Storage Controls Medicine Recalls Product complaints Dispensing & Usage OTC Patient Choice HCP prescription Mandatory Substitution ReimbursementCounseling Pharmacovigila nce Product complaints Destruction Destruction guidelines Systems and skills already exist to monitor compliance across the value chain managed by other regulatory bodies

7. EXAMPLES OF AREAS OF OVERLAP

8. Domain 1: Patient Rights 1.2. Access to information for patients – 1.2.1 Patients are given the information they need regarding their treatment, their care after discharge and their participation in research where relevant Current measures Medicines Act: – Provision for package inserts for medicines in regulations – Package inserts approved by MCC – GCP requires informed consent from clinical trial participants – Clinical trial protocol approvals by MCC and ethics committees Consumer Protection Act, ethical rules, NHA Chapter 2 Core Standards

9. Domain 2: Patient safety, clinical governance and clinical care Core Standards 2.5 Adverse events – Adverse events or patient safety incidents are promptly identified and managed to minimise patient harm and suffering Adverse events policy and procedure – Adverse events are routinely analysed and managed to prevent recurrence MCC Guideline Requires reporting of adverse reactions related to medicines by healthcare professionals and manufacturers of medicines within specific timeframes in a specified format

10. Destruction of medicines MCC Guidelines Specific requirements for medicine destruction, including qualified pharmacists to be present to sign off destruction Bill Environmental Health Inspectors also under OHSC – Overlap with MCC and SAPC inspectors

11. Independence and accountability 79A(1) CEO appointed by Minister 79A(4) CEO may be removed by Minister 79D(1)(b) & 79D(3)… OHSC reports to Parliament via MoH’s office 81(A)(9) &(10) Ombud recommendations via CEO or MoH PIASA recommends direct accountability of the OHSC to parliament and real independence for the Ombud to make decisions

12. Clause 78 vs. 82 vs. 89 – Monitoring vs. enforcement 78 - Objects of Office – To monitor compliance to norms and standards – Consideration, investigation and disposal of complaints However, functions outlined in the Bill extend beyond monitoring to include non-certification and fines 82A – Non-compliance with prescribed norms and standards – (4)(a)&(b) fines and referral to NPA 89(2) – Offences and penalties – Liable on conviction to a fine or to imprisonment Including provisions for norms and standards Inspections and enforcement Currently for medicines: provisions for norms and standards, monitoring compliance, inspections and enforcement exist under the Medicines Act and the Pharmacy Act for ALL in the supply chain

13. Clause 79(2)(e) & 79B – Delegation, Co- operation and Harmonisation 79(2)(e) Negotiate co-operative agreements with any regulatory authority in order to – (i) co-ordinate and harmonise the exercise of jurisdiction over health norms and standards 79B(3) CEO may enter into contracts or appoint expert or technical committees to assist the Office.. Norms and standards exist for medicines that are enforced by other regulators, MCC & SAPC – Harmonisation provision is not sufficient in detail to deal with known overlaps with medicine regulatory system – creates legal uncertainty – Existing and known overlapping jurisdictions on standard-setting and inspections are not dealt with in the Bill – If not dealt with, it will create confusion in industry from a compliance perspective and duplicate functions that already exist PIASA proposes that, standard-setting, compliance and enforcement within powers of MCC and Pharmacy Council be excluded, and, where necessary that these bodies are called upon to evaluate suspected non-compliance with such standards

14. Clause 79 (1)(b) & 79 (1)(f) – Inspections and QA 79(1)(b) inspect and certify health establishments as compliant or non-compliant with prescribed norms and standards or where appropriate and necessary withdraw such certification 79(1)(f) Recommend quality assurance and management systems for the national health system to the Minister for approval Medicines are registered on the basis of safety, quality and efficacy by the MCC, including – provisions for inspections to ensure the quality of medicines through good manufacturing practice – provisions for medicine recalls where quality issues are identified SAPC & MCC responsible for inspection of pharmacies, including manufacturing pharmacies Specialised skills are required for monitoring and inspection for compliance to standards with medicines standards; inspectors undergo specialised training to conduct inspections

15. Conclusion Medicine value chain is complex and well regulated Quality, safety and efficacy controls exist across the medicine value chain Specialised expert skills as well intimate knowledge of operational processes are required for inspection purposes – Base qualifications not adequate – Internationally these requirements have become areas of specialisation It is recommended that areas of overlap between the OHSC and MCC and SAPC be carefully reviewed in order to avoid duplication and facilitate adherence to norms and standards to ensure and maintain quality of medicines to protect patients

16. For further information, please contact: Kirti Narsai Head: Scientific and Regulatory Affairs Tel: 011-805-5100 Email: kirti@piasa.co.zakirti@piasa.co.za