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IPASA presentation to Portfolio Committee on Health

IPASA presentation to Portfolio Committee on Health. 31 October 2014. Abeda Williams. Introduction to IPASA General comments on Bill 6 Key concerns on Bill 6 Structure and Governance Systems and Processes Resources Transitioning measures Enabling Regulations

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IPASA presentation to Portfolio Committee on Health

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  1. IPASA presentation to Portfolio Committee on Health 31 October 2014 Abeda Williams

  2. Introduction to IPASA General comments on Bill 6 Key concerns on Bill 6 Structure and Governance Systems and Processes Resources Transitioning measures Enabling Regulations Additions for consideration Summary AGENDA 1

  3. Pharmaceutical Industry Trade association (Innovative Pharmaceutical Association of South Africa) Role and Goals patient-focused healthcare system with universal access to quality care; Environment conducive to investment, continued development and sustainability of the pharmaceutical industry; Respect for and protection of intellectual property rights; Ethical conduct and practices; and Adherence to the Code of Marketing Practice. IPASA 2

  4. IPASA member companies (25)

  5. General comments on Bill 6/Act 72 IPASA supports: • basic principles of Act 72 and Bill 6 • establishment of SAHPRA Noted: • Several comments previously made by industry have been included in Bill 6 Presentation will focus on key concerns and general points for consideration 4

  6. Structure and Governance • Accountability(S.2(b) and (c) & 2A to I) • Organs of State like SAHPRA should report to Parliament on performance and MoH for oversight • Roles and responsibility of Board (section entitled “Functions of the Board” required) • Need to be defined e.g. responsible for technical or advisory oversight of committee 3. Expanded scope of SAHPRA(S.2 (b) • Inclusion of foodstuffs, devices etc., need clear functional responsibilities for each type of product 4. Advisor / technical committee ((S.4 (c)) • Mandate needs to be defined 5

  7. Processes and systems • Systems and processes need to be improved to allow SAHPRA to be efficient • Systems, processes need to be reviewed and changed • Implementation of Risk Based Assessment • Expand s(2)(b)(2) – must (not “may”) liaising with other Regulatory authorities and institutions to streamline processes • Quality screening of all submissions and rejection of inferior submissions • Separation of product reviews to benefit from specialised skills i.e. generics, new chemical entities, devices, etc 6

  8. Resources • Regulatory Science Institute is welcomed but it will take a few years before adequately skilled people are available to SAHPRA, hence • Short Term • Need to expedite clearing of the backlog by: • building capacity of existing staff • improving processes • Risk based assessments • Long Term • Resource SAHPRA with competent and dedicated staff 7

  9. Transitional measures Expanded scope (S. 2B(3))(devices, foodstuffs) • Medicines currently under review by MCC – • clarity needed on how process will be managed as well as transition into new structure • Diverse products to be “registered” • Products need: • different regulatory pathways • defined call up process • Grandfathering for SAHPRA to manage process in accordance to its resources • Question: how will products “on the market” that are not registered be managed? • Resourcing and Contingency plans Avoid transferring the backlog and creating additional backlogs 8

  10. Enabling Regulations • Parallel process of consultation with industry prior to enactment of regulations and implementation of guidelines is required for effective implementation of the amended Medicines and Related Substances Act • Provisions made for enabling regulations to address concerns raised • Regulations defining timeframes and fee for services(S.35) • Regulations relating to governance, process, • Regulations relating to Functions of Authority 9

  11. Additional comments • Overview of legislation is needed to avoid any conflicts / overlaps to allow structures to execute duties within an appropriate legal framework • e.g. Foodstuffs Act, Hazardous Substances Act, National Health Act, etc.) • IPASA comments included Sections that needs clarity and minor technical changes e.g. • Section 14 (a) (b) • Section 22 (h) • Note: distribution chain differs depending on whether it is a medicine, medical device or IVD) 10

  12. IPASA support Act 72 and the Bill of 2008 and Bill 6 of 2014 Request that Parliament Portfolio Committee on Health takes into consideration comments and proposal A process of consultation with industry is needed to facilitate a seamless transition into the new SAPHRA structure and new process It is critical to have a comprehensive business plan to guide the transition into the new structure. Summary 11

  13. Contact: CEO of IPASA - Dr Konji Sebati Tel: (011) 781 3256

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