1 / 13

IPASA presentation to Portfolio Committee on Health

IPASA's presentation to the Portfolio Committee on Health regarding key concerns on Bill 6, governance structure, resources, and transitioning measures for the pharmaceutical industry in South Africa.

cmcalexander
Download Presentation

IPASA presentation to Portfolio Committee on Health

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related