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

Additions for consideration Summary

AGENDA

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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

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IPASA member companies (25)

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

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Structure and Governance

1. Accountability (S.2 (b) and (c) & 2A to I)

Organs of State like SAHPRA should report to Parliament on

performance and MoH for oversight

2. 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

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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

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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:

obuilding capacity of existing staffo improving processesoRisk based assessments

Long Term‐ Resource SAHPRA with competent and

dedicated staff

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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:o different regulatory pathwayso 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 plansAvoid transferring the backlog and creating additional backlogs

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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

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Additional comments

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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

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Contact:

CEO of IPASA - Dr Konji Sebati

Tel: (011) 781 3256