1. Latest in Health Law…. SAPRAA June 2008

2. Key pieces of legislation Health Charter & BB BEE Medicines & Related Substance Act, regulations & Code Medical Schemes Act & regulations Children’s Act National Health Act Health Professions Act & ethics Pharmacy Act & ethics

3. THE MEDICINES ACT (In Parliament June/July 2008)

4. The latest… MTT Report… Amendments to the Act to include ‘all products’ (devices, complementary meds, cosmetic & food products which make medicinal claims etc) New Authority (structure & decision- making powers not clear) CEO & staff….

5. The latest… Two-phases process of product registration: –CERTIFICATION (Safety, quality, efficacy) –REGISTRATION

6. Valid for 5 years Devices etc will be called up… Labelling, sampling of device on registration Bonusing Sampling Codes of Marketing Practice The latest…

7. Why clear empowering provisions? 1.No future regulation is being challenged for being ultra vires the Act 2.Future Authorities know exactly what types of regulations, policy and guidelines will be / are required for effective regulation 3.Regulations will to be relevant, applicable and enforceable to the specific subject matter at hand 4.Prevents challenges on vagueness

8. NATIONAL HEALTH ACT New Draft Chapter!! (In Parliament: July onwards)

9. New draft chapter: price negotiations To all contexts (not only PMBs) “prices” mean tariffs, fees or any form of reimbursement for health services rendered, procedures performed and consumable and disposable items utilised by health establishments, health care providers or health workers.

10. Objectives… negotiate collectively on prices; and bargain individually on prices; and ensures transparency and fairness in the determination of prices.

11. The Facilitator… Appointed after nominations – MoH + Assistant Facilitators “Facilitate” negotiations & publish: –Info –Fair and transparent May be called in - bargaining –May request a part for info if requested – other – collective bargaining Refer to Arbitrator if no agreement

12. The Process RPL is published 60 days: MoH invites schemes, providers and hospitals to negotiate May … –“collectively” if associations, and –bargain “individually” May conduct it separately according to field of interest(?) MUST use RPL as reference

13. The Process For PMBs: –Negotiated prices become maximum –“Parties” may NOT change above maximum (Reg 8? No more DSPs???) –IF ARBITRATOR - MUST ALSO CHARGE THIS TO NON-MEDICAL SCHEME MEMBERS!!! (i.e. no private charges / private contractual agreement on expertise, quality, value) For non-PMBs – also use RPL!

14. Disputes & Liability, Exemptions Previous Tribunal & Inspectors (as in April- Draft) no longer in the Bill Now: arbitration Not liable for “in good faith” (rest of admin justice?) Medicines excluded (but devices???)

15. New RPL provision… “(v) the processes of determination and publication by the Director-General of one or more reference price lists for services rendered, procedures performed, and consumable and disposable items utilised by categories of health establishments, health care providers or health workers in the private health sector which may be used- (i) by a medical scheme as a reference to determine its own benefits; and (ii) by health establishments, health care providers or health workers in the private health sector as a reference to determine their own fees, [deleted: but which are not mandatory;] and…

16. MEDICAL SCHEMES (PMB Review now happening…)

17. The latest… PMB Review (impact and input from providers?): –Gaps? –Expansion –Affordability? Amendments – June 2008: –Risk Equalisation Fund (REF) –Trustee responsibilities –Low-income products –Basic benefits + supplementary benefits Where does National Health Insurance fit? (and the previous “plan” – May 2002 DoH)

18. elsabe@benguelahealth.com THANK YOU!!!