1. THE PHARMACY STAKEHOLDERS FORUM Presenter: Mr Sham Moodley 6 August 2008 Oral Presentation to the Portfolio Committee on Health Public Hearing on Medicines and Related Substances Amendment Bill (B44-2008)

2. PSF membership Voluntary association Represents pharmacy associations and independent community pharmacy groups Members –South African Progressive Pharmacy Association (SAPPA) –Pharmaceutical Society of South Africa (PSSA) –United South African Pharmacies (USAP) –Community Pharmacists Sector of the PSSA (CPS) –Alpha Pharm Pharmacies –Sparkport Group Represents approximately 80% of independent pharmacies in SA

3. The Presentation Bill presents an opportunity to address the sections published for comment as well as the legislative gaps that exist SAAPI Main focus of this presentation is therefore: –Dispensing fee –Dispensing Licenses –List of additional technical items PSF refers committee-submission of 18 July 2008

4. Dispensing Fee PSF supports the principle of a transparent pricing system Legal challenge re dispensing fee 2004 Purpose of this section: to provide a proposal on the process relating to the determination of the dispensing fee and how it relates to the Medicines Act

5. PSF Proposal on Section 22G The PSF would like to recommend that the dispensing fee, currently regulated In terms of Section 22G of the Medicines Act, be incorporated into the National Health Act process, for compilation of a National Reference Price List.

6. Motivation for Proposal Currently there are two different mechanisms determining professional fees of healthcare professionals Major differences: –Medicines Act vs. RPL 1 process (NHA 2 ) –Max fee vs. Guideline/Recommended fee –Pricing Committee vs. RPL advisory committee –Courts decide vs. Appeal process (Chapter 10A) 1 RPL = Reference Price List 2 NHA = National Health Act

7. Conclusion: Dispensing Fee Objectives of two systems are congruent Dispensing fee is the only professional fee determined outside of RPL process Constitutional right to be treated equally By determining the dispensing fee in the same manner as for other professionals, all healthcare professionals would be treated fairly and equally

8. Conclusion continued.. Similar economic principles apply in determining professional fees in the healthcare industry. Therefore we believe-duplication of functions between Pricing Committee and RPL Advisory Committee Only legislative change needed to achieve this would be to delete 22G(2)(b) of Act 101 of 1965

9. PSF Proposal on Dispensing Licenses The PSF would like to motivate that an amendment to the Medicines Act includes the requirement that when an authorised prescriber, as defined in the Medicines Act, applies for a license to dispense medicines, that a license will not be issued where there are existing pharmaceutical services.

10. Motivation for Proposal The DOH published regulations – objective: introducing the requirements for issuing and renewal of dispensing licences. This regulation required that the DG should, among other factors, consider the existence of other healthcare providers in the vicinity Con Court – regulations were ultra vires –Nothing in Medicines Act empowers Minister to develop policy to deny licenses NDP – medical practitioners & nurses will NOT dispense except where pharmaceutical services are NOT available Portfolio Committee on Health, Report 1996, supported this NDP policy

11. Motivation for Proposal (2) Where the prescriber also supplies the medicines, the public is denied the internationally accepted principle of separation of these two functions It is the expert function of the Pharmacist to check the appropriateness of medicines prescribed to patients In reference to the above, the DG, in his High Court affidavit referred to: “bad dispensing practices amongst medical practitioners… including collusion for profit…is detrimental to the public interests” Further, pharmacies remain the only dispensing facility inspected regularly by SAPC (2007 DOH Annual Report, p.26) The pharmacists’ right to practice their chosen profession might be limited by the issuing of dispensing licences to healthcare professionals in close proximity to pharmacies, in terms of Section 22 of the Constitution

12. Conclusion – Dispensing Licenses NDP clearly intended to restrict the issuing of licenses and confine it to areas of need Portfolio Committee, 1996, supported this view Current Medicines Act – nothing empowers MoH to deny licenses on grounds of availability of existing pharmaceutical services Medicines Act must be amended to achieve this NDP policy objective

13. List of Additional Items for Consideration Definition of product Dispensing for own patients Bonusing Section 18A & 22G exemptions Schedules 3 & 4 Schedule 6 registers Consistency in words used for “sell” Repeats of specified Schedule 5 Rx

14. List of Additional Items for Consideration (2) Medicines for travelers PCDT services by pharmacists Logistics fee Generic substitution for the State Stock remedies

15. Thank You