STAKEHOLDERS FORUM THE PHARMACY Oral Presentation to the

STAKEHOLDERS FORUM THE PHARMACY Oral Presentation to the Portfolio Committee on Health Public Hearing on Medicines and Related Substances Amendment Bill (B 44 -2008) 6 August 2008 Presenter: Mr Sham Moodley

PSF membership THE PHARMACY STAKEHOLDERS FORUM • 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 Pharmacies – Sparkport Group • Represents approximately 80% of independent pharmacies in SA

THE PHARMACY STAKEHOLDERS FORUM 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

THE PHARMACY STAKEHOLDERS FORUM 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

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

THE PHARMACY STAKEHOLDERS FORUM 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 10 A) 1 RPL = Reference Price List 2 NHA = National Health Act

Conclusion: Dispensing Fee THE PHARMACY STAKEHOLDERS FORUM • 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

THE PHARMACY STAKEHOLDERS FORUM 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 22 G(2)(b) of Act 101 of 1965

THE PHARMACY STAKEHOLDERS FORUM 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.

THE PHARMACY STAKEHOLDERS FORUM 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

THE PHARMACY STAKEHOLDERS FORUM 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

THE PHARMACY STAKEHOLDERS FORUM 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 Mo. H to deny licenses on grounds of availability of existing pharmaceutical services • Medicines Act must be amended to achieve this NDP policy objective

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

THE PHARMACY STAKEHOLDERS FORUM List of Additional Items for Consideration (2) • Medicines for travelers • PCDT services by pharmacists • Logistics fee • Generic substitution for the State • Stock remedies

THE PHARMACY STAKEHOLDERS FORUM Thank You