1. Portfolio Committee for Health Medicines and Related Substances Amendment Bill (06/08/08) IMSA represents Research Based Pharmaceutical Companies

2. Actual Products registered 2003-2007 NCEs 20032004200520062007 No Appl 201720199 % 4.6%5.8%2.6%3.4%2.3% Total 85/2428

3. Registration Applications 2003-2007 20032004200520062007 NCEs 1627182122 Generics 508563490801765 Total 104/3731

4. IMSA supports the (Purpose) Medicines and Related Substances Amendment Bill Significant step forward - framework for reform of regulatory system Consultative Processes (ITG, MTT) MTT recommendations very encouraging and would like to see them inform the Bill If passed – with changes, Bill would enable quicker access to medicines* by South African patients However, we have concern that Bill as it stands does not realise full potential offered by this process and the amendment of the Act. *all medicines

5. IMSA KEY INPUTS AND COMMENTS (previous submissions still stand) 1.Two-tiered registration system 2.Lack of/inadequacy of empowering provisions in the Bill to ensure independence, good governance, efficiency for new Authority 3.No specific provision for publication of regulations to enforce timelines for registration 4.Marketing Code – Bill reduces importance of code of ethics on marketing – lacks regulations to enforce pricing regulations (bonusing, rebates and discounts)

6. CONCERNS WITH TWO-TIERED REGISTRATION SYSTEM Medicines registration based on science globally – Current SA Regulatory System conforms – “science” is not in question Concerns for public interest are legitimate, BUT should not create a 2 nd tier to approval process. Concerns for public interest should be independently addressed, “needs” clearly defined and “individual patient’s rights” considered. Access barriers reduced if all products assessed and approved on scientific bases by an efficient & effective authority. Further interventions eg price, epidemiology, economic interest, NHP, access issues, etc - separate process. 1.

7. The approval of Medicines/Products Registration Application for New Product (Companies): Demonstrates product is safe and effective when used correctly and provides quality standards Authority Assesses data against world class standards and registers products End product of Registration Process A product with a set formula, set method of manufacture, package insert on use, guidance on who can prescribe and who sell Health professionals (Drs Pharmacists, nurses, Allied) general retail Patients Public Health interest Remove 2 nd tier assessment

8. Public Interest – Safety, quality & efficacy To an extent Public interest already provided for in the Act: S 16 of Act as proposed to be amended by S11 of Bill provides for Authority in consultation with MoH to deregister a product in public interest S 15(7) provides for 5 year review of all products – ensures scientific integrity Pricing regulations already provide for management of prices Licensing provisions ensure appropriate manufacturing and supply chain systems

9. What could be added value of 2 nd tier assessment Cannot increase access – cannot make more products available Could only serve to decrease access – ultimately affecting availability of generics (NCEs are the pipeline) Could unwittingly exclude potentially valuable products before “in-use” profile of products established Could decrease competition in the market – price consequences Negative incentive to research based companies to do initial registration and introduction of the product This concern is not the same as the issue of the persona and powers – the question is - what is achieved by linking 2 steps

10. Public Interest Beyond Safety, Efficacy and Quality is already there Manage private sector prices (SEP) through pricing regulations and pharmaco-economic evaluations Manage availability of products to public sector via Essential Drug List and tender system Develop specific policy for SA around supply of treatments for burden diseases and emergency situations Important – distinguish between needs for: essential medicines, medicines for burden diseases, general therapeutics MAKE APPROPRIATE POLICY FOR EACH NEED

11. TWO-TIERED REGISTRATION Solution we propose Do not delete S1(3) – existing definition of public interest Delete proposed amendment 15(4)d giving new definition of public interest Remove all references to a two-tiered process Replacement of the word “Certification” with the word “registration” Removal of the word registration where this word is used in the context of the second decision tier based on “public interest

12. CONCERNS WITH PROPOSED SAHPRA STRUCTURE Solution: The nature of the structure is not key determinant but the Act must provide for: –the Authority’s independence –governance principles –one overarching Authority –with separate and accountable divisions for the different products Provide for regulations to introduce MTT recommendations on efficiency 2

13. CONCERNS WITH PROPOSED SAHPRA STRUCTURE S4 of the Bill deletes the empowering provisions for the MCC & provisions for conflict of interest. It does not reciprocate in respect of a new Authority Structure and Governance. Amendment Bill lacks provisions for the introduction of regulations to give effect to principles recommended in the MTT report 2

14. CONCERNS WITH PROPOSED SAHPRA STRUCTURE Proposal: Don’t delete sections – rework them to ensure governance issues addressed according to principles identified. Constitution, scope, decision and policy making powers, Authority levels and delegation of powers Provision to avoid Conflict of interest Alignment - Principles of Administrative Justice Accountability on service delivery with transparency in process Clear guidance on qualifications, skills and performance standards MTT report: pgs 40, 75, 78, 79, 89, 96, 133-135) Replace section deleted on Conflict of Interest. Provide in S35 for regulations to be made

15. CONCERNS WITH REGISTRATION TIMELINES Problem: Bill does not provide for regulations to prescribe registration timelines Solution: Stipulation necessary to turn around current delays & turn system around. There is International precedent to mandate timelines in regulations (EU, Aus,..) Proposal: add to 15(2) “as soon as is stipulated in timelines set by regulations” 3.

16. MARKETING CODE Problem: Currently in law BUT code not published. Bill is proposing that publication of the code is optional (“May publish”) Solution: Publication of the code should be obliged by the legislation Proposal: S16 of the Bill - the change of “Shall” should not be changed to “May” 4

17. MARKETING CODE – amendment to support the intent of the code Problem: The code alone cannot solve the problem of perversities in the “medicines” chain Solution: S18A of the Medicines Act should be supported by Regulations that provide definitions for what perversities are specifically disallowed. Proposal: S14: whilst amending S18A to provide for products, add “as is prescribed and defined from time to time”

18. RECOMMENDATIONS – PROPOSED CHANGES/ADDITIONS TO THE BILL 1.Adjudication of scientific considerations to be separate from addressing “public health interests” 2. Create an adequate framework to ensure the new Authority can achieve what it is intended to achieve, and that patients are well served by it, including providing for necessary regulations 3. Provide for regulations requiring adherence to timelines 4. Ensure that “product” advertising and promotion is governed by an enforceable code of practice. Ensure that perversities are effectively eliminated by provision for regulations to support S18A – fix legal gap

19. Thank you for this opportunity to contribute Discussion…