1. Medicines and Related Substances Amendment Bill 2008 Presented by: Abeda Williams 5 August 2008 Pharmaceutical Industry Association of South Africa

2. Abbott Laboratories South Africa (Pty) Ltd Adcock Ingram Healthcare (Pty) Ltd AHN Pharma (Pty) Ltd Alcon Laboratories (Pty) Ltd AstraZeneca Pharmaceuticals (Pty) Ltd Bayer Schering Pharma (Pty) Ltd Boehringer Ingelheim (Pty) Ltd Bristol-Myers Squibb (Pty) Ltd Covidien (Pty) Ltd Galderma Laboratories (Pty) Ltd GlaxoSmithKline South Africa (Pty) Ltd iNova Pharmaceuticals (Pty) Ltd Janssen-Cilag (Pty) Ltd Key Oncologics (Pty) Ltd Merck (Pty) Ltd Novo-Nordisk (Pty) Ltd Schering-Plough (Pty) Ltd Sekunjalo/Bioclones (Pty) Ltd Servier Laboratories SA Pty) Ltd Solvay Pharma (Pty) Ltd Stiefel Laboratories (Pty) Ltd Wyeth South Africa (Pty) Ltd 22 PIASA Members

3. 3 Expected outcome of amended Medicines Act Faster approval of clinical trials and registration of medicines Increased patient access to generic and new medicines

4. 4 We support following changes Establishment of a new Authority Formal inclusion of all health products Authority based on business principles with in-house expertise Code of Practice for all health products

5. 5 Key concerns on Medicines Act Two tiered regulatory system of health products –Safety, efficacy, quality is supported –Concern is ‘public interest’ which may allow political intervention as part of registration Omission of empowering provisions Lack of adequate transitional measures

6. 6 CurrentProposed Registration MCC: safety, efficacy; quality Pricing DOH: Single Exit Price, logistics/dispensing fees Re-imbursement Private: Medical schemes / aids Public: State Tender Board for tendering Certification Authority: safety, efficacy; quality Registration MoH: public health Pricing DOH: Single Exit Price, logistics/dispensing fees Re-imbursement Private: Medical schemes / aids Public: State Tender Board for tendering

7. 7 Why concerned about ‘registration’ controlled by MoH The Authority will not be independent Public health interest should be dealt with separately from registration Economic / financial considerations should be considered by appropriate authority e.g. –DTI’s Industrial policy framework (e.g. NIPF and IPAP) –Treasury controls tender system for public sector access Data for decision making on ‘public interest’ is lacking e.g. national epidemiological data

8. 8 Countries that consider ‘public interest’ Some countries do consider public interest but –Separately from registration process –Reviewed by separate authority (not DOH) –Products may still be sold, even if not reimbursed by the separate authority Belgium: re-imbursement for national health system USA: Public health need based on clinical benefit vs potential risk United Kingdom: re-imbursement for national health system (NICE)

9. 9 Country with similar health system as SA which considers ‘public interest’ Brazil: -Constitution: Health care is a right of all and State obligation -Health system has private and public sector -Medicines controls: Registration; Pricing; Re-imbursement on public health interest Impact of Brazilian medicine review system: -Decline in submission: 2006: 106; 2007: 92; 2008: 14 -Significant decline in approvals: Only 4 approved -Patients have been denied access to new medicines -Citizens seek court interdict to get medicine access

10. 10 Why concerned by other factors of ‘public interest’ MOH should not be responsible for: economic interests in relation to health policies –Cost-effectiveness (economic assessment) can be considered by Pricing Unit of DoH. This can be used as a basis for medical scheme’s decision to re-imburse –Trade and industrial policy issues to be dealt with by Department of Trade and Industry and Treasury access to health care for vulnerable groups –Medicine availability in State sector is controlled by government policy. –Private patients could be denied access to new medicines

11. 11 Why concerned by other factors of public interest (continued) national health policy and goals –Is approval limited to National Essential Drug Lists (EDL) –What about other non EDL generic and new medicines –Will generic and new non EDL medicines be denied approval thereby preventing patient access to medicines the experience of other countries (marketing, distribution and use of the product) –Countries not defined public would be best served by such registration - Ill defined, subjective and non scientific

12. 12 Countries have separate authority to review medicine access for national health systems COUNTRYREGISTRATION (Health Authority) PRICE CONTROL (Economic Authority) RE-IMBURSEMENT (Health Economic authority) Austria√√ Australia√√ (only HE) Belgium√√√ (reference price & HE) France√√√ (only HE) Germany√√ (only reference pricing) Netherlands√N/A√ (reference price & HE) USA√√ (only HE) UK√√√ (only HE)

13. 13 Possible impact of two tiered review Likely to further delay patient access to medicines: –Duplication of submissions and reviews –Additional government resources needed (human and financial) Patient access may be denied irrespective of patient being able to afford medicine Prevention of market access could be deemed anti- competitive Fewer new medicines approved will potentially affect pipeline of future generic products Patient would not benefit from new use of medicines if registration is denied –e.g. new ARV’s used as add-on therapy to existing treatment and later as monotherapy

14. 14 Issues relating to MTT report MTT report does not recommend a two tiered system No estimate of financial cost of two tiered review –Financial aspect of establishing Authority for all health products has been considered Success depends on availability of additional skills and resources –MTT report suggests staff increase from 138 to 482 needed for efficient and timely of clinical trials and medicine registration only Registration timelines likely to be further delayed –Registration to reduce from 3 to 1 year would not be possible with two tiered review even if done as a parallel process

15. 15 Recommendation: Medicines registration Only One - step process for the registration Registration based on current system of safety, quality and efficacy (scientific/clinical decision) – in line with all other regulatory authorities and ICH and not a political, economic or financial decision Public interest to be dealt with in government policy and not be part of medicines registration

16. 16 Question scope of Amendment Bill DG needs to clarify ‘relationship’ with Patent office Assume Brazil system has been considered -Result: 20 % decline in patent approvals Impact for South Africa -Has there been consultation with DTI? -International pharma companies could reconsider local licensing agreements -Could impact the success of Authority -Further delay the registration of medicines and patient access to new medicines

17. 17 PIASA Conclusion / recommendation Support Medicines Amendment Bill provided: There is only one step review of medicines based on safety, efficacy and quality -This will ensure independence of Authority Act has empowering provisions to avoid regulations being ultra vires Adequate transitional measures are clearly defined

18. 18 Empowering provisions Transitional arrangement MTT report has positive recommendations to improve regulatory system Amendment Bill lacks empowering provisions for enabling enforceable regulations to implement MTT recommendations No provision for transitional arrangements Recommendation: Enabling provision in Act for prescribed time frames in regulations Effective confidentiality clause and data protection Provisions for risk-based assessments Enforcement of Code of Marketing Practice (s18c), bonus, rebates (s18a) and sampling (s18b) to eliminate perversities Provision for transitional arrangements

19. 19 Contact for information PIASA office: Maureen Kirkman 011 805 5100 Presenter: Abeda Williams 082 567 7887