Medicines and Related Substances Amendment Bill

2008

Presented by: Abeda Williams

5 August 2008

Pharmaceutical Industry Association of South Africa

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

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Expected outcome of amended Medicines Act

• Faster approval of clinical trials and registration of medicines

• Increased patient access to generic and new medicines

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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

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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

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Current Proposed

Registration MCC: safety, efficacy; quality

PricingDOH: Single Exit Price,

logistics/dispensing fees

Re-imbursementPrivate: Medical schemes / aids

Public: State Tender Board for tendering

Certification Authority: safety, efficacy;

quality

Registration MoH: public health

PricingDOH: Single Exit Price,

logistics/dispensing fees

Re-imbursementPrivate: Medical schemes / aids

Public: State Tender Board for tendering

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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

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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)

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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

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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

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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

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Countries have separate authority to review

medicine access for national health systemsCOUNTRY REGISTRATION

(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)

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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

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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

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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

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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

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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

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Contact for information

PIASA office: Maureen Kirkman 011 805 5100

Presenter: Abeda Williams082 567 7887