Medicines & Related Substances Amendment Bill: Protecting the Nation’s Health “The State must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of these rights” Section 27, The Constitution of South Africa, 1996 Doctors Without Borders South Africa

MSF in South Africa MSF projects in South Africa since 1999—largely in response to HIV epidemic. Today, projects include: – HIV/TB project in Khayelitsha, Western Cape. – “Treatment as Prevention” project in Eshowe, Kwa-Zulu Natal. Global HIV & TB Advisory Unit based in Cape Town – Provides training and operational support for MSF projects across movement MSF Southern Africa Association based in Johannesburg: members from 7 countries in the region

Doctors Without Borders South Africa MSF & Medicines Control Work to push access to and development life saving and prolonging medicines, diagnostics and vaccines across the world since Over 40 years in ensuring high quality standards applied to developing and emerging areas. Global network of Pharmacy Scientists working to ensure quality across programs.

Doctors Without Borders South Africa How can this amendment protect the Nation’s Health? Public health should be a cornerstone of the Act Increasing access to treatments saves lives – Fast-tracking registrations of new treatments of public health significance – Harmonization of information with other Stringent Regulatory Authorities – Open and Transparent applications with Agreed Timelines – Explicit provision for affordability as a Section 21 criteria Affordability of treatment increases access Link to Intellectual Property Reform – Challenging patents with detrimental public health impact – An existing model that works: Brazil (ANVISA)

Access: Fast-tracking 15(2)b: Formal provision in the act for the Department of Health to notify the Authority of treatments of high public health significance. – Amendment required: Specific timelines (6 months) with explicit penalties of Authority for non compliance Improved Amendment 2B(2)(a): Liaise with other Stringent Regulatory Authorities (SRA) – Amendment required: Formal mechanism where other SRA findings can be utilised in order to speed up registration Doctors Without Borders South Africa

Fast-tracking to save lives MSF uses linezolid in Khayelitsha, in line with national and international guidelines, to treat complicated cases of DR-TB MSF tried to access cheaper generic version of LZD in 2011 when Pfizer would not drop their price. Pfizer have still not answered Government tender for TB treatment A 6-month supply of Pfizer linezolid costs approximately R123,000 per patient – one drug was eating up 10% of entire MSF Khayelitsha budget Generic company received quality approval from Global Fund and United Kingdom regulatory authority in Still not registered in South Africa, restricting access to 1,000s that need it Doctors Without Borders South Africa

Access: Open & Affordable Section 22: An Open & Transparent Process – Amendment required: Formal provision to require the Authority to make public the date of application submission, name of medicine in question, expected price and current status of application Section 21: Council may authorize sale of unregistered medicine for certain purposes – Amendment required: Extension of provision to formally allow the Department of Health and medical NGOs to obtain Section 21 exemption on the grounds of affordability restricting access to life saving treatments Doctors Without Borders South Africa

Link the Authority to IP Reform 15C: Measures to ensure supply of more affordable medicines Extend 15C(a) to give Authority power to review all new Patent applications – The Brazil Model as a successful example that improved affordability to its Government Doctors Without Borders South Africa

ANVISA in Brazil: Prior Consent Challenges patents with detrimental public health impact Participation of the health sector in the process of examination of pharmaceutical patent applications. ANVISA has established a technical group of experts that understands pharmaceutical innovation Compliance with international rules: – Relates to article 8 of TRIPS: “Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio- economic and technological development.” – Guidelines for the examination of pharmaceutical patents, WHO 2007 Doctors Without Borders South Africa

Summary of Proposed Amendments  Act 15(2)b: Specific timelines of registration (6 months) for priority treatments, with explicit penalties of Authority for non compliance  Act 15C(a): Give Authority power of “prior consent” of all new pharmaceutical Patent applications (The Brazil Model)  Act Section 21: Extension of provision to formally allow the Department of Health and medical NGOs to obtain Section 21 exemption on the grounds of affordability restricting access to life saving treatments  Act Section 22: Formal provision to require the Authority to make public the date of application submission, name of medicine in question, expected price and current status of application  Amendment 2B(2)(a): Formal mechanism where other Stringent Regulatory Authorities’ findings can be utilised in order to speed up registration

Medicines & Related Substances Amendment Bill: Save Lives & Protect the Nation’s Health Integrate Public Health into this Bill “The State must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of these rights” Section 27, The Constitution of South Africa, 1996 Presented by: Andrew Mews & Dr. Amir Shroufi Doctors Without Borders South Africa