Procurement of patented and other essential medicines: challenges and opportunities Wilbert Bannenberg, MD MPH Zambia TRIPS workshop 2 Oct 2013

Essential medicines for all Zambians! Zambia National Medicines Policy wants to provide all Zambians with access to a basic package of essential medicines HC kits can supply this for $0.25 per Tx Due to resistance, new medicines are needed against HIV/AIDS, malaria, TB However, these medicines can be expensive as they are protected by patents Can we buy them as cheaper generic? Or produce them in Zambia?

Essential but patented medicines 2 nd and 3 rd line ARVs New TB drugs New synthetic ACTs for malaria Cancer medicines Non-communicable diseases – Diabetes – Cardiovascular diseases – High blood pressure – Stroke Some are not yet on Zambia’s Ess Meds List as they are expensive: catch-22 situation!

Patents make medicines unaffordable! Patents create monopolies and dependencies – Beneficial for R&D companies (in rich countries) – Limited value for Zambia (mainly importing; very few innovations to be patented) – May affect access to medicines and pooled procurement Drug companies in the rich countries make money from patents (and patients!) What can Zambia do about this?

Zambia is member of WTO World Trade Organisation requires members to apply TRIPS – Provides 20 years protection for patents – Zambia will have to provide patent protection in the future Good news: Zambia (being a Least Developed Country) is now exempted from TRIPS until 2021 Bad news: India can no longer make generics for newly patented medicines since 2005 – Who will make the new generics? – No generic alternative: branded products will remain expensive Zambia is discussing new IP legislation – Use the current debate among MCTI, Justice & PACRA to ensure that the maximum of public health flexibilities are built into the new Patents Bill

Zambia IP / Patent law status Patents Act 1958 obsolete – not TRIPS compliant Zambia has an IP policy (final draft 2009) New Patents Bill has been drafted – Good news: has most of the public health flexibilities Zambia is member of ARIPO, so risk of patents being granted unless Zambia actively says “No thank you!” Zambia can benefit from LDC exemption until 2021 Need to discuss in SADC/COMESA who will make the new generics as India can no longer easily make and export generics for products patented > 2005

Is there a valid patent in Zambia? Most medicines on EML are off-patent New medicines are however often patented – ARVs, cancer, cardiovascular, diabetes, antibiotics Is there a patent? (Search at PACRA, ARIPO) If no (valid) patent – no problem If patented, ask patent holder for voluntary licence on reasonable grounds (contract) If refused or no answer, consider – Applying paragraph 7 Doha Declaration (ignore patent) – Issueing compulsory or government use license (+royalty)

Public Health Flexibilities LDC waiver for TRIPS until 2021 – No need to adhere to TRIPS or grant patents – Pharmaceutical waiver until 2016 (may be extended?) No need to allow new/2 nd use patents (TRIPS+) Parallel import Compulsory licenses / government use Research exemption Early Working (Bolar clause) No need to provide data exclusivity (PRA/ZAMRA!) – The lawyers will explain in next presentations!

Make or import medicines? Difficult policy decision! – Government promotes local production – But at same time wants to have them cheap! Generic medicines are being made in Zambia – Even though raw materials need to be imported PRA/ZAMRA inspecting local production for GMP Buying imported generics is often cheaper – Even despite 15% domestic preference

Zambia did try to make ARVs Pharco plant in Medical Stores when GMR was running MSL management (early 2000’s) China was to supply raw materials Govt issued a compulsory license to Pharco But factory not GMP – no WHO prequalification – Products could not be sold to Global Fund recipients – Zambia government could not afford to buy – Generic ARVs were cheaper – So Pharco stopped ARV production plan

Import generics then? MSL and importers buy registered medicines from cheapest, good quality, prequalified source All current ARVs come as generics < India – Even though there are patents in Zambia!? – Patent holders decided to tolerate cheaper, life saving generics after the 2001 South Africa case! – We have been lucky not being sued! Bad news: India can no longer easily make and export generics of products patented >2005 – Which country will make our future generics? – Tomorrow more about local or regional production!

Zambia best uses a strategy to: Fully use the LDC exemption for TRIPS until 2021 – Refuse any new pharmaceutical patents until 2016 – Ignore existing patents (using para 7 of Doha Declaration) – Buy generics rather than originator products Enter only the minimum required of TRIPS in Zambian IP / Patent Laws Maximize the permitted public health “flexibilities” Avoid TRIPS+ measures (bilateral trade agreements) Watch out for “anti-counterfeiting” laws making generics illegal (COMESA is discussing a draft!)

Summary New essential medicines will be patented, and India can no longer help us! ARIPO – Zambia should opt out for patents until 2021 Incorporate and use maximum flexibilities in Law Regional production of new generics in LDC Avoid TRIPS+ Consider Competition Law (SADC policy 2008) Watch out for anti-counterfeiting laws endangering generics

Acknowledgements Based on – Flexibilities paper by Sisule F. Musungu – Concept paper by Wilbert Bannenberg – presentation drafted by Elijah Munyuki – Comments by Aarti Patel, SARPAM Technical Adviser at SADC office, Gaborone Further contact? – Wilbert Bannenberg,

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