1. Options for national or regional production or procurement Wilbert Bannenberg SARPAM

2. Make or buy? Botswana is a small market CMS and importers buy from SADC, India, etc Pricing level? Benchmark = MSH price guide Not all essential medicines are registered! Local production can play a role, but needs to compete with imported medicines Raw materials (API, 80% of value) still need to be imported Generics mostly off-patent; new ARVs patented

3. Basic needs for production Political will Business plan Investment (economic feasibility study) Market (competitors, importers?) Suitable manufacturing site (GMP!) Clean water, air (filters), power (generator) Raw materials, packaging materials Skilled production staff (Pharmacy school?) Drug Regulatory Authority Consumers / buyers

4. TRIPS is only one of the barriers Local legislation / licenses Investment capital Infrastructure Skilled staff Market Cost-effectiveness - make or buy? Feasibility study needed!

5. Is there a patent? Most medicines on EML are off-patent – Chicken or egg situation! New medicines are however often patented – ARVs, cancer, cardiovascular, diabetes, antibiotics – Botswana subject to TRIPS – not an LDC! Is there a patent? (IP office, ARIPO?) If no (valid) patent – no problem If patented, ask patent holder for voluntary licence on reasonable grounds (contract) If refused, consider compulsory or government use license (+royalty) Example: Mozambique (no patents) with Brazil TT

6. Production using voluntary license Contract needed with patent holder Transfer of technology? Quality requirements (inspection by originator!) Registration dossier support? Generic equivalent: bio-equivalence studies! Negotiate terms, compensation, export allowed? Examples: GSK/Aspen Pharmacare South Africa; Gilead’s tenofovir from India

7. Production under Compulsory license Terms of compulsory license? No support from originator! (royalty 1-5%) Own development of dosage form Own development registration dossier Bio-equivalence studies Drug Regulatory Approval TRIPS: predominantly domestic market – Maximum 49% exports Example: Varichem Zimbabwe (ARVs)

8. Export using August 30 procedure Theoretical possibility – Request from other country needed – WTO notification and permission – One batch only; no storage – Each export needs special WTO permission Apotex Canada to Rwanda: only example in 7 years (“once but never again”) Very unlikely that Botswana could do this better than Canada, EU, India etc, which found this not economically feasible

9. Regional production SADC has majority LDCs – seen as one “country” under TRIPS art 31bis LDCs exempted from TRIPS obligations – No problem with patents or export – 2016 extension debate in WTO Mozambique, Tanzania, Zambia etc can produce Botswana can import using government use or compulsory license

10. Regional production SADC member states need to ratify 31bis Need regional strategic agreement on – Who makes what? – Investment – Market – Technical support – Quality / drug registration harmonised EAC products (Cipla Kampala factory) can reach Botswana through Tanzania

11. Alternative: better procurement ABC analysis of CMS purchases – Benchmark against MSH price indicator – Regional exchange of information on prices, quantities, quality, supplier performance Drug regulatory harmonization – Motivate good generic suppliers to register in B Pro-active search for missing essential medicines

12. So, now what? Current procurement prices should still be lowered (more sources, intelligence, regional PP) Get all essential medicines registered! Local production is possible, but not an easy or fast solution for Botswana (feasibility study!) Regional production and import are probably more cost-effective options in short-term Most important TRIPS flexibilities are available in Botswana IP law for local production or import from regional production