Download Options for national or regional production

Options for national/regional
production of generic medicines
Wilbert Bannenberg, MD MPH
[email protected]
Zambia TRIPS workshop 3 Oct 2013
Make or buy?
• Difficult policy decision!
– Government promotes local production
– But at the same time wants to have them cheap!
• Medicines are being made in Zambia
– Even though raw materials need to be imported
• Buying imported generics is often cheaper
– Government allows 15% domestic preference
• Both have to be good quality (PRA assessed)
• Are all locally produced medicines all essential?
Barriers for local production
• Zambia is a small market
– needs export for economies of scale
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Unpredictable all or nothing tenders
Infrastructure (power, water)
Skilled staff
Investments, sustainable market, tech transfer
Cost-effectiveness - make or buy?
There are niches for local production!
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Local packaging / labelling / embossing
Special dosage forms (HCT 12.5mg, paediatrics)
Heavy products (water based)
Special climatic zone 4 packaging
Neglected essential medicines
Urgent supplies
Popular “nice to have” products (cosmetics?)
New generics that India can no longer make!
– Joint venture with an Indian company?
What can government do?
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Drug Policy supports national production
Domestic preference 15%
Stable infrastructure (energy, water, skills)
Capital, soft loans, duty free zones, no VAT/tax
Predictable market (better qualification)
Longer term commitments/ split tenders
Strict quality/GMP assessment, harmonisation
Regional Pharmaceutical Collaboration
– SAGMA, SARPAM, SADC
• Export subsidies
Is there a patent?
• Most medicines on EML are off-patent
• New medicines are however often patented
– ARVs, cancer, cardiovascular, diabetes, antibiotics
• Is there a patent? (PACRA, ARIPO?)
• If no (valid) patent – no problem
• If patented, ask patent holder for voluntary licence on
reasonable grounds (contract)
• If refused, consider
– Applying paragraph 7 Doha Declaration (ignore patent)
– Issueing compulsory or government use license (+royalty)
Production under voluntary license
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Contract needed with patent holder
Better chances for 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
Production under Compulsory license
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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
– Zambia exempted as LDC
– SADC can apply art 31bis for regional circulation
Regional production
• SADC has majority LDCs – seen as one “country”
under TRIPS art 31bis (same as EAC, COMESA)
• LDCs exempted from TRIPS obligations until 2021
– No problem with patents or export (para 7 Doha)
• Mozambique, Tanzania, Malawi can also produce
• Zimbabwe and Uganda have WHO prequalified
manufacturing plants
– Will Zambia plants pass WHO inspection?
• Insecurity after 2021?
– Zambia can import using government use or compulsory
license
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 Zambia through Tanzania
Summary
• Current procurement prices should still be
lowered (more sources, intelligence, regional PP)
• Get all essential medicines registered with PRA
• Local production capacity available (4 plants)
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But needs viable market (export! Zambia too small)
Good quality (GMP), registration (PRA)
Technology transfer, innovation, competent staff
From where to get the APIs patented elsewhere?
• Ensure that public health TRIPS flexibilities and
art 31bis are included in new Zambian Patents Bill
• Think regional!
THANK YOU
[email protected]
skype: wilbertb1
www.sarpam.net