Pharmaceutical Patents, TRIPS Flexibilities and Access to Medicines

in Zimbabwe

Presentation to Civil Society meetingHarare

21 January 2014

Patents make medicines unaffordable!Patents create monopolies and dependencies

Beneficial for R&D companies (in rich countries)Limited value for Zimbabwe (mainly importing;

very few innovations to be patented)May affect access to medicines and pooled

procurementDrug companies make money from patentsWhy did Zimbabwe then sign this agreement?

WTO gives other benefits (export to EU etc)Trade stronger in IP policy than HealthStrong lobby by rich countries, WIPO etc

Remember the South Africa case?Antiretrovirals were unaffordable

$7000-12000 pp/year due to patents big farmaGenerics cheaper ($900, then $360 now $62)But generics were not accessible due to patents

SA govt made a law to make patented medicines cheaper; Drug companies sued Nelson Mandela’s govt

TAC South Africa and MSF won South African case Not with lawyers but with activists testifying in court,

press releases,TV interviews, public pressure etcCan civil society do this again?

Big farma vs South Africa on IP policy in 2014!

Useful but patented medicines2nd and 3rd line ARVsCancer medicinesNew antibiotics (resistance!)Non-communicable diseases

DiabetesCardiovascular diseasesHigh blood pressureStroke

Some are not considered essential as they are so expensive: catch-22 situation

Need civil society to demand access to these medicines!

Zimbabwe and patentsZimbabwe may have patents on ARVs, cancer

medicinesPatents may also have been granted by ARIPO

Not being an LDC, Zimbabwe cannot refuse or ignore patents on medicinesARVs have been produced in Zimbabwe thanks

to a “Government Use” compulsory license (unique in SADC)

And imported as generics from IndiaSo why worry about TRIPS?

Why worry about TRIPS?Fact: as WTO member it has to respect TRIPS

minimum, and grant pharmaceutical patents Good news: Zimbabwe has used its powers to allow

national production under a comulsory licenseBad news: India can no longer make generics for

newly patented medicines since 2005Who will make the generics??

Zimbabwe is discussing new IP PolicyUse the current debate among Trade, Justice & IP to

ensure that the maximum of public health flexibilities are built into the Patents Act

And think of local/regional production of new generics!

SADC Pharmaceutical Business Plan1. Regional assessment of IP legislation (done)2. Identify legal resources (done)3. Database of legal experts (available)

4. Collaborate with partners to enable countries to take full advantage of the flexibilities

5. Avoid TRIPS+ in bilateral trade negotiations

Zimbabwe best uses a strategy to:Fully use the LDC exemption for TRIPS until 2021

Refuse any new pharmaceutical patentsIgnore existing patents (using para 7 of Doha

Declaration)Buy generics

Enter only the minimum required of TRIPS in Patent Law

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!)

Regional Challenges, OptionsPatents are granted due to weak assessment

capacityARIPO (in Harare) was created to assist countriesDatabase of patented medicines in SADC

countriesIncorporate and use maximum flexibilitiesRegional production of new generics in LDC Avoid TRIPS+Consider Competition Law (SADC policy 2008)Cave anti-counterfeiting laws endangering

generics

What can civil society do?Take part in technical working group of Health,

IP and Trade officialsReview the Zimbabwe IP policyEnsure rights of patients, and access to future generics!

Assessment whether current patents are posing a problem for Zimbabwe’s access to medicines, e.g.:2nd and 3rd line ARVs, cardiovascular, diabetes, cancer

Discuss options of future regional production of new generics in Zimbabwe, SADC and Africa

Share information and learn lessons with other SADC CSO

Support is availableLegal expertise is available

to explain/discuss the legal details or Help to fix your national IP and patents

legislation.SARPAM support available to SADC

Secretariat, member states, private sector and CSONational civil society planningRegional consultation on TRIPS for CSO?

CSO voices need to be heard!

AcknowledgementsBased on

Flexibilities paper by Sisule F. MusunguConcept paper by Wilbert Bannenbergpresentation drafted by Elijah MunyukiComments by Aarti Patel, SARPAM Technical

Adviser

Further contact?Wilbert Bannenberg, wilbert@sarpam.net