The Effect of Patents on Access to Essential Medicines for HIV/AIDS in Developing Countries: With Malawi a Typical Example

• Citation: (2016) IPLJ 19
• Date: 24 May 2019
• Published date: 24 May 2019
• Author: Jacob Holland
• Pages: 19-46

THE EFFECT OF PATENTS

ON ACCESS TO ESSENTIAL

MEDICINES FOR HIV/AIDS IN

DEVELOPING COUNTR IES: WITH

MALAWI A TYPICAL EXAMPLE



PhD Intellectual proper ty law candidate, Xiamen Uni versity, China

   

Senior lecturer, Com munications theory, Exploits Uni versity, Malawi

  

Developing countries (DCs) and least-developed count ries (LDCs) are failing

            

(WTO) Agreement on Trade-Related Aspect s of Intellectual Proper ty Rights

(TRIPS Agre ement) to overcome patent barriers and, i n turn, allow them

to acquire the med icines they need for high-priorit y diseases, in par ticular,

HIV/AIDS.1 It is assumed that these problems are cause d by lack of

infrast ructure, lack of technology tra nsfer, lack of health and patent expertise,

and lack of political will, among other s. It is also believed that patent protection

makes the drug s expensive and inaccessible; there is a need for documentation

in Malawi to deter mine how true these assumptions are.

The TRIPS Agr eement came into effect on 1 Januar y 1995, setting out

minimum st andards for the protection of intellect ual property, including

patents on pharma ceuticals. However, the TRIPS Agreement incor porates

          

countries to use T RIPS-compatible nor ms in a manner that ena bles them

             

to pharmaceut ical products or protection of their biodiversity, or more

generally, in establishing mac roeconomic, institutional cond itions that

                      

study: the Mi nistry of Health a nd Population (MoHP), Dr Wyn n C Chalira (Pha rmacies, Poisons

and Medicines B oard), Chifwayo Ch irambo (Assista nt Registrar Gene ral), Mrs Nyiren da

(Pharma cies, Poisons and Medici nes Board). Than ks are also due to M r Chikosa Banda , law

lecturer a t Chancellor College’s School of Law, a constit uent college of the Univer sity of Malawi,

for his great help i n this article.

    

1 For the purpose of this stud y, Malawi will be used as a r eference nation for lea st-developed

countries .

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(2016) IPLJ 19

© Juta and Company (Pty) Ltd

support economic development.2 DCs and LD Cs are expected to make use of

       

     

    

as Malawi, remains to b e seen.

Malawi is a least-developed countr y with poor socio-economic ind icators,

particularly i n public health. It has a limited phar maceutical manufactu ring

         

foreign manufactu rers based in other countries. I n the case of relatively newer

medicines, some of which are covered by intellect ual property rights, Malawi

must import from br and-name manufactu rers. Where a patent bar doe s not

exist, Malawi relies on manufact urers based in I ndia and, to some extent,

China and South Af rica.

There has been a campa ign to make access to essential me dicines a reality

for all. In 2004, the Malawi govern ment introduced an Essentia l Healthcare

Package (EHP), to ensure that pe ople had a cost-effective package of essential

health services coveri ng 11 com mon diseases, among which malaria and HI V

and AIDS. Medicines were supp osed to be free at the point of delivery in public

hospitals and clinics. However, for this to be possible, strong governme nt

funding and st rong civil society program mes to track budgets for medicines

would be necessary.3 With respect to ant iretroviral medicine s, Malawi’s

HIV/AIDS treatment program me, funded by the Global Fund, relies almost

          

reliance is potentially problematic be cause some of the component medicines

are still patent-protected in Malawi.4

While AIDS med icines became available to most people living with

             

developing countries. Nevertheless, i n the past decade a sea change occur red

in global policy and thin king about access to AIDS medicines for the world’s

poorest countries. Un like most developing countries, India ha s had a unique

position among the countrie s in the developing world. It has a strong generic

pharmaceutical i ndustry that has been able to provide medici nes at prices that

are among the lowest in the world. Two key provisions facilitated this process

             

regime for chemicals, and the second , shortening of the life of patents granted

for pharmaceuticals. I ndia took full advantage of the ten-year t ransition period

to ensure patent prote ction for pharmaceuticals – which of course allowed it to

develop and maintain its massive gener ic production capacity for drugs t hat

were otherwise on-pate nt in developed and many developing countr ies.

2 WIPO ‘Advice on the flexibi lities under the TRI PS Agreement’ available at: http://www.wipo.

int/ip-development/en/legislative_assistance/advice_trips.html (accessed on 10 June 2016).

3 S Mazengera ‘Access to medic ines in Malawi: A bat tle for all, even presiden ts’ available at:

http://policy-practice.oxfam.org.uk/blog/2012/06/access-to-medicines-in-malawi (accesse d on

10 Jun e 2016).

4 B Chikosa, H Le wis A Survey of Policy a nd Practice on the Use of Acc ess to Medicines-Rel ated

TRIPS Flexi bilities in Malawi (20 04) 6.

20 South African Intellectual Property Law Journal (2016) 4

© Juta and Company (Pty) Ltd