ZIMBABWE, & HIV and AIDS hit countries, face anti-retroviral drugs crisis as ARV’s will be back on patent and cos tover US$10 000 per year per patient when India stops making generic ARV’s soon

ZIMBABWE, among other HIV and AIDS hit countries, is staring at a potential dilemma in accessing anti-retroviral drugs as indications are that the drug will be back on patent where it will cost more than $10 000 per year per patient as India will soon stop making generic ARV’s that are cheaper.

Zimbabwe was accessing most of its ARVs, for example the Aids triple therapy, at an average of $200 per patient per year but the same drug costs between $10 000 and $15 000 when it is procured from Western countries. Under international laws, when new medicines are discovered, the owners of the medicine will take out a patent on it. This is a legal entitlement which will grant the owners a monopoly of 20 years to manufacture, market, distribute and license to other parties under royalty.

According to the World Health Organisation (WHO) since 1970, India’s Patent Act has allowed Indian manufacturers to legally produce generic versions of medicines patented in other countries. India’s expertise in reverse drug engineering and the efficiency of its pharmaceutical manufacturing industry fast established it as the prime source of generic medicines in the world.

However, officials said the 20-year monopoly will come to an end by next year, putting countries that relied on India for supply at risk. The director of Aids and TB Unit in the Ministry of Health and Child Care, Dr Owen Mugurungi, confirmed that supplies from India might dry up in the coming year.

“It is true that India is expected to be TRIPS (Trade-Related Aspects of Intellectual Property Rights) compliant in the coming year or so. Under the TRIPS agreement, countries can invoke compulsory licensing which means Zimbabwe will not sit back, but will explore options for local licensing and we have started exploring on ways to capacitate the local pharmaceutical industry in the local production of ARVs,” he said.

Dr Mugurungi said patenting of ARVs if fully implemented, will have cost implications on the quantities of medicines that can be procured using the same resources available from the country and or those that would have been committed from development and funding partners.

“This ultimately will have a limitation on the total number of patients that can be covered on treatment and subsequently on the global drive towards meeting the 90-90-90 targets. As shared before this has potential implications at global level (including Zimbabwe) and should not be looked only at country level. Targets are always set at global level after factoring in total anticipated funding to be availed towards fighting the epidemic and the current HIV epidemiological progress status and this will definitely have implications on the total number of clients to be covered on treatment,” he said.

Asked on what can be done in order to ensure that those already on treatment are guaranteed of getting drugs if India stops manufacturing generics, Dr Mugurungi said:

“In Zimbabwe’s context, all our patients for 2016 and 2017 (those currently in care and those anticipated to be commenced on treatment) will be fully covered in terms of access to medicines as procurement processes of the bulk of ARVs to be utilised have already been finalised (procurements are done nine months prior).

“Hypothetically if India stops manufacturing ARVs at the end of this year, we will be covered for 12 months plus during which the country including the global community is to strategise on the way forward. Under the current procurement arrangement, in addition to procurement of ARVs stocks for clients in care, a six months buffer stock is always procured at the same time to avoid stock interruptions due to unforeseen circumstances,” he said.

Dr Mugurungi said there were also several other measures being put in place including courting the private sector to explore ways in which local production of medicines including ARVs can be supported.

He said plans were through regional trade blocs to support regional initiatives which promote free trade and the setting up of regional pharmaceutical manufacturing hubs of ARVs in partnership with Indian companies who have experience.

Continuing access to affordable medicines is possible by making use of the flexibilities included in the TRIPS agreement. For instance, TRIPS allows countries to overcome patent barriers by issuing compulsory licences or licences for government use, which allow the production or importation of generic medicines without the consent of the patent holder.

Zimbabwe amended its law in 2002 to fully comply with the terms of the Trips Agreement.

“We should have waited until 2005 before we complied with the Trips Agreement. By adhering to the terms of the TRIPS Agreement prematurely, the country forfeited its rights to utilise the flexibilities that we had in terms of the agreement. India, on the other hand, took the opportunity to grow its pharmaceutical industry by manufacturing generic medicines.”

The legal expert explained that middle income countries were not obliged to protect patent rights until 2005, and as a result had the liberty to manufacture medicines that were under patent. Medicines under patent tend to be more expensive as the patents create monopolies which, in turn, drive up product prices.

“For instance, the price of antiretroviral medicines were between US$10 000-US$15 000 per year per patient in 1996, but this cost came down to less than US$300 when generic ARVs started being manufactured in India. As Zimbabwe had a thriving pharmaceutical manufacturing industry, this would have been an opportune time to take maximum advantage of the situation,” he said.

The country did manufacture some generic ARVs through Varichem Pharmaceuticals which had been granted a compulsory licence by the Government. A compulsory licence is one of the flexibilities under the TRIPS Agreement which allows for the generic manufacture of patented medicines under certain conditions. However, the legal expert explained that the issuing of the compulsory licence would have been irrelevant had the country not adhered to the TRIPS Agreement.

However, despite having missed the opportunity to grow its pharmaceutical industry through using the TRIPS flexibilities, Zimbabwe does have a number of other flexibilities available.

According to Mr Washington Matika of the Southern African Regional Programme on Access to Medicines and Diagnostics (SARPAM), the country should move to ensure that all the flexibilities are incorporated in the national legislation, as well as ensuring that the National Intellectual Property Policy for Zimbabwe is approved by Cabinet.

The policy, which was validated in 2015, provides for the full utilisation of the TRIPS flexibilities by the Government.

However, the policy has not been approved by Cabinet and remains on the shelf to date, sources claimed. Mr Matika added that the TRIPS flexibilities were factored into the agreement to ensure that developing countries continued to access more affordable medicines for their people, thus shielding them from the harsh terms of the TRIPS Agreement.

Mr Matika added that a conducive legislative and policy environment in Zimbabwe can enable the country’s pharmaceutical industry to manufacture generic ARV’s as well as anti-TB, malaria and cancer medicines at a cheaper price.

He also lamented the fact that foreign donors are providing the bulk of Zimbabwe’s ARVs requirements, and in the event of them pulling out, there will be serious challenges in the health sector due to the country’s lack of generic manufacturing capacity. This will result in the medicines becoming expensive for the majority of the population. Robin Muchetu, Source-sundaynews