TPPA's 'evergreening' may keep medicines out of reach

Excessive patent extensions of up to 20 years at a time could keep affordable medicines and medical diagnostic equipment unavailable almost indefinitely under the Trans-Pacific Partnership Agreement (TPPA), warned the group Bantah TPPA.

“It is called ‘evergreening’ in patenting terms. It is called evergreening because it lasts forever,” said Malaysian AIDS Council policy manager Fifa Rahman, whose NGO is a part of Bantah TPPA.

She said patents for these items are currently protected for a 20-year period, but TPPA would provide extensions under certain circumstances.

“For example if you have a cancer medicine but at the end of the 20 years, they discover the cancer medicine could also cure HIV.

“That is a new use of the medicine, so where there is a new use, it will be extended for another 20 years.

“At the end of that 20 years, if they change that medicine that is now being used to treat HIV into a liquid form, or they add strawberry flavour for children, it is a different form. If it is a different form, an additional 20 years.

“That is what the US wants and that is what the Malaysian proposal is against,” she said at a press conference today, which was held to provide a preliminary analysis of the leaked draft of the TPPA chapter on intellectual property.

She added that if there is any “unreasonable delay” in granting of the patents, the patent holder is entitled to another five-year extension on that patent.

She said the draft agreement, if finalised, also allows drug companies extensions to withhold information related to the drug garnered from in-house testing (data exclusivity), such as how well it stores at room temperature or how it performed in the clinical trials.

Patents on medicines and medical diagnostics prevent third-parties from producing generic versions of the drugs and equipment while it is in force.

This forces patients and doctors to purchase drugs and equipment from the company that had developed it or its licensees instead of the cheaper but identical generic versions.

Compulsory licences

Fifa added that while TPPA allows for countries to issue ‘compulsory licences’ in the event of a health emergency such as epidemics, this could be overridden by TPPA’s provisions on data exclusivity.

She explained a compulsory licence allows for countries to ship in generic versions of a drug if the patent-holder could not supply it in sufficient quantities to address the emergency.

“Information about the medicine is secret and that could override the licence. We don’t know that yet and I will be analysing the text more over the next few days.

“But we could have this situation where there is an infectious disease, Nipah virus for example; we issue a compulsory licence to bring the medicine in, but there is a data exclusivity period that hangs over it.

“So these Malaysians are dropping down and dying, and they still don’t get the medicine because of data exclusivity... We really need to preserve our right to compulsory licences because that is what could save us in an emergency,” she said.

To a question, Malay Economic Action Council (MTEM) CEO Mohd Nizam Mahshar (right) said the leaked draft document, which was posted on Wikileaks’ website on Wednesday, is still too preliminary to determine whether Malaysia has agreed to any provision that may be detrimental to Malaysians’ interests.

Thus far, Fifa said, a bloc of five countries including Malaysia is protecting access to affordable healthcare and opposing TPPA provisions that threaten it.

The other four countries opposing the provisions are Singapore, New Zealand, Canada and Chile, while other countries also joined in to oppose parts of the agreement such as on data exclusivity.

However, she said the fight against TPPA needs to continue and heads of state, ministers and chief ministers may still decide otherwise.

In addition, she warned that the US may attempt to bulldoze through the patent extensions by lobbying with seven other countries in the secretive TPPA negotiations that are not opposed to it.

Meanwhile, Mohd Nizam said the extensiveness of the 95-page document also came as a shock, because as recently as the July talks in Kota Kinabalu, rumours were circulating that there is still no written draft proposal tabled.

The leaked document is dated Aug 26-30, during the TPPA talks in Brunei.

'No details given'

He lamented that although the International Trade and Industry Ministry (Miti) has held two open days to discuss TPPA with stakeholders, the discussion was general.

While assurances were given that Malaysia would oppose some issues, he said no details were given on what were the contentious issues in the agreement.

In contrast, he said the US had some 600 advisers representing various industry stakeholders who have access to the draft document.

“Looking at the extensive text on the intellectual property chapter alone and what could have been concluded in other chapters (compared to the extensiveness of the consultation), for us this is a worrying trend,” he said.

He said while he does not support a full public release of the draft agreement, key industry stakeholders and civil society groups should have been involved.