A matter of life and death

Of all the issues currently being negotiated on the Trans-Pacific Partnership Agreement agenda, none is more important than the ability of patients to get life-saving medicines at affordable prices, which many fear may be a victim of the agreement.

Martin Khor

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IF you or some family members or friends suffer from cancer, hepatitis, AIDS, asthma or other serious ailments, it's worth your while to follow the Trans-Pacific Partnership Agreement (TPPA) negotiations.

It's really a matter of life and death. For the TPPA, a proposed trade agreement for the Pacific Rim region, can cut off the potential supply of cheaper generic medicines that can save lives, especially when the original branded products are priced so sky-high that very few can afford them. 

The fight for cheaper medicines has moved to cancer and other deadly diseases, when once the controversy was over AIDS medicines.

In February, a cancer specialist in New Zealand (one of the 12 countries negotiating the TPPA) warned that the TPPA would prolong the high cost of treating breast cancer because of new rules to protect biotechnology-based cancer drugs from competition from generics.  And this will affect the lives of cancer patients.

Some cancer medicines can cost a patient over $100,000 for a year's treatment, way above what an ordinary family can afford. But generic versions could be produced for a fraction, making it possible for patients to hope for a cure and a reprieve from death.

In India, local companies are leading the fight to make medicines more affordable to thousands of patients suffering from breast, kidney, liver and gastrointestinal cancer and chronic leukaemia. 

For example, an Indian company produced a generic drug for kidney and liver cancer more than 30 times cheaper than the branded product ($140 versus $4,580 for a month's treatment) after it was given a compulsory licence. 

India has a patent law that disallows patents for a newer form of drug unless it improves the medicine's efficacy or effectiveness. Under World Trade Organisation (WTO) rules, countries are free to set their own standards for novelty, or whether a product is novel enough to be eligible for a patent.

Also, in many countries, the patent law allows for companies to obtain compulsory licences to import or make generic versions of original medicines. Governments grant such licences if the branded products are too expensive and the originator companies do not offer attractive terms for a voluntary licence to other firms.

Data exclusivity

Multinational companies have strongly opposed compulsory licences or the Indian-type laws that allow for patents only for genuine innovations.

This is where the TPPA comes in. Mainly at the insistence of the United States, the other countries negotiating the TPPA are being asked to accept 'TRIPS-plus' standards of intellectual property protection that go beyond the rules of the WTO's TRIPS Agreement on intellectual property rights.

Especially noteworthy is the US insistence that the TPPA countries agree to give a type of intellectual property known as 'data exclusivity' for five years to companies producing original medicines. This is extended to eight or 12 years for 'biologics', or medicines made with biotechnology. Many of the new medicines for treating cancers are biologics.

This will cause immense problems for patients waiting for cheaper medicines because data exclusivity prevents generic companies from relying on the safety and clinical trial data of the originator company to get safety clearance for their generic products.

Thus, even if a generic company can prove that its medicine is bio-equivalent to the original medicine that has already passed the safety standard required by the health regulatory authorities, it will not be allowed to sell its medicine unless it comes up with its own safety and clinical trial data. 

This goes against current practice relating to generic medicines and safety standards. But the US is insisting on this in the TPPA.

Few generic companies have the funds or technical ability to do their own clinical trials, and thus generic medicines could well be prevented from being used in TPPA countries for five to 12 years - even if the medicines are not patented.

Being deprived of affordable medicines is a matter of life and death, and will cost many lives.  That is the most outrightly significant aspect of the TPPA, and this is why so many groups of patients, health organisations and independent medical experts have been outraged and outspoken in their opposition to the TPPA.

George Laking, a cancer specialist in New Zealand, has raised the alarm that the TPPA could make cancer treatment unaffordable because the data exclusivity clause would lock in the extraordinarily high prices of cancer drugs.

In a 21 February article in the New Zealand Herald, Laking uses the example of Herceptin, an anti-cancer medicine which costs $100,000 for a year's treatment.

Once Herceptin comes off patent, it will become cheaper because generic forms can be made, he says. Also, new medicines that have fewer side-effects and greater efficacy are being developed all the time.

That means more people will get through the treatment with less pain and distress. But the cost of new 'generic' versions of Herceptin and other such pharmaceuticals looks likely to become a casualty of the TPPA, said Laking.

'The new drugs will stay expensive for longer, because access to generic versions will be delayed between eight and 12 years' because of the new data exclusivity rules in the TPPA, he remarked.

'These extended monopoly rights go far beyond existing international norms. This would be the first time in the history of such agreements that exclusive long-term monopoly rights over these "biologic" medicines will have been guaranteed.

'Each additional year of exclusivity will cost consumers and taxpayers many millions of dollars. This will be profitable for the pharmaceutical industry, but not so good for cancer patients and their families.'

According to Jamie Love of Knowledge Ecology International, an expert on drugs and patents, the average cost of eight biologic cancer drugs registered with the US drug authorities in 2011-13 is $128,000 (for a year's treatment), with the most expensive being over $390,000. At such prices, hardly anyone in developing countries can afford these medicines.

On 12 February, several prominent organisations including Medecins Sans Frontieres, Oxfam, Public Citizen, Health GAP and Knowledge Ecology International issued a strong statement on their deep concern about the public health implications that the TPPA's measures will have for millions of patients in need of access to affordable medicines around the whole Asia-Pacific region.

The groups said that the TPPA negotiations must take into account the health needs of all patients living in TPPA countries, and the US must halt its efforts to limit countries' freedom and flexibilities, otherwise the TPPA will 'jeopardise many, if not millions, of lives'.

Prioritising public health

Developments in India, which is not a TPPA country, show the patient-friendly policies that can emerge when public health concerns are given priority.

Two generic companies are producing generic versions of the drug sorafenib which treats kidney and liver cancers. The original product, named Nexavar, cost some $4,600 per patient per month.  A compulsory licence was granted to a local firm to produce a generic version of sorafenib for $140 a month, or over 30 times cheaper.  

Another Indian company is producing a generic version of the drug Gleevec, which is used to treat a chronic form of leukaemia as well as gastrointestinal cancer, bringing the cost of treatment down from $70,000 a year (in the US) to $2,500 a year in India. This was possible because the Indian government denied the originator company a patent on Gleevec because it was not judged to be novel enough, and an objection to that decision was rejected by the Indian Supreme Court.

India also rejected a patent application on tenofovir, a drug to treat AIDS, after opposition to its application was filed by several organisations. Cheaper generic versions are now available.

Another Indian company Biocon has produced a generic version of the breast cancer drug Herceptin. Due to a challenge by the originator company, its production has been stalled. There is a citizens' campaign on affordable trastuzumab (which is the non-proprietary name for the drug) to make the drug available cheaply.  

Countries that join the TPPA will find it very difficult or impossible to undertake policies and practices similar to India's, should the US proposals in the intellectual property chapter be accepted.

Moreover, countries that don't produce the generic drugs have the option to import them from India. But if the TPPA imposes data exclusivity rules of the type desired by the US, it would be difficult or impossible to sell them in these countries.

Patients would be deprived of the much cheaper generic medicines for treating cancer, hepatitis, AIDS and many other diseases, at least for many years. How many lives would be affected?

Some countries are however opposed to some of the US proposals. According to a briefing on the TPPA by the Malaysian Ministry of Trade and Industry on 20 February, the intellectual property chapter remains the most problematic, with many differing views.

Of these views, the positions that defend public health must prevail, for after all, it is a matter of life and death.                                                     

Martin Khor is Executive Director of the South Centre, an intergovernmental policy think-tank of developing countries, and former Director of the Third World Network.

*Third World Resurgence No. 283/284, Mar/Apr 2014, pp 15-16