Concerns over dearer drugs

Many health, medical and patient groups are protesting against proposals in the TPPA to boost patent rights and severely limit generic medicines.

PUBLIC health and patients' groups around the world have been protesting against free trade agreements that the United States and European Union are negotiating with developing countries, because of their effects on raising the prices of medicines, including for life-threatening diseases.

These bilateral or regional agreements would make it very difficult or even impossible for governments and patients alike to have access to the much cheaper generic versions of the medicines.

As a result, millions of patients could be deprived of life-saving drugs since they, and their governments, cannot afford to buy the branded products.

Their most recent concerns are focused on the Trans-Pacific Partnership Agreement (TPPA), which is being negotiated by the US, Australia, Malaysia, Brunei, Vietnam, Singapore, New Zealand and Peru.

For the TPPA's chapter on intellectual property, the US is proposing that the rights of patent holders (mainly big drug companies) should be tremendously elevated. This would be at the expense of generic drug producers, governments which often prefer to buy the generic drugs for their hospitals and clinics and, most of all, patients.

In the World Trade Organisation's (WTO) TRIPS Agreement, governments have the right to set their own standards for patents and to reject applications that they do not consider to be real inventions.

But the rules also allow governments to provide "compulsory licences" to other drug companies to produce generic versions of the patented medicines, on several grounds, including if the patent holder does not enable others to produce on reasonable terms, if there is an anti-competitive situation, and if the licence is in the public interest.

In some countries, like India, people are allowed to raise objections before and after a patent is granted.

In the TPPA negotiations, the US has proposed that the TPPA requires the countries to have patent laws that are stricter than the WTO's TRIPS agreement. They would increase the privileges given to drug companies that own the patents, and to curtail the ability of the governments to make use of the "flexibilities" that are allowed under the WTO.

An interesting paper by Médecins Sans Frontières (MSF), the Nobel prize-winning medical group, explains various ways in which the US proposals, if accepted in the TPPA, would threaten health interests.

It points out the importance of generic drugs. The first generation of HIV drugs have come down in price by 99% over the last decade, from US$ 10,000 (RM31,000) per person per year in 2000 to roughly US$ 60 (RM186) today, thanks to generic production in India, Brazil and Thailand, where these drugs were not patented.

This dramatic price drop enabled HIV/AIDS treatment to be scaled up for over six million people in developing countries.

According to MSF, the US proposals in the TPPA would cause the following problems.

First, it would broaden the scope of patentability: the US wants to make it easier to patent new forms of old medicines that offer no added therapeutic efficacy for patients. The WTO rules allow governments to decide what type of "innovation" deserves to be protected by patents.

However, the US proposal limits this ability to define what is "patentable" by requiring the patenting of a "new form, use, or method of using" an existing product – even if there is no increase in efficacy.

Second, the US wants countries to allow patents for plants and animals, and diagnostic, therapeutic and surgical methods for the treatment of humans, although the WTO's TRIPS Agreement allows countries to exclude patents for these.

Third, the US proposes restrictions on pre-grant patent oppositions, even though the WTO rules allow for this.

Fourth is the proposal to have new forms of IP enforcement, such as allowing customs officials to seize shipments of drugs, even if they are in transit, on mere suspicion of that they are counterfeit products, and to increase damages for IP infringement

Fifth, and most seriously, is the US proposal on "data exclusivity". This would prevent generic drug companies from using existing clinical research data (that had been submitted earlier by the originator drug company) to gain regulatory approval of their medicines, forcing them to perform duplicate clinical trials or wait for the "data monopoly" period to end.

Sixth, the US would like the term of the patents to be more than the 20 years in the WTO rules. The US is expected to seek to extend the patent period to compensate for administrative delays in the regulatory process.

Seven, the US is seeking to link patents with drug safety regulation, thus turning drug regulatory authorities into "patent police", according to MSF. In Malaysia, several patient and medical groups have issued a joint statement opposing the US proposals which they say will reduce access to medicines.

"We categorically oppose US demands for longer and stronger patents on medicines and medical technologies that are essential to save Malaysian lives," said leaders from the National Cancer Society Malaysia, Breast Cancer Welfare Association, Malaysian AIDS Council, MTAAG+, Malaysian Thoracic Society and Malaysian Mental Health Association.

They said that breast cancer requires affordable chemotherapy medicines. HIV second line medicines like Kaletra are required to save lives, and are often out of reach of persons living with HIV.

Many other conditions, such as cancer, tuberculosis, malaria and diabetes, depend on generic medicines.

They added that patented medicines are very expensive, for example, Glivec (for treating gastro-intestinal cancer) medicine costs RM10,000 per patient per month. Sorafenib Tosylate (for treating liver and kidney cancer) costs RM9,865 per person per month, whereas the generic version can cost RM370-RM501 per person per month.

They asked that the US proposals, including for patent extension, data linkage, and border control measures, be rejected.

The TPPA is being negotiated entirely in secret. These negotiations affect public health and must be conducted with adequate levels of transparency and public scrutiny, according to many organisations.

The situation is urgent, because the TPPA negotiations are taking place at a rapid pace and are scheduled to end this year.

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