We should not change laws to fit TPP

A new article in a prestigious journal reminds us why the patent clauses in the TPPA should not be implemented, especially now that the TPP may never see the light of day.

LAST week a very interesting article on why medicine prices have become far out of reach of the ordinary person was published in The Lancet, one of the most prestigious medical and health journals in the world.

The authors pinpointed trade and investment agreements for being a major health trap.

Reading their short but powerful commentary leads one to think: What’s the point of having wonderful medicines if most people on Earth cannot get to use them? And isn’t it immoral that medicines that can save your life can’t be given to you because the cost is so high?

The article picks on the TransPacific Partnership (TPP) agreement as a key example. It says the TPP’s chapter on intellectual property is “particularly intrusive to health and restricts access to the latest advances in medicines, diagnostic tools and other life-saving medical technologies.”

The Nobel-winning medical group, Medecins Sans Frontieres (MSF), is even more scathing in its criticism.

“The TPP represents the most far-reaching attempt to date to impose aggressive intellectual property standards that further tip the balance towards commercial interests and away from public health.

“In developing countries, high prices keep lifesaving medicines out of reach and are often a matter of life and death.”

This issue is still relevant although the United States has withdrawn from the TPP. There are efforts underway to get the remaining 11 countries to put the TPP into effect without it. Moreover these countries, including Malaysia, have prepared changes to their laws and policies to comply with the TPP’s provisions.

The countries may continue their steps to implement these changes, even if the TPP actually never comes into effect. This would be an immense tragedy because most of these countries, including Malaysia, did understand that the Intellectual Property chapter would have negative effects on them, but they accepted it in order to benefit from getting better access to the markets of the United States and other countries.

Now it makes no sense to continue with the process of changing the country’s intellectual property laws in ways that are detrimental, when the benefit of market access is no longer available.

Thus, the ministries and departments in charge of health, patents, trade and law should be alert to the need to not implement any changes to the laws that would increase the barriers to access to medicines.

Members of the World Trade Organisation have to implement its intellectual property agreement, known as TRIPS, but not to take on any extra obligations, known as TRIPS-Plus. But the TPP has many clauses that are TRIPS-Plus.

First, a provision that lowers the standards a country can adopt to grant a patent. Some patent applications are not for genuine inventions. Under TRIPS, a country need not grant patents for simply modifying existing medicines.

The TPP (Article 18.37.2) requires countries to grant patents for at least one of the following modifications: new uses of a known product, new methods for using or new processes for using a known product.

Second, a provision that enables extending the patent term. TRIPS requires 20 years for a patent’s term, usually counted from the date of filing. The TPP requires the patent term to be extended beyond that if there are “unreasonable” delays in issuing the patents (Article 18.46), or if the effective patent term is curtailed because of the marketing approval process.” (Article 18.48).

Third, a provision (Article 18.50) to create “data exclusivity” or “market exclusivity”, that prevents drug safety regulators from using existing clinical trial data to give market approval to generic drugs. Under TRIPS, the clinical test data of a company can be used by a country’s drug regulatory authority as a basis to give safety or efficacy approval for generic drugs with similar characteristics, thus facilitating the growth and use of generic drugs.

Under the TPP, the data of the original company is “protected” and approval of similar drugs on the basis of such data is not allowed. The period of “exclusivity” is at least five years for products containing a new chemical entity, or three years for modifications (a new indication, new formulation or new method of administration) of existing medicines.

For “biologics” (Article 18.51) , which is a new and very expensive group of medicines for treating cancer, diabetes and other conditions, there is at least eight years of exclusivity or five years if other measures are also taken.

Fourth, a provision (Article 18.76) obliging members to allow the right holder to initiate action to detain any imported goods that are “suspected counterfeit or confusingly similar trademark”. This would open the door to blocking affordable generic medicines from entering the country. There have already been many cases where legitimate generic drugs have been detained due to actions by right holders, thus delaying treatment for patients.

All in all, these TPP obligations would make it more difficult for patients to obtain cheaper generics that could save their lives or alleviate their suffering. Thus much is at stake.

For example, there are hundreds of thousands of people in

Malaysia with Hepatitis C. They would certainly benefit from having access to new medicines that have cure rates close to 100% but the prices are reported to be over RM100,000 for a 12-week course of treatment.

In other countries like Egypt and India, treatment with good-quality generic medicines is available at less than RM3,000. With the use of TRIPS flexibilities, Malaysians too can have access to these generic drugs. But if the TPP clauses are translated into domestic law, this access could be blocked.

The lives and health of millions are at stake. Sometimes this is forgotten or put as a low priority when pitted against the promise of more exports in a free trade agreement.

But with the TPP in limbo and perhaps in perpetual suspension, there is really no reason why the provisions that have adverse effects should be implemented, especially when there are no benefits to be obtained to offset them.