Data exclusivity a life and death issue

Data exclusivity a life and death issue

During the last week of July, a team from the Department of Trade Negotiation (DTN) went to Brussels to work on a scoping exercise with the European Union Trade Commission. On their return to Bangkok a meeting was called by Deputy Prime Minister Kittiratt Na-Ranong at which officers from various government departments were present including, the DTN, the Food and Drug Administration, the Department of Intellectual Property, the Bank of Thailand and the Commerce, and Agriculture and Cooperatives ministries among others.

The meeting had been called in order to move forward the Thai-EU Free Trade Agreement (FTA) and the DTN, as secretariat of the meeting, reported back on the discussions they had with the commission in Brussels.

According to a leaked position paper of the DTN five sensitive issues were discussed; alcohol and tobacco, intellectual property rights, government procurement, competition and services. The document goes on to suggests that the Thai government take a flexible position on intellectual property rights during any negotiations with the EU by accepting the trade-related aspects of intellectual property rights (Trips) agreement plus provisions, although they recognise this topic is highly controversial among civil society.

In particular the DTN argue that five years of data exclusivity should be accepted as it would have no impact on the current price of medicine and that although data exclusivity might delay generic medicine's entry into the market by five years this would have very limited impact on overall access to medicines.

At the end of the meeting Mr Kittiratt said that negotiations with the EU should start as soon as possible; that there is no need to hold further public hearings and therefore the government will submit the draft framework of negotiation to parliament within the month.

This headlong rush into opening negotiations with the EU and the apparent willingness of the negotiators to offer to accept data exclusivity is extremely worrying to civil society groups and organisations who have seen the negative consequences on public health of such agreements.

We would therefore like to state clearly that data exclusivity is not currently required in international law. The Trips agreement requires member states to protect clinical data, but there is no obligation to grant any period of monopoly or exclusivity in the use of these data.

When a generic manufacturer applies to register and sell a generic version of a previously-registered medicine, the manufacturer has to provide data showing that their product is bioequivalent to the original registration. The drug regulatory agency already has the necessary clinical data for safety and efficacy, submitted by the originator, and must only assess if the generic version meets bioequivalence standards.

The introduction of data exclusivity prevents drug regulatory agencies from referring to existing clinical data to approve registration of generic versions of a drug by "locking up" the clinical data for a period of years, shutting down the entry of price-lowering generic competition for the duration of the exclusivity.

Data exclusivity essentially creates a new system for granting monopolies in order to prevent generic competition.

Generic manufacturers are forced to wait for the "data monopoly" period to end, even if the drug is unpatented, and even when a compulsory license is issued to override the patent.

The only way a generic manufacturer can get a drug registered without access to existing clinical data is to repeat the clinical trials. However, duplicating clinical trials is not only extremely costly, but also unethical, since safety and efficacy has technically already been established, rendering further clinical trials medically unnecessary.

Many experts and UN agencies, including the World Health Organisation, United Nations Development Programme and UNAids, have recommended developing countries do not incorporate data exclusivity in their national laws.

Data exclusivity can delay the registration of generic or biosimilar versions of a medicine for many years. Some of the newest breakthrough medicines are biologics sold at extremely high prices. The introduction of data exclusivity for biologics will delay the introduction of affordable versions of these medications. The need for low-cost biosimilar alternatives to highly expensive lifesaving drugs, including Pegylated Interferon to treat Hepatitis C and Herceptin to treat breast cancer, is acute.

Data exclusivity, when implemented in national law, provides a distinct monopoly from patent rights that often results in high prices and a delay in market entry of generics.

As a part of the United States-Jordan FTA, Jordan implemented data exclusivity. A study conducted by Oxfam in 2007 found that of 103 medicines registered and launched since 2001 that had no patent protection in Jordan, at least 79% had no competition from a generic equivalent as a consequence of data exclusivity. The study also found that prices of these medicines under data exclusivity were up to 800% higher than in neighbouring Egypt.

A 2010 study by the Centre for Policy Analysis on Trade and Health determined that once Guatemala enacted data exclusivity, some medicine prices rose as much as 846% _ even though just a handful of medicines were under patent protection.

Data exclusivity raises the price of medicines even when no patent exists. For example, in the US, the price of colchicine, a treatment used mainly for gout, rose more than 5,000% after data exclusivity was enacted.

Colchicine has been in use for thousands of years, costs almost nothing to produce, and cannot be patented. Therefore, generic formulations of the tablet have been widely available since the 19th century. However, a new monopoly on colchicine was created in 2009 when the US Food and Drugs Administration accepted clinical data from a one-week trial of the drug and granted data exclusivity to URL Pharma. URL Pharma subsequently sued to force other manufacturers off the market, and raised prices from US$0.09 to $4.85 per pill.

We would therefore take this opportunity to request that the Thai government take a firm position of refusing any Trips plus demands in all forthcoming negotiations with the European Union that would adversely affect the cost and consequent access to medicines and medical technologies.


Paul Cawthorne is an officer on the Access to Essential Medicines Campaign, Medecins Sans Frontieres.

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