Country Disputes: Our Concerns and What We Are Doing

As countries seek to make medicines affordable and speed access to generic competition, a number of disputes have emerged, both as to what is permissible under international trade rules and what is advisable as a matter of policy. Essential Action has sought to intervene in these disputes to clarify the flexibilities that countries have under international trade rules and advance the public health, human rights and economic policy rationales for measures to lower the price of medicines.

We also place a great emphasis on proactive work, providing educational materials and technical assistance to developing countries regarding the available measures to lower the price of drugs, especially through compulsory licensing.

Here’s more about our approach on these questions:

Global campaigns over the last decade have highlighted the flexibilities available to developing countries under international trade rules, but only about a half dozen have issued compulsory licenses.

Why have other nations not exercised the rights that they have fought so hard to defend at the international level and that can bring such clear public health benefits? The reasons are multiple. They include the fear that countries issuing compulsory licenses will face pressure directly from the U.S. government, threats issued by Big Pharma and their proxies, a belief that issuance of compulsory licenses will deter foreign investment, the political weakness of most ministries of health, and a culture of the sanctity of patent protection among many patent offices that have a key role in many countries’ compulsory license decision-making. Additionally, in the case of AIDS drugs, many countries have been able to reap the benefits of generic competition for first-line ARV therapies because those drugs are not patented in their countries; and even where the drugs are patented, the lower brand-name prices that followed from worldwide generic competition represent dramatic savings from the price available five years ago (though they are still typically 2-4 times higher than generic prices, even for first-line therapies).

But there are other reasons that compulsory licenses have not been issued. One is the remaining widespread misconceptions about the conditions under which compulsory licenses may be issued (notably the myth they compulsory licensing is possible only under conditions of emergency). A second is uncertainty about the mechanisms to issue compulsory licenses, and uncertainty about how to handle certain policy issues, notably the fixing of compensation to patent owners. Both of these apply to both governments and NGOs in developing countries. And a third reason is simple but in some sense the most important: with governments declining to act on their own, very few compulsory license applications have been filed, enabling governments to avoid making what they perceive to be controversial decisions on licensing.