One Paragraph And Two Articles

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: Law needs to be precise. Not ambiguous or vague. There is of course a difference between ambiguous and vague, although the two words are sometimes used synonymously. Vague means something that is not clearly stated. Ambiguous means something that is capable of more than one interpretation. Stated thus, ambiguity is a subset of vagueness, but not the other way round. Removal of ambiguity and vagueness reduces scope for subsequent disagreements and disputes.

Here is a statement that is ambiguous. “This chilling tale, told in a 13-page report released today by Edward F Stancik, the special commissioner of schools, raised serious questions about the detection and reporting of child abuse by school officials.” On the face of it, I don’t understand what this means and the sentence is ambiguous. Were school officials indulging in child abuse? Probably not. They were indulging in detection and reporting of child abuse. If this presumption is correct, the sentence should have been better drafted. Imagine what would have happened had a court case resulted. “Thou shalt not commit adultery,” is reasonably well-drafted law, although a reading of the Indian Penal Code will convince you that there can be subjectivity in interpreting the term adultery. “Thou shalt not covet thy neighbour’s wife,” is relatively worse, because coveting refers to a state of the mind. And this brings me to the ministerial declaration on the Trips agreement and public health, issued by the ministers in Doha on November 14 2001.

This is not quite law, but the issues are similar. Consider para 6, now widely debated in Geneva and elsewhere. “We recognise that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the Trips agreement. We instruct the Council for Trips to find an expeditious solution to this problem and to report to the General Council before the end of 2002.” If, following the second sentence, the Trips Council has to find an expeditious solution by the end of 2002, the Trips Council (and everyone else) has to understand what the first sentence means. Compulsory licensing and WTO members are concepts that are easy to pin down. But which are the countries that have insufficient or no manufacturing capacities in the pharmaceutical sector?

There are several WTO members that are small countries (and these may also be developed countries). There is no reason for them to have indigenous pharmaceutical manufacturing capacity. It doesn’t make commercial sense. Will the Trips Council also investigate what these small developed countries are supposed to do? There is no way they can make effective use of compulsory licensing. People will say that developed countries are not the problem, Doha meant developing countries and LDCs. But that’s not what Paragraph 6 says. And for developing countries and LDCs, is access to drugs at reasonable prices the issue or is effective use of compulsory licensing the issue?

The two problems are not synonymous. Because of the original vagueness in drafting, Geneva is now busy trying to interpret para 6. Take the three questions posed by Switzerland. “What is the meaning of insufficient or no manufacturing capacity? Which situations justify action? How can solutions be devised that genuinely help countries lacking production capacity rather than helping those with production capacity?” Developing countries think para 6 applies to all WTO members. Developed countries think it should apply to countries with specific eligibility criteria. Exclude small developed countries for example. Pity the ministers aren’t around to explain what they meant in Doha. So we still don’t know which countries para 6 refers to. The Trips Council has a task on its hands.

Other than pinning down countries, one also has to pin down difficulties in effective use of compulsory licensing. Does this imply incentives for technical assistance and technology transfer? What happens if drugs produced under compulsory licences in one country are exported to another country, with the second country, perhaps, having no domestic production capacity? This links up with Article 31(f) of the original Trips agreement, which states: “any such use shall be authorised predominantly for the supply of the domestic market of the member authorising such use”. Any such use means use without the authorisation of the right holder and covers compulsory licensing.

The evident problem is with the clause “predominantly for the supply of the domestic market”. Developing countries want this scrapped. The EU wants it amended, with strict criteria for exporting. The US only wants a moratorium on such export-related disputes. But in the case of Article 31(f), one can at least understand what different countries are saying.

Unfortunately, this is not what one can say of the other interpretation of para 6 floating around. This interpretation is that Article 30 of the original Trips agreement should be amended, so as to allow products made through compulsory licensing to be exported to countries that face public health problems, but have no domestic production capacity. Article 30 is on exceptions to patent rights and in my view, is another classic example of bad drafting.

Here is Article 30. “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.” This Article has a lot of nice sounding words, but what on earth does it mean? The Trips agreement has several articles on rights conferred by a patent. It also has several articles on exceptions to rights. Those articles are specific. But by virtue of being non-specific, Article 30 contributes nothing to general comprehension. The WTO’s dispute resolution mechanism has already had to interpret what Article 30 means. And thanks to para 6 and Doha, the Trips Council will now have to interpret what Article 30 means and possibly suggest amendments and explanatory notes. Wouldn’t it have been better had Article 30 been precisely drafted in the first place?