TRIPS: The Post-Doha Divide - Issues for LDCs

By Asaf Shamsi, B. Pharm., MBA

Director,

International Operations

TRIPs, the intellectual property component of the Uruguay

round GATT Treaty, gave rise to an acrimonious debate between the developed

countries and less developed countries (LDCs). On one side, business interests

in the developed world claimed large losses from the imitation and use of their

innovations in LDCs. They also asserted that establishing strong intellectual

property rights would actually benefit the developing countries by encouraging

foreign investment, the transfer of technology and greater domestic research

and development (R&D). On the other side, LDC governments adamantly opposed

this view, worrying about the higher prices that stronger intellectual property

rights would entail and about the harm that their introduction might cause to

infant high tech industries.

No country was more actively involved in opposing this

component of the GATT agreement

than India and no part of TRIPs was, and continues to be,

more sensitive than product patents for pharmaceutical innovations. The

national sentiment on this issue is well captured in an often quoted statement

made by Indira Gandhi at the World Health Assembly in 1982:

"The idea of a better-ordered world is one in which

medical discoveries will be free of patents and there will be no profiteering

from life and death."

What is striking about the original TRIPs debate and the

continuing discussions about Pharmaceutical product patents is the divergence

between the strength of the claims made by both sides.

Although

developing countries have succeeded in getting some concessions with respect to

implementation of TRIPs at the Doha Ministerial Meeting, a solution

seems to be extremely evasive, so far, even one year after the Doha

Declaration.

The World

Trade Organisation is hoping to secure an agreement to relax the rules on drug

patents as part of the current round of international talks. However, up to as

recently as November, 2002, trade ministers have so far failed to reach

agreement after almost a year of negotiations.

Numerous experts have warned that millions of people in the

developing world will miss out on life-saving drugs if governments fail to strike

a deal on cheap medicines.

According

to Dr Carlos Correa, a member of the UK government's independent commission on

intellectual property rights, there is no easy solution to the problem. He is

not really confident that there will be agreement on this before the end of the

year, and predicts that the issue will continue to be on the agenda causing

very measurable frustration for developing countries. He says that although the

simplest and most effective solution would be to allow any country to produce and

export generic drugs without restrictions, a clear legal framework is needed.

The

TRIPS Agreement allows those Members that did not provide patent protection

until January 1, 2005 to implement it. In the interim, under the so-called

ìmailboxî rule, developing countries are required to establish mechanisms for

receiving and preserving priority in regard to pharmaceutical patent

applications, and to allowing for the grant of exclusive distribution rights

when prescribed conditions are satisfied.

The

Doha Declaration on the TRIPS Agreement and Public Health states:

ì4. We

agree that the TRIPS Agreement does not and should not prevent Members from

taking measures to protect public health. Accordingly, while reiterating our

commitment to the TRIPS Agreement, we affirm that the Agreement can and should

be interpreted and implemented in a manner supportive of WTO Members' right to

protect public health and, in particular, to promote access to medicines for

all. In this connection, we reaffirm the right of WTO Members to use, to the

full, the provisions in the TRIPS Agreement, which provide flexibility for this

purpose.î

Paragraph 4 is stated in terms of an agreement among WTO

Ministers acting on behalf of Members. This agreement is most reasonably

considered a ìdecisionî of WTO Members under Article IX:1 of the WTO Agreement,

and to be the substantive equivalent of an interpretation of the TRIPS

Agreement.

The Doha Declaration at paragraph 7 also directed the TRIPS

Council to authorize the extension until January 1, 2016 of the transition

period for least developed Members (hereinafter ìLDCsî) to implement or enforce

pharmaceutical patent protection.

The Doha

Declaration on the TRIPS Agreement and Public Health mandates that the

agreement be interpreted in a manner that supports public health interests and

promotes access to medicines for all.†

However, notwithstanding the political and legal success it represents

for developing WTO Members, the Doha Declaration did not address and resolve

many of the significant obstacles the TRIPS Agreement creates regarding access

to medicines and vaccines.

There are important lessons to be learnt from the

devastating events of September 11 in the United States and the subsequent

change in the tide of world affairs.

The fears of further terrorist acts all over the world with...