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Appendix III

Problems associated with revoking either a patent or a notice of compliance

Paragraph 66(1)(d) of the Patent Act provides that the Commissioner of Patents may order revocation of a patent only when he is "satisfied that a case of abuse of the exclusive rights under the patent has been established" in defined circumstances, and only where the exercise of his other powers does not remedy the situation. The failure of a company to provide compassionate access to an experimental drug is clearly unrelated to the protected "art" of a patent and, accordingly, it cannot be used as an excuse to revoke a patent. Further, it would not be practical to amend the Act to include a revocation clause that would be triggered by the refusal of a company to provide compassionate access to an experimental drug, because such action would, in nearly all circumstances, contravene a treaty, convention, agreement, or commitment to another country. For instance, Article 1709, paragraph 8, of the North American Free Trade Agreement forbids the revocation of a patent except in two sets of circumstances, both of which are not relevant to the issue of compassionate access. In addition, paragraph 7 indicates that the length of a patent could not be reduced should a drug manufacturer decline to offer compassionate access, nor could it be increased as an incentive to offer compassionate access. This is because such a measure would impose more stringent or more advantageous conditions solely on holders of pharmaceutical patents. The same conclusion would seem to hold with respect to sections 44 and 45 of the Patent Act, establishing the duration of patents in Canada.

The second proposal that the government of Canada "take away the marketing rights for another product that the company sells in Canada," is flawed, particularly for ethical reasons. During the five Round Table sessions, a recurrent theme was the need not to pit one disease against another. The following question was distributed to participants before the fifth Round Table session: "in the event that Health Canada did not agree with the level of compassionate access Glaxo-Wellcome was providing for a new anti-retroviral, would the HIV/AIDS community be firmly behind a government decision to revoke Glaxo-Wellcome's notice of compliance for 3TC?" James Kreppner, Canadian Haemophilia Society, stated:

Certainly I think the proposal envisions a drug being chosen that perhaps has many competitors in the market and perhaps even has nothing whatsoever to do with AIDS and whose lack is not likely to have a significant impact on people's health.(1)

(1) Meeting No. 3, 1 May 1996, p. 10.

At first consideration, this response does not sound unreasonable, however, who decides which notice of compliance will be revoked? Who takes responsibility for the decision that a cream to treat psoriasis will be taken off the market rather than an ointment for ring-worm if the parent company refuses to grant compassionate access to its experimental cancer drug? Who makes the moral decision which physical ailments will be pitted against each other?

It was noted that this proposal is in opposition to the spirit of the Food and Drugs Act. The Act prohibits the sale of drugs that are not of proven safety and efficacy. Further, it would be in violation of The Department of Health and Welfare Act, in that it would hinder the ability of the Minister to promote and preserve the health of Canadians.

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