New Organisms and Other Matters Bill

It is my pleasure to engage in the debate on Part 4. This part refers to medicines and to qualifying new medicines that would be available to the public. It is important to understand the process that would take place for approvals under the legislation as it is today. There is two-step approval. Two Acts have to be referred to. The first is the Hazardous Substances and New Organisms Act, and the second is the Medicines Act. Part 4 allows for what is deemed to be a qualifying medicine, and for the approval process that has to take place for a qualifying medicine. There is a process here whereby assessments of qualifying medicines would be made by the director-general, and, in particular, clause 56 refers to the situations where the director-general may grant a conditional release under section 38H of the Hazardous Substances and New Organisms Act. In particular, the director-general has to have the consent of the Minister, and he or she must be acting under a delegation from the Environmental Risk Management Authority given under section 19 of that Act.

It is important to look at what a qualifying medicine could be. I note for the Committee’s attention that these are medicines with likelihood of a low-risk to the environment—that is, the kinds of things that are very likely to get into the environment as we know it. This part also applies to veterinarians, not under the Medicines Act but under the Agricultural Compounds and Veterinary Medicines Act. For instance, they would be in the sort of situation where organisms are injected into a muscular part of the body—they are very unlikely to get into the environment, and are highly metabolic. Those are the kinds of situations we are talking about in particular.

I want to discuss for a moment within Part 4 the approval of emergency qualifying medicines. I will reflect for just a moment on the kinds of situations that I recently came across in the United Kingdom. Some members may remember that in parts of the United Kingdom various people have been suffering from CJD (Creutzfeldt-Jakob disease), which is a derivative of bovine spongiform encephalopathy. In a very interesting case a young man, unfortunately, contracted CJD in the United Kingdom. From memory, he was only 19 or 20 years of age. As members will probably be aware, it is a disease that leads to death.

Interestingly enough, the parents of the child actually petitioned the courts for 19 months to have approval of this medicine. The great tragedy of that was that after the courts allowed the approval of it, the young man has shown great signs of improving. It will not be enough to save his life, but we do have to ask the question whether had that great drug been approved earlier on it could have done more to save that young man’s life.

The area of medicines is very exciting. One of the great advantages of genetic modification as we know it is that it is likely to lead to people living a lot longer. I certainly hope that all members in this Chamber will live to well beyond 100, and I hope that it is as a result of this bill. I would like to know that my contribution in this debate was to encourage just a few more members to vote for it, and on the back of it that humanity lived longer. I know that not only my constituents, but also people up and down the country, would be very, very happy with that.

I do want to point out that situation, although I should also point out that should that provision of Part 4 be adopted, and emergency approval be given, there is a differing form of control over it, and use is dictated. That is covered in section 24D, “Approval of medicines required for use in special emergency”.

I raise a point of order, Madam Chairperson. I seek leave to amend my vote. When the vote was taken on Part 3 I inadvertently said there were nine votes. In fact there were eight votes.

Leave is sought for that purpose. Is there any objection? There is not. The result is now 92 in favour and 21 against.