The Royal Commission on Genetic Modification - submissions

Researched Medicines Industry Association (RMI)

STRATEGIC OPTIONS & ISSUES

Submission

RMI stated that the most appropriate strategic option is to adopt and embrace biotechnology developments in light of the benefits and opportunities for health and welfare. These benefits and opportunities have been well documented in previous submission (see for example submissions from the University of Auckland, the University of Otago, the Malaghan Institute, and Genesis Research and Development Corporation Limited). This acceptance must coincide with a flexible and scientifically valid evaluation and control of the technology. In their opinion, to use products derived from GM technology but deny research, development, and manufacture of these products would imply a double standard.

RMI submitted that restrictions on access to new biomedical developments would have a serious effect on public health. This would result in New Zealand becoming reliant on older medicinal sources. This is a dubious proposition from both an ethical and economic standpoint. For example, older sources are less safe, less efficient, and would eventually become more expensive to source. Furthermore, New Zealand does not have the international strength to influence overseas markets to supply its particular needs. The country would then be faced with the stark choice of either GM derived products or no products at all.

It was also noted that biomedical research is developing into a real-time global collaboration. The Human Genome Project was given as an example of this collaborative approach. In cutting itself off from GM technology New Zealand could be denying itself the opportunities inherent in such international collaboration and cooperation. Furthermore, with current communication technology there is no reason for New Zealand scientists to leave the country in order to contribute effectively.

LAW & LEGISLATION — SECTIONS A(1), B(d), B(e), B(m), B(n)

Submission

Regulation

An inefficient double jurisdiction over pharmaceutical products was highlighted by RMI. This is due to the possibility that pharmaceutical products may come under both the HSNO Act 1996 and the Medicines Act 1981. The RMI recommended the removal of this anomaly for the following reasons:

The information requirements that pharmaceutical companies must supply to the Ministry of Health in regard to, and in support of, their new medicines’ application are based on international standards and best practice;

These comprehensive requirements are necessary to ensure detailed and extensive, research about the medicines has been undertaken by the companies, and that rigour is applied to the analysis of the information gathered from pre-clinical and clinical studies;

The purpose of this extensive approval process is to assure the public, using the best scientific means available, that all products granted approval meet the highest standards of safety;

Therefore all medicines, whether they are the result of conventional development or GM technology, and whether or not they contain a GMO, have to be evaluated for their safety, efficiency and quality prior to being given consent to market in New Zealand;

Rigorous post-marketing surveillance is also undertaken by the regulatory authorities and pharmaceutical companies. In the event of serious safety concerns a medicine is recalled and in rare cases, the approval is withdrawn;

Furthermore, the Ministry of Health is planning new health care and therapeutic products legislation to replace the existing Medicines Act and Regulations. This would provide for the principal legislation governing medicines to include an environmental analysis. This would prevent current duplication with the HSNO Act;

Regulations could also be developed over time to accommodate new developments in biomedicine;

ERMA, on the other hand, has no expertise in the evaluation of medicines from a human health and safety perspective.

Liability

The RMI outlined liability issues as seen in the US. In that jurisdiction approval does not protect the applicant from liability for damage caused by their products. By far the greatest deterrence in the US, however, is the possibility of court proceedings with concurrent high dollar value settlements. In the New Zealand jurisdiction proceedings could be instituted under the Sale of Goods Act, the Consumer Guarantees Act and the Fair Trading Act in respect to the sale of medicines in New Zealand. The RMI also noted that claims for personal injury through medical misadventure were barred under ACC legislation. Exemplary damages may be awarded but only in the case of an insolent disregard for the consumers position.

Intellectual property

Intellectual property rights were stated to be the cornerstone of biomedical research and essential to availability of new medical therapies. They stated that without solid economic assurance research would not be conducted in this area. The RMI submitted that patent protection for genes as discovered, products and manufacturing processes, is entirely appropriate. The same concerns were voiced in respect to the loss of intellectual property rights if GM technology was restricted in New Zealand.

Our Royal Commission homepage