AIMS - POSITION STATEMENT -  Dec 2006

SUBMISSION BY
THE AUSTRALIAN INSTITUTE OF MEDICAL SCIENTISTS
TO THE CONSULTATION PAPER
ON THE PROPOSED REGULATION OF BLOOD UNDER ANZTPA

INTRODUCTION

The Australian Institute of Medical Scientists (AIMS) is a professional organisation representing some 2000 Medical Scientists from all disciplines of pathology and associated industries. It is involved in establishing and maintaining the high academic and professional standards of medical scientists employed in Australian medical laboratories. The Institute also provides medical scientists with the opportunity to continually update their professional knowledge through national and state scientific meetings, a scientific journal and postgraduate programmes such as the Fellowship. AIMS has a minimum requirements standards document for degree level courses in medical laboratory science offered by Australian universities and undertakes regular reviews to ensure the courses meet these standards.

AIMS is also the body to which the National Office of Overseas Skills Recognition (NOOSR) has delegated the authority to assess the skills and qualifications of those people who are applying to migrate to Australia under the Commonwealth’s General Skilled Migration Program as medical scientists or medical laboratory technical officers. AIMS carries out these assessments on behalf of NOOSR.

The Australian Institute of Medical Scientist (AIMS) appreciates the opportunity to provide comment on this consultation paper.

COMMENTS

While the majority of Australian scientists recognise the need for regulation for the, import, supply, manufacture and promotion and export of therapeutic products in Australia and New Zealand, AIMS would like to make comments on some of the issues raised in this consultation paper and to voice some concerns in regard to issues that may need to be clarified or explained in more detail.

The first three parts of the paper outline the purpose of the document and the current regulations in both Australia and New Zealand. AIMS is very optimistic about a Trans-Tasman approach to the regulation, as outlined in part F. One authority with one set of rules and orders that will ensure the highest standards, manufacturing principles and other requirements will guarantee the best possible outcomes for the majority of the end users of the blood. The fact that these regulations will also be applied to imported blood ensures that the blood supplied in both countries will be of the high standard that has come to be expected by the Australian and New Zealand public.

A great many medical scientists, as well as informed members of the public, have considerable concerns regarding the importation of blood into Australia. This fear is not unfounded as the quality and safety of blood in general supply in some countries do not meet the standard of the Australian product, and this is the standard that the Australian public expects. Only recently there have been reports of blood in PNG not being tested for some viral infections as the testing authority did not have the funds to purchase the testing kits. This is particularly worrying in a country that has a very high level of HIV and hepatitis infection.   The restricting of importation to only a few holders of a product licence issued by the Authority is a very good recommendation and safeguard.

There is also concern about the export of blood. Blood in all forms is always in very short supply in Australia. Some questions need to be answered and clarified. Is the Authority making some provision for the restriction of export? Will the Authority allow export only when the Australian and New Zealand stocks are at an above adequate level? Will licence holders be restricted to maintaining above adequate stock levels before exporting blood to other countries? Will export-only blood be subject to higher or lower standards than that manufactured in Australia and New Zealand for local use? It would be a disaster to the health of many Australian and New Zealanders if blood were to be exported by licence holders for profit at the expense of those in need in Australia and New Zealand. Such a practice could be detrimental to the health and well being of some of the citizens of both countries.

It is also excellent to see that blood will be included in the new category of “Biologicals” emphasising the fact that blood is a tissue and that related products are indeed derived from this living tissue.

While the paper is very comprehensive and explains most terms used in the paper with great detail the clarification of the term “Blood kits” (Part F) would be appreciated, as this was not adequately explained  anywhere in the document.

Another concern is the advertising of blood which appears at odds with the current  Australian guidelines for the appropriate use of blood, such as red cells, platelets and fresh frozen plasma. The type of advertising that is to be permitted has not been outlined.

Medical scientists practising in the transfusion medicine field will approve of the Authority’s ability “to impose requirements with respect to the information to be provided in product information documents and consumer information documents”. This could be taken one step further with the requirement of evidence that the consumer has been provided with this documentation prior to consenting to the administration of blood.

The adverse events reporting, recalls, exemptions from the standards and licensing are also outlined in full detail along with the transition provisions which also appear adequate and should in no way interrupt the supply of blood in either country. The only comment is that at one stage the transition period is given as three years from the commencement date of the joint scheme (page 37) and later (on page 41) as a two year transition period.

In conclusion, as the document states, there are to be no changes to the level of regulation in relation to blood;  but these regulations will be administered differently under the combined authority, the new ANZTPA.

Except for the issues and comments mentioned above the document appears to fulfil the purpose for which it was compiled.

Approved by AIMS National Executive 7 December 2006