Illegally-taken human body parts not in NZ

22 June 2006

Illegally-taken human body parts not in NZ

Initial checks by the Ministry of Health indicate that batches of medical products made from illegally-taken human body parts were not commercially imported into New Zealand.

The Ministry of Health monitors recalls conducted by the United States Food and Drug Administration (FDA) and investigates any issues that may involve New Zealand, says Chief Clinical Advisor Dr Sandy Dawson.

Four recalls were notified by the FDA but only one of these could have involved New Zealand. The recall currently affecting Australia was specific to Australia, the United States and Korea.

Follow-up action identified that the products were not imported into this country.

The Ministry is currently double-checking that products sent to Australia did not find their way to New Zealand.

?We believe the likelihood that any affected batches have been brought into this country is very low but we are double checking with doctors in New Zealand.

?We are not aware of any illegally-removed tissue having been exported to New Zealand.?

The illegally-taken tissue exported to Australia was included in various batches of products including Alloderm, Graft Jacket and Repliform.

Links to the relevant FDA information will be made available on the Medsafe website.

These products are not formally approved for use in New Zealand and so they are not covered by the Medicines Act or regulated by Medsafe.

Doctors are able to import these products directly when they believe there is a clinical need.

When doctors import these products into New Zealand they are not currently required to inform any health authorities about this.

?When a doctor uses an unapproved material on a patient we have no way of knowing what was used, due to current regulatory requirements.?

The Ministry of Health will be writing to District Health Boards, private hospitals and contacting doctors through their colleges and the Medical Council.

?We will be asking them to inform us urgently and contact their patients immediately if they have privately imported the particular batches of these products.?

If any patients have been given tissue from the batches in question they will be advised to undergo blood tests for HIV/Aids, Hepatitis C and syphillis.

New regulations specifically covering tissue will be introduced under proposed new legislation for the first time in New Zealand with the establishment of the Australia New Zealand Therapeutic Products Authority.

The legislation will require such products to be registered before use and for clinicians to report the use of any unregistered medicines, medical devices, cells or tissues to the authority. The use of these products could be tracked if necessary.

Anyone who has had cosmetic or reconstructive surgery in Australia and believes they may have received one of these affected products should contact the surgeon or hospital where they were treated for more information.

If the Ministry of Health becomes aware the affected batches of product have been used in New Zealand we will provide further advice to patients through the specialists and hospitals involved.

ENDS