Inquiry into Matters Relating to the Safety_of Blood Products in New Zealand Wellington December 1992 3 Department of Health TETARI ORA Mr. J. C. Lovelace Director-General of Health Department of Health Wellington Dear Mr. Lovelace, In accordance with the Terms of Reference of the Inquiry into matters relating to the safety of blood products in New Zealand, we have the honour to present our report. 00, 0 Dr Sue Morey Hon. Stan Rodger Member of the Inquiry Member of the Inquiry WELLINGTON 15 December 1992 EXECUTIVE SUMMARY REPORT OF THE INQUIRY INTO MATTERS RELATING TO THE SAFETY OF BLOOD PRODUCTS IN NEW ZEALAND 1 Issue which led to the Inquiry On 17 November, an article in the "Dominion" newspaper raised concern about the continued supply, after HCV screening was introduced in July 1992, of the blood product Factor IX (Prothrombinex) which was manufactured from blood unscreened for Hepatitis C, resulting in potential risk of Hepatitis C infection for haemophiliacs using Factor IX. 2 Establishment of Inquiry and Tennis of Reference The Director-General by letter dated 23 November 1992 appointed the Inquiry under Section 7 of the Health Act 1956 and Section 90 of the Area Health Boards Act 1983. Dr Sue Morey, Chief Medical Officer, New South Wales Department of Health, Australia and the Honourable Stanley Joseph Rodger, retired Member of Parliament and former Minister of the Crown, were charged as follows: "Now pursuant to section 7 of the Health Act 1956 and section 90 of the Area Health Boards Act 1983 you are appointed and requested to do the following: 1 To determine the circumstances surrounding the continued supply after 1 July 1992 of a blood product which potentially exposed the users of that product to the risk of infection with Hepatitis C; and 2 To investigate what are the responsibilities and functions of the Office of the Minister of Health, the Department of Health, the Blood Transfusion Advisory Committee and the Regional Blood Transfusion Services and how those functions and responsibilities inter- relate in respect of: 2.1 The provision of policy advice to the Minister of Health regarding the risk of infection with Hepatitis C resulting from receipt of fractionated blood products; and 2.2 The facilitation of the efficient and effective and safe acquisition and distribution of fractionated blood products in New Zealand. 3 Report to the Director-General of Health on the results of your inquiry making recommendations as appropriate regarding: 3.1 Any changes to processes for the preparation and submission to the Minister of Health of policy advice relating to blood and blood products; and 3.2 Any changes to the responsibilities and functions between the office of the Minister of Health, the Department of Health, the Blood Transfusion Advisory Committee and the Regional Blood Transfusion Service and their inter-relationships that are necessary to facilitate the acquisition and distribution of blood and blood products in an efficient and effective and safe way (bearing in mind the Governments proposals for the reorganisation of the Blood Transfusion Service). 3 Procedure Adopted b y the Inquiry 3.1 The Inquiry reviewed the functions and responsibilities of the Office of the Minister of Health, the Department of Health (including changes arising from departmental restructuring), the Blood Transfusion Advisory Committee and the Regional Blood Transfusion Services. The roles and inter-related responsibilities of the Communicable Disease Control Advisory Committee and the Medicines Adverse Reactions Committee were also considered. 3.2 The Inquiry examined departmental files for all relevant correspondence, background papers and briefing papers to Ministers, the Minutes of the relevant advisory committees and interviewed departmental and ministerial office staff, in order to establish a chronology of events. 3.3 A number of interviews were held and submissions were received from a variety of organisations and individuals. 4 General Observations Funding for screening of donated blood for Hepatitis C was provided from 1 July 1992. As a result of timing of approval and time required for the tendering process and implementation, screening of blood for Hepatitis C was not in place throughout the country until 27 July 1992. Because the time difference between plasma collection and product return for Factors VIII and IX is up to nine months, from 1 July until 30 November 1992, blood products supplied for clinical use in patients with haemophilia continued to be that made from blood unscreened for Hepatitis C. In the case of patients with Haemophilia A, as the products had been subjected to high heat treatment (80°C), any Hepatitis C virus in the plasma used to make the product would have been inactivated. However, for patients with Haemophilia B (Factor IX deficiency) there was no - readily available product which could guarantee absence of potential exposure to the Hepatitis C virus. Neither the Minister of Health nor senior officers of the Department of Health had been specifically alerted to the fact that, despite introduction of screening of blood donations, there was a small group of patients, ie those with Factor IX deficiency, who had not been previously infected with Hepatitis C (a total of between 10 and 15 patients) who were potentially exposed to the virus if they received Factor IX. This is clearly a small subsection of a very vulnerable group of patients, already carrying a significant burden of illness, and they warrant special attention. Even if they had been specifically alerted to the fact that blood products derived from blood unscreened for Hepatitis C were still in use, no clearly defined and completely satisfactory alternative was available. High heat treated Factor IX (Prothrombinex H-T, PTX H-T) has not been available to either Australian or New Zealand patients because it is a new product which has not yet been approved by the Australian Drug Evaluation Committee, and there is a prohibition on the export of products which are not licensed. (This unlicensed product was however made available to New Zealand on 30 November 1992 at the request of the New Zealand Department of Health). While the letter of 31 July 1992 to the Minister of Health written by Dr E W Berry on behalf of the Medical Advisory Panel of the New Zealand Haemophilia Society referred to the potential 2 problem for Factor IX deficient haemophiliacs associated with the lack of PTX-HT, the primary purpose of the letter was to request funding to import products from overseas. The Ministers reply of 4 September 1992 referred to the fact that Area Health Boards have the responsibility to provide services for the health needs of the people of their region. While any Area Health Board has the ability to buy commercial products which have been high heat treated (or equivalent new products) from overseas, the fact that these products are derived from unknown plasma which may contain unrecognised viruses is a cause for concern in scientific communities. There is no doubt that much of the media attention to this issue has been inaccurate and misleading and has led to unnecessary anxiety for the New Zealand public. Nevertheless, the circumstances surrounding events subsequent to 1 July 1992 can only be placed in perspective by acknowledging that there has been widespread community concern and debate regarding testing of donated blood for Hepatitis C in New Zealand since early 1990. The Blood Transfusion Advisory Committee advised the Department of Health in June 1990 and the Communicable Disease Control Advisory Committee advised the Minister of Health in August 1990 that screening of donated blood for Hepatitis C should be introduced. The matter was refel-red to the Department of Health which commissioned a number of cost-effectiveness studies. The Department was apparently concerned that the sensitivity and specificity of the available test were not sufficiently high for this to be introduced at a time of significant budgetary problems for Area Health Boards. Approval in principle for the provision of central funding for the introduction of Hepatitis C screening was given by the Minister of Health on 30 July 1991. Additional funds were sought through normal budgetary processes, but this application for funding was rejected, with approval of funding only recommended if funding was available from reprioritisation within the Health Budget. Funds were withheld centrally from AHB Budgets to allow screening to commence in the 1992-93 financial year. This two year delay was a cause of considerable concern to transfusion services, clinicians and the general community, and was the subject of ongoing representations to the Minister and the Department. It is not difficult to see how the larger group of transfusion recipients in general detracted attention from the greater risk posed to the much smaller number of potential recipients of unscreened, non high heat treated Factor IX . At no time was it clearly articulated that even the second generation screening test was only 98% sensitive, and would not detect 2 of every 100 infected donors. • Therefore, when up to 6,000 donations were pooled to make one batch of Factor IX, given the estimated prevalence of 0.31% of Hepatitis C in the donor population, 33% of batches are likely to contain Hepatitis C virus. In the absence of super heat treatment, over a period of time, all recipients of Factor IX are likely to become infected. It is obvious that the complexities of the problem are unlikely to be recognised by those without a medical and scientific background. The fact that the Department of Health was undergoing a number of major restructures during the period and that there was no medical or epidemiological input from within the Department at decision making level, no doubt contributed to the delay in introducing screening.