Howlin should quit over his role in hepatitis C scandal

BRENDAN Howlin, the present Minister for the Environment, bears some of the Ministerial responsibility for the mishandling of the hepatitis C crisis. He was Minister for Health in February, 1994, when the crisis broke and he has not been held accountable for his actions of that time. But first let us acknowledge that which he did right.

On Thursday, February 17th, 1994, the Blood Transfusion Service Board (BTSB) informed the Department of Health that there was a clear link between a 1977 plasma donor for "Human Immunoglobulin anti-D" and the occurrence of hepatitis C. Brendan Howlin is to be credited with going immediately, first to order the recall of all the infected anti-D from maternity hospitals around the State, then to make a public statement over the discovery and, finally, instituting swiftly a screening programme.

He was criticised by the Irish College of General Practitioners (ICGP) for not informing GPs of the infection and of the screening programme, in advance of informing the public. Fine Gael accused him of "scare-mongering".

The expert group, chaired by Miriam Hederman O'Brien concluded: "We consider that the Department of Health and the BTSB took the correct decision in making the incident public immediately. Any significant delay, while general practitioners or other health professionals were being informed, could have led to widespread concern, since it is very likely that some of the details would have become public in advance of a formal announcement." So far, so good. But two things then happened, which, in the context of the seriousness of the issues at stake, are quite breath-taking.

The first concerns the issuing of what is known as a "product authorisation".

Product authorisations became required for blood products, including anti-D, from April 1st, 1983, under an EC regulation of 1975.

Clearly, the point of such product authorisations was to provide a safety check for blood products. This left the Department of Health and the Minister for Health as second guarantors to the reliability of such products.

But by February, 1994, when the hepatitis C crisis broke, the Minister and the Department of Health appear to have entirely abnegated their role as second guarantors of all kinds of medical preparations, including blood products. No product authorisation had been issued for anti-D since April 1st, 1988. That in itself may raise questions about the actions of all of those who have been Minister for Health from April 1st, 1988: Rory O'Hanlon, Dr John O'Connell, Mary O'Rourke and Brendan Howlin himself.

But there is worse. Six days after the Department of Health was notified of the hepatitis C link with anti-D, Mr Howlin's Department gave retrospective product authorisation for anti-D for the period April 1st, 1988, to March 31st, 1993. Note, this was done on February 23rd, 1994, while the Minister and the Department of Health had been informed of the hepatitis C link six days previously, on February 17th, 1994.

A spokesperson for Brendan Howlin says Brendan Howl in had no knowledge of this retrospective product authorisation at the time or any knowledge that anti-D was being sold without product authorisation since 1988. When he had become Minister in early 1993 he had signed a raft of delegation orders of which this was one.

FURTHERMORE, it is pointed out, the area of product authorisation was in a mess at the time because of a huge backlog at the National Drugs Advisory Board (NDAB) it had a backlog of 8,000 files on hand in early 1994. Because of this the required specialist advice on medical preparations were not available to the Department at the time.

Brendan Howl in, it is said in his favour, had set about reconstituting the NDAB and this was brought about in legislation passed in 1995.

This is to the credit of Brendan Howlin but it does not exonerate Brendan Howlin.

The fact was that he and his predecessors since 1988 were the second guarantors of the safety of medical preparations, including anti-D.

In addition, the granting of retrospective product authorisation to a product then known to the Minister and the Department as poisonous was shameful. The denial of knowledge does not remove responsibility. The second charge against Brendan Howlin is even more grave.

While he acted with commendable swiftness in requesting the withdrawal of the infected product, in making the public immediately aware of the crisis and in instituting a screening programme forthwith, he failed in a crucial responsibility.

Given the lethal nature of the anti-D product, the general responsibility which a Minister for Health has for the physical well-being of citizens and his special role as the second guarantor of the reliability of blood products, he had a crucial duty to ensure that the infected product was in fact withdrawn.

This was not done. At least eight doses of infected anti-D were administered after February, 1994, some doses administered some several months later. This was in part because Brendan Howlin failed in his special duty to ensure that all such product was withdrawn.

MINISTERS are technically and legally responsible for everything that happens in their Departments. This is what leads them to refer so irritatingly and so presumptuously to their Departments as my Department". The scope of such responsibility is, in reality, far too wide. But Ministers can and must be held responsible for the major happenings within their Departments and what happened in relation to the hepatitis C crisis certainly falls into this category.

Certainly, the issuing of retrospective product authorisations was not something which should have happened without direct Ministerial involvement. The granting of the retrospective authorisation six days after the Minister and the Department were informed of the product's lethal nature is not something that can be shrugged off on the grounds of delegated authority.

Even less so can the failure to ensure that all the infected product was withdrawn from maternity hospitals be shuffled off to a Departmental oversight or agency inefficiency. This is especially so as there was a means of checking how many doses there were in each hospital at any one time.

Brendan Howlin should be the first politician to walk the plank of accountability over this appalling scandal.