Vol. 510 No. 5
8 Mrs. T. Ahearn asked the Minister for Health and Children the steps, if any, he proposes to take concerning the dramatic increase in meningococcal meningitis occurring which has resulted in the number of notifications of the disease increasing from 131 in 1990 to 485 in 1998; and the steps, if any, he proposes to take to tackle this problem. [21052/99]
23 Ms Fitzgerald asked the Minister for Health and Children if he will make a statement on the recent facts which have emerged that the incidents of meningococcal disease comprising meningitis and septicaemia is almost five times the European average and is continuing to rise; and if he will make a statement on the matter. [21424/99]
42 Mr. O'Shea asked the Minister for Health and Children the steps, if any, he is taking arising from the recent report showing the incidence of meningitis is almost five times the European average; and if he will make a statement on the matter. [22860/99]
151 Mr. Shatter asked the Minister for Health and Children the steps, if any, he proposes to take concerning the dramatic increase in incidence of meningococcal meningitis which has resulted in the number of notifications of the disease increasing from 131 in 1990 to 485 in 1998; and the steps, if any, he proposes to take to tackle this problem. [23027/99]
I propose to take Questions Nos. 8, 23, 42 and 151 together.
The increased level of notifications of bacterial meningitis and related conditions in recent years is in part attributable to the greatly increased awareness among health professionals and the general public, as well as improved techniques for diagnosis of the condition. Nonetheless, while there continues to be much research in relation to meningitis, it is not fully understood why Ireland experiences such a different pattern of disease from other countries in Europe and elsewhere. It should be noted that, despite the increased incidence of meningitis, there has not been a corresponding increase in mortality from this condition.
The Working Group on Bacterial Meningitis, which was established in 1996 under the chairmanship of my Department's deputy chief medical officer, published its first report in 1997, making a wide range of recommendations on such issues as the surveillance, diagnosis, treatment and prevention of meningitis. In the course of reviewing that report this year, the group found that these recommendations had been extensively implemented by the different interests involved. The group has recently published an updated report and this includes detailed template guidelines on the management of meningitis in the hospital setting. These guidelines are intended to be adapted as considered necessary to meet local circumstances in individual hospitals. The working group is a standing committee and will continue to review the situation and make further recommendations as it considers necessary on the management and prevention of this serious and distressing condition.
On public education, the health boards, in conjunction with voluntary bodies, have conducted extensive educational campaigns on meningococcal disease. There continues to be close liaison between the health boards and the voluntary bodies concerned, principally the Meningitis Research Foundation. The health promotion unit has produced an updated information leaflet and in 1998 a video entitled Meningitis: Prompt Action Saves Lives was produced by the Office for Health Gain in conjunction with the Meningitis Research Foundation. The Irish College of General Practitioners also designates education officers in each health board area who are in a position to assist in the event of an outbreak of meningococcal infection.
A new conjugate vaccine to protect against group C meningococcal disease, which represents about 40 per cent of the disease in Ireland, is shortly expected to become available and planning is under way for its introduction into the primary childhood immunisation programme and for it to be given to older children and young people in a catch-up programme. It is also important that, even after the group C vaccine is introduced, vigilance is maintained, as there will still be a significant risk of people contracting group B disease, which represents about 60 per cent of the cases occurring in Ireland at present. I would like to take this opportunity to emphasise that it is vital that people are familiar with the symptoms of the disease and of the need to seek immediate medical help from a general practitioner or hospital casualty department where they have cause for concern.
Does the Minister agree that the fact we have the highest level of meningitis in Europe is a cause of great concern? Will he indicate when the new group C vaccine will be introduced and the reason for the delay in introducing it in the context of it having already been introduced in the UK?
It is estimated that about ten deaths every year are due to group C infection. Wyeth Pharmaceuticals has developed a new type of group C vaccine which has recently been introduced in the UK. This conjugate vaccine is different from the previous vaccines and is expected to confer prolonged protection against the infection. It requires three doses in infancy and a single dose above 12 months of age. It is intended that the vaccine when licensed should be incorporated into the primary childhood immunisation programme. I have made arrangements in the Estimates for a national immunisation programme as soon as the IMB licences the product.
Why is the Irish Medicines Board taking longer to license the product than its equivalent in the UK? Has the Minister inquired from the board when it will make a decision on the matter? Has he inquired when it is anticipated that a licence will be issued? Given that the vaccine has been introduced in the UK is there any reason it should not be introduced and approved here by the IMB? Will the Minister ask the board to make haste in addressing this issue in the context of the high level of meningitis in the country?
It is wrong to suggest there is any dilatory behaviour on the part of the IMB on this issue. It is important to point out that under the European mutual recognition procedure for medicinal products a manufacturer must first obtain a licence from one country, known as the reference member state, and a procedure can then begin for authorisation of the product for use in other member states. That procedure takes between 90 and 120 days from its beginning to final national consensus. In the case of Ireland the IMB is the statutory licensing authority and it must satisfy itself that the product meets the requirements in relation to such issues as safety and efficacy before a product authorisation is granted. On this basis it is likely the vaccine will be licensed for use here by late February or early March 2000. There is a time lag because of the necessity for the manufacturer to first obtain a licence in one country as a reference state, i.e the UK.
It need not be as late as March.
It is for the IMB to satisfy itself and discharge its responsibilities. There is no question of the IMB not doing so as quickly as possible and with due process. It is not fair to suggest the IMB had the application at the same time as the UK as this is not the case.
Does the Minister accept people will be puzzled when they hear this when one considers that the IMB was very swift in putting St. John's Wort, for example, on prescription ahead of other European countries while we have to wait until February or March of next year before a decision is made on this vaccine, which is of huge significance in protecting children in particular and in saving lives? The IMB depends on the research of pharmaceutical companies and that is the normal procedure. I ask the Minister to explain why it will take so long for the IMB to assess research which is readily available to it.
A totally different procedure relates to the matter raised by the Deputy and I do not have the details with me on that. However, I can get the details for her. The relevant procedure in terms of the vaccine is the European mutual recognition procedure for medicinal products, whereby a manufacturer must first obtain a licence in one country. I think this explains why the product is not contemporaneously licensed in all countries. The first country in which a product authorisation licence is granted is the reference country. I cannot explain to the Deputy the background as to why that is the case, but that is the European requirement and that is what is happening in this case.
The IMB, with a greatly increased workload, has and is doing a very important job in ensuring medicinal products are properly licensed. In the past, parliamentary questions have been tabled asking why the IMB was not doing its job in licensing products. We now have a counter argument in another issue.
It is about priorities.
It is not, in fairness, Deputy. It is a question of dealing with the issues on their merits according to the established procedures which are Europewide in this case.
