I am very pleased, a Chathaoirligh, to bring the 1992 Bill to this House. I have to doubt that we will have an enlightened and constructive debate and I look forward to sharing my thoughts with Senators on this important health issue.
The Senators are, of course, aware that the Bill passed all Stages in the Dáil last week. I listened to some incisive and interesting contributions from a range of speakers. Senators will also be aware that in the Dáil I accepted amendments on Committee Stage which, I was happy to acknowledge, were of added value. I also introduced my own amendments in the light of the contributions and comments from Deputies from all parties.
I am pleased, therefore, to commend this Bill to the Seanad. I regret that the debate will, of necessity, be briefer than some Senators may wish. I feel, however, that a number of the issues which Senators may have wished to address will already have been covered during consideration of the Bill in the Dáil and for this reason we have an opportunity today to consider wider issues of a public health nature.
I hardly need to remind the House of the reasons the Bill is before it today. As I outlined in the Dáil last week, it is necessary for public health reasons, as a means of tackling the problem of sexually transmissible diseases, in particular HIV/AIDS which was recognised as a specific entity within the last ten years and it was only in 1985 that laboratory testing for the HIV virus became possible. There are a number of well recognised risk factors associated with the spread of the disease of which the two most common in Ireland are intravenous drug abuse and unprotected sexual intercourse with an infected partner.
Over the past number of years almost 1,250 people have tested positive for the HIV virus in this country; 276 people have developed full blown AIDS according to the internationally accepted definition and 114 people have died. It is very probable, indeed almost certain, that the pool of infection in this country is larger than that reflected in those official statistics. For a variety of reasons, a number of people who have engaged in high risk behaviour do not come forward for testing. In addition, because of the international mobility of people, particularly between here and the UK, people who will have had positive tests in other countries and are now resident in this country may not feature in the official statistics.
It is of paramount importance that the spread of the HIV infection is curtailed. Practical measures need to be taken to prevent the spread of the disease. It is universally recognised that a good quality condom, properly used, provides significant protection against the transmission of the virus. The wider availability of this protective measure must be seen, therefore, as a practical and sensible contribution to the prevention of its spread.
Other sexually transmitted diseases are on the increase too. The network of sexually transmitted disease clinics set up over the past few years in areas such as Dublin, Cork, Galway and Limerick report an increasing number, particularly of young people, using their services for advice, counselling, diagnosis and treatment. Between 1986 and 1990, notification to the Department of Health of STDs has shown a 45 per cent increase. While many STD infections, unlike HIV/AIDS, are amenable to treatment and cure, diseases such as gonorrhoea can have devastating long term effects such as sterility and infertility and are, therefore, not only a cause for public health concern but a source of tragedy and despair for many individuals and couples.
From a purely medical and public health point of view, therefore, the prevention of transmission of these diseases is a matter of serious concern, not only to my Department but to the wider community. The wider availability of condoms, coupled of course with educational activities, has a major role to play in this endeavour.
The Bill also updates to a very considerable extent many of the provisions of the Health (Family Planning) Act, 1979, which itself was amended by the Health (Family Planning) (Amendment) Act, 1985.
The Health (Family Planning) Act 1979 made provision for family planning services with a view to ensuring that contraceptives were available for the purpose, bona fide, of family planning or for adequate medical reasons. It provided that contraceptives might only be sold by pharmaceutical chemists, or chemists and druggists at chemists' shops. A prescription or authorisation from a registered medical practitioner was required for all purchases of contraceptives. It provided for the regulation and control of the sale, importation, manufacture, advertisement and display of contraceptives and other matters, such as the provision of grants for research, offences, penalties, etc.
Regulations made in 1980 required health boards to make available a family planning service and indicated the requirements to be met in relation to family planning services provided by other bodies. They dealt with the issuing of prescriptions and authorisations of contraceptives, their importation and their advertising and display.
The Health (Family Planning) (Amendment) Act, 1985 made a limited number of amendments to the Principal Act. It extended the right to sell contraceptives to registered medical practitioners, employees of health boards, family planning clinics providing services with the Minister's consent and hospitals providing maternity services or services for the treatment of sexually transmitted diseases. Such persons were enabled to sell contraceptive sheaths or spermicides to a person over the age of 18 years with a prescription or authorisation.
Under the Programme for Economic and Social Progress, it was agreed that the operation of the family planning services would be kept under review. In view of this and the significant rise in the incidence of sexually transmissible diseases and of the incidence of AIDS, in 1991 the Government drafted legislation to provide for greater availability of condoms while at the same time respecting the concerns of many groups and individuals, not least parents.
This led to the publication of the Health (Family Planning) (Amendment) Bill in July last year. This Bill provided for (i) an increase in the range of outlets permitted to sell condoms and certain spermicidal preparations; (ii) a reduction in the age limit at which persons could buy condoms and certain spermicides, without prescription, from 18 years to 17 years; and (iii) the removal of the anomaly whereby pharmacies which were limited companies were legally prohibited from selling contraceptives. It provided that condoms could be sold without prescription or authorisation provided that: (i) the purchaser was over the age of 17 years; (ii) the vendor was over the age of 18 years; (iii) the sale was not by way of vending machine; (iv) the sale was either from one of the existing approved outlets selling all contraceptives, that is pharmacies, family planning clinics, hospitals, etc., or from a premises registered by a health board.
The Bill provided that if, on the application of an owner or occupier of a premises, a health board were satisfied as to the suitability of the premises for the sale of condoms and certain spermicides, they could approve the premises for such sales. It also provided that each health board would be required to establish and maintain a register of such premises.
Where a person was convicted of an offence under the Bill, or where the health board considered that his premises were no longer suitable for the sale of condoms and certain spermicides, they could withdraw their approval and remove his name from the register.
As the House will be aware, I have always had a particular interest in family planning services. As a general practitioner I can safely claim to be more familiar than many other people with the concerns, anxieties and problems experienced by couples in this very sensitive and personal area of their lives. Individuals have concerns on religious and moral grounds as well as in the purely physical domain. Communication and understanding between couples and with their general practitioner or family planning professional, are important aspects of the issue. The question of family planning and contraception is complex and highly personal. It may sometimes appear to involve a mere purchase or a prescription but, of course, life is rarely that simple and straightforward. Individuals and couples are frequently concerned or uneasy about the method of family planning which they are using and need a professional but sympathetic ear.
For these reasons I was very much struck, as a practitioner, with the positive elements of the 1979 Family Planning Act, which, over a decade ago, provided for a general approach to the issue which clearly required not only the regulation of the supply of devices, etc., but also for the provision of advices, information and consultation with regard to family planning services. Such advisory services are as relevant today and, in fact, I moved an amendment in the Dáil last week which empowers the Minister for Health to make regulations for the provision of comprehensive family planning services by health boards or other organisations.
Naturally, in my consideration of the family planning legislation, including the Bill which was introduced in 1991, I felt a number of matters needed to be repealed, updated, or amended in a number of ways. As we go through the 1992 Bill in detail I will signal where such changes are being made.
However, at this stage I will just refer briefly to one aspect of the 1991 Bill which attracted considerable attention last year; that was the role proposed for the health boards. The Bill provided that condoms and certain spermicides could be sold without prescription or authorisation provided that the purchaser was over the age of 17 years; the vendor was over the age of 18 years; the sale was not by way of vending machine; the sale took place in the usual premises, chemists shops, from doctors, family planning clinics etc. or in premises registered by a health board.
If, on the application of the owner or occupier, a health board were satisfied as to the suitability of premises for the sale of condoms and certain spermicides, they would approve the premises. Each health board would have been required to establish and maintain a register of premises approved for the sale of condoms and certain spermicides. Where a person was convicted of an offence under the Bill, or where the health board considered that his premises were no longer suitable for the sale of condoms and certain spermicides they could withdraw their approval and remove his name from the register.
I felt that such a role was not appropriate for the health boards. I could not see the need to establish an elaborate registration system for the sale of non-medical items. I also felt that it would have placed perhaps an unfair burden on health boards in trying to reach consensus on what constituted appropriate outlets for the sale of condoms. Rather, I thought, the Bill should spell out clearly where condoms could be sold. An unambiguous statement to this effect would remove any doubt in the minds of health boards or the public as to the legal outlets. Persons found in breach of the Act can be prosecuted in the normal way.
I would now like to take the House through the provisions of the Bill. Section 1 states that the reference in the Act to the Principal Act means the Health (Family Planning) Act, 1979. Section 2 of the Bill amends the definition of contraceptive.
The 1979 Act contained the following definition:
"contraceptive" means any appliance, instrument, drug, preparation or thing designed, prepared or intended to prevent pregnancy resulting from sexual intercourse between human beings.
This definition has been taken from the Criminal Law Amendment Act, 1935.
The proposed new definition in effect, limits contraceptives for the purpose of control under family planning legislation, to condoms, diaphragms and any other non-medical, non-pharmacological appliances. The new definition of contraceptive specifically includes contraceptive sheaths or condoms which had not been specifically included in the definition of the 1979 Act.
The definition of contraceptive will exclude oral contraceptives such as "the Pill" and spermicides which will be subject to the controls over medicinal preparations under the Health Acts. The removal of spermicides from the definition of contraceptive was one of the issues which gave rise to a number of queries during the Dáil debates.
The definition of "contraceptive" in section 2 of the Bill removes spermicides from the provisions of the Bill and transfers these totally to the controls over medicinal products under the Health Acts, 1947-1970. These controls are operated by the Department of Health, in conjunction with the National Drugs Advisory Board. This does not mean, however, that spermicidal preparations will now be subject to a more rigorous regime of control than heretofore and thus more difficult to obtain. It is possible to obtain certain medicinal preparations, without prescription, through non-pharmacy retail outlets, and, subject to the outcome of a review over spermicidal preparations currently being undertaken by the NDAB, spermicidal preparations will be available through outlets considered appropriate by the board. Irrespective of any requirements, therefore, imposed by the family planning legislation, the requirements of the NDAB would be paramount.
The primary consideration, however, was to confine the provision of the Act through section 2 of the Bill to contraceptive devices only and transfer contraceptives with a medical dimension to the more relevant medicines legislation.
Section 3 is a new section I moved in the Dáil last week and I will refer to it in detail later.
Section 4 sets out the list of persons who may sell all types of contraceptives; in effect, condoms, diaphragms, etc. It repeals section 4 of the Health (Family Planning) Act, 1979 and the Health (Family Planning) (Amendment) Act, 1985, in its entirety. It repeals some of the provisions contained in section 4 of the 1979 Act and in the 1985 Amendment Act.
Section 4 (1) provides, in general terms, that: a person may not sell contraceptives unless:
(a) the sale is in accordance with regulations;
(b) (i) (I) the vendor is a pharmacist or a limited company pharmacy or a Licentiate of Apothecaries Hall and the same is made at the place where he keeps open shop; or
(II) the vendor is a registered medical practitioner and the sale is made where he ordinarily carries out his professional duties; or
(III) the person is an employee of a health board, acting as such and the sale is made at a health institution; or
(IV) the person is the servant or agent of a family planning service and the sale is made where that service is being made available, or
(V) the person is an employee of a hospital and the sale is made at the hospital; and
(VI) the purchaser is over 17 years of age or is married or is named by a doctor in a prescription.
The provision of the 1979 Act whereby a doctor had to indicate on a prescription that a contraceptive was required, bona fide, for the purposes of family planning or for adequate medical reasons is being dropped in the Bill. I felt this is unnecessary at this age and I know that it is unacceptable to doctors.
Sale may also be effected by a licensed importer or manufacturer where it is being made to one of the persons which I have listed.
Section 4 (2) provides that contraceptives may be supplied only by way of sale in accordance with the terms of the Act except where supply otherwise is prescribed by regulations.
Senators will be aware that the 1979 Act did not permit the supply of contraceptives free of charge. It was not considered appropriate, or desirable presumably, at that time. Obviously times have changed and it is important particularly in view of the dangers posed to society through the spread of AIDS, that contraceptives, and obviously condoms in particular, can be given out free of charge, as appropriate. This subsection, therefore, empowers the Minister for Health to introduce regulations governing such situations. I would have in mind, for example, the supply of free condoms to, perhaps, certain drug users and persons who are HIV positive.
Under section 4 (3) it will be illegal to supply contraceptives which do not meet standards which the Minister may lay down. This is a very important provision which was not in the 1991 Bill. If we are to make condoms more widely available we must ensure that the public are provided only with quality products. There is no EC standard for condoms as yet, and I will, therefore, be looking at what needs to be done by way of regulation to ensure that condoms of a suitable quality only are available in this country.
It will be an offence to contravene section 4 of the Act. Section 4 (5) provides for the repeal of section 4 of the 1979 Act and all of the 1985 Act.
It is in section 4 that we find the first reference to age in the Bill. Section 4 (1) (b) (ii) provides that a person may buy condoms without prescription if over 17 years or married. The 1985 Act provided that condoms and spermicides could be bought without prescription by persons over 18 years of age. It excluded young married couples, that is under 18 years of age, from obtaining them without prescription. The 1991 Bill would have reduced the age of the purchaser to 17 years, as in this Bill, but would not have permitted young married couples to obtain contraceptives without the prescription or authorisation of a doctor.
I do not consider it appropriate that married couples should seek a prescription for non-medical items which they need for contraceptive purposes. It is an unnecessary intrusion into their married life and, therefore, I have provided that they should be treated as though they are mature adults, that is over 17 years.
Section 5 of the Bill covers the supply of condoms only. Subsection (1) (a) provides that condoms will be available everywhere other than from the excluded outlets which I will list, to persons who are married or over 17 years.
Subsection (1) (b) prohibits the sale of condoms from vending machines; mobile outlets; street vendors; schools, youth clubs or sports centres catering for persons under 17 years of age, or from any other place and in any manner except in accordance with regulations which may be made by the Minister for Health.
Subsection (2) provides that condoms may not be supplied in any place which is not under the supervision of a person over the age of 17 years. Subsection (3) provides that it shall be an offence to supply condoms in a manner not in keeping with the Act. Subsection (4) defines "sports centre" for the purposes of this legislation as being "any premises purpose-built or adapted for the practice or playing of active sports".
Senators will be aware that the 1991 Bill specifically excluded vending machines only. However, it provided a registration function for health boards whereby the boards would approve premises as being suitable for the sale of condoms. I felt that by specifying a clear list of excluded outlets the interpretation of this Bill should be less cumbersome. With regard to the exclusion of vending machines for purposes of sale, I have stated my reasons for this in the Dáil.
The Bill represents a significant liberalisation of outlets through which condoms may be sold and, by extension, greater access to condoms for those who require them. By prohibiting sale by way of vending machine it balances such wider access with the desire of parents to have some objective level of supervision over the availability of condoms where young persons are concerned.
Section 5 (2) provides that condoms may only be sold in a place under the supervision of a person over 17 years of age. This is intended to ensure a certain element of control and supervision of supply. The 1991 Bill provided that a sale could only be effected by a person over 18 years of age although condoms could be bought by a person over 17 years of age. I felt that there was a certain inconsistency in this approach and I have, therefore, reduced the age of the vendor to 17 years.
Section 6 relates to importers and manufacturers. Subsection (1) provides that a person shall be entitled to sell condoms to persons over 17 years for resale in a manner not in conflict with the Act. This provision permits wholesalers, importers and manufacturers to purchase and resell condoms to permitted outlets. Under section 6 of the 1979 Act licensed manufacturers of contraceptives are not permitted to export. There is no good reason for continuing this situation which could restrain the activities of some pharmaceutical companies and subsection (2) provides, therefore, that a person holding a manufacturer's licence under section 6 of the Principal Act shall be entitled to export contraceptives to which the licence relates.
I do not consider it necessary to continue to require importers and/or manufacturers of condoms to obtain licences. Section 5 of the 1979 Act requires importers of contraceptives to have a licence from the Minister of Health. In future, therefore, the provisions of sections 5 and 6 will not apply to importers or manufacturers of condoms.
Section 7 provides for the inclusion of medical contraceptives in the definition of medical preparations. The Health Act, 1947, contains the definition of "medical preparation" which is widely used in respect of the control of advertising, sale, etc., of drugs and medicines. This amendment to the definition of "medical preparation" will bring the contraceptive pill and spermicidal preparations within the scope of medical preparations, which is generally the position in other EC countries. The "pill" will no longer be covered by the family planning Acts and "contraceptive" has been redefined in section 2 to take account of the new situation.
I would like, at this stage, to draw Senators' attention to two sections of the Bill which are consequent on amendments agreed in the Dáil last week. Section 8 is a new section which is inserted on foot of an amendment which I moved on Thursday last in the Dáil. This section repeals section 2 and 3 of the 1979 Act. Section 1 provided for the general duty of the Minister and section 3 catered for the provision of family planning services by health boards or persons other than health boards.
The new section 8 retains the positive features of sections 2 and 3 of the 1979 Act in that it requires the Minister to secure the orderly organisation of comprehensive family planning services and enables him to provide for the making available of such services by health boards or other organisations such as family planning clinics. It does not emphasise any particular types of family planning service whereas the 1979 Act distinguished between what were described then as "natural family planning services" and "family planning services, not being exclusively services which did not involve the use of contraceptives". I will be looking at the need to make regulations under this new section 8. The Minister is empowered to do so, in subsection 8 (2).
Section 3 is a new section, further to the debate in the Dáil last week. The section deletes certain words in section 9 of the 1979 Act, the effect of which is that the Minister for Health may grant aid research into any method of family planning. The 1979 Act confined the Minister to funding research into methods of family planning that did not involve the use of contraceptives. This is patently inappropriate today.
Section 9 (1) is a technical section giving the short Title of the Act and is a normal provision. Subsection (2) provides that the Principal Act and this Act may be cited together and is also a usual provision where there is an earlier Act concerning the same matter. Subsection (3) provides that the Principal Act and this Act will be construed together. Where, for example, provision has been made in the 1979 Act for specific activities or where certain words have been defined in the earlier Act, it is not necessary to repeat these activities or definitions in this Act.
I hope this Bill will meet with the approval of the House. In conclusion, I will refer briefly to those areas in which I will be introducing regulations under the Act. First, as I have already mentioned, I will be introducing regulations under section 4 (2) to provide for the supply of contraceptives free of charge in certain circumstances. Second, under section 4 (3), I will be looking at the question of introducing standards for contraceptives. Third, in the light of the new section 8, I will be considering what regulations are required with regard to the making available by health boards or other bodies of a comprehensive family planning service.
Finally, I would like to inform the House that I will be amending regulations at present in force under the 1979 Act with regard to the advertising and display of contraceptives. Section 7 of the 1979 Act provided that a person could not take part in, or procure, the publication of an advertisement or notice in relation to contraception or contraceptives except in accordance with regulations. The 1980 regulations provided that publication or display should either be: (a) related to family planning services authorised under the Act or, (b) is reasonably necessary for the purposes of informing persons providing family planning services under the Act; registered medical practitioners; registered chemists and druggists; registered nurses; trainee doctors, chemists or nurses and (c) where the publication or display is arranged by or on behalf of the Minister.
It is fairly obvious that these provisions are now out of date. They were framed at a time when acceptability of advertising and displaying condoms, for example, was quite different. Today we are talking about a serious public health issue. We want to encourage young people and all who are sexually active and may be at risk to take sensible precautions against both sexually transmissible diseases and unwanted pregnancies. This is important. The new outlets should be able to display condoms as should the traditional outlets, many of which have had concerns about advertising and displaying contraceptives for some time. I will be looking at the changes which should be made to the current regulations to bring them into line with the provisions in the Bill.
In conclusion, a Chathaoirligh, I hope I have explained the Bill in sufficient detail and I commend it to the House.