John Dennehy (Cork South Central, Fianna Fail)

I welcome the opportunity to contribute on the Bill. We often tend to describe Bills as coming to the House not before time. It is appropriate to say the same in this instance. It must be hard for the public to comprehend that in the process we are repealing Acts related to the profession which date back to 1790 and 1870. This is the first major overhaul of the regulation of pharmacies in 130 years. I accept an effort was made in 1962 to overhaul the sector, but it was not far-reaching.

This legislation will deal with the modern reality of pharmacy services and hopefully will prove a tonic for a sector ailing from the lack of regular diagnosis over a long period. Many of our constituents have raised complaints and issues with us that should have been dealt with. This is the 21st century and updating of legislation dating back two centuries is long overdue. The Bill will underpin the long-term health of the sector. It sets out to properly regulate the pharmacy sector. Among other things, it provides for the recognition of some foreign education pharmacists and the removal of restrictions on them from owning or managing a pharmacy outlet less than three years old.

The Bill will open up the sector and allow for more competition in what tends to be a monopolist situation. It will mean, in particular, that Irish graduates who studied and gained experience abroad will now be catered for at home. This is a step forward. Many of us are aware of individuals who had to study abroad who find it difficult to start up or become involved in business here as a result. While the changes are necessary, as with all medicines, we need to read the label carefully. No doubt some people may find some of what is involved hard to swallow, but we must deal with the issues.

I acknowledge the good work of the Pharmaceutical Society of Ireland and the role it played in helping to keep up standards in the industry. I will come to the issue of possible conflicts and monopolies, but we should recognise how well the industry has been run, notwithstanding the complaints we may have heard. The PSI is the regulatory body for the industry and maintains discipline in the area. It has done significant work in that regard. There is concern that the PSI is also a representative body and that this could raise a potential conflict. I am sure the Minister will bear this in mind in the debate and on Committee Stage.

We have seen rapid change in other areas, for example, politics, the Garda and the legal and medical professions. These are all caught up in the thinking that self-regulation is no longer an option and separation of regulative and representative aspects of these areas is taking place. Most people subscribe to this concept of change. Relations were difficult and incestuous and changing the situation is difficult. There is no benefit in rehashing the cases that led to the call for change, but they happened across the board, whether in politics, the Garda or the medical area. These cases highlighted the need to get rid of self-regulation.

With such a potential for a major mishap, nobody wants to see in place anything other than the highest standards in all areas of the pharmaceutical business. For that reason, it is important to include in the Bill the issues of competency in the English language and other requirements for qualifying persons. There are some dangers in this regard. It has often been said that only a doctor or chemist can read a doctor's writing, but at least doctors were writing in English. We must be aware of the danger involved with regard to prescriptions and ensure requirements are in place to safeguard patients receiving or filling prescriptions. These requirements can be included without making things difficult for any group in particular.

While welcoming the changes proposed, we must ensure as far as possible that small pharmacies can continue to operate successfully in communities. Often, these outlets, like other local services, provide a service of comfort and advice to customers as well as fulfilling their primary role. Achieving the correct balance should be foremost in our minds. We debated this issue previously when there was a difficulty when some companies were buying existing pharmacies to create more or less a monopoly. There was a danger, until a cap was set, that we would finish up with two or three companies running the whole business.

Without getting into a row on competition, it is important to try to protect small outlets. One way of protecting such businesses is to have proper regulations in place that will encourage small outlets to broaden out and expand business. This is happening. It is a pleasure now to visit most pharmacies as they are well laid out and well run.

As with reform of other sectors, patient safety must be paramount and any proposed changes must be tested in that context. We must consider how changes in a service that is a vital cog in our health infrastructure will affect public confidence, which is crucial. Almost every chemist with experience in a local community service is willing to provide advice to people without charge and do their best to facilitate customers. This service is important as part of health provision and it is important that the public have confidence in this regard. In this respect it is important that we deal with the issue of fitness to practise in as open and transparent a fashion as possible.

The proposals in the Bill, including the review of the fitness to practise regime for the sector, can only benefit the public. Much work was done on this area in committee and regulations are in place to ensure certain material cannot be published etc. While I accept the right of individual practitioners to fair treatment at all times, it is important the public is made aware of the outcome of any hearings. There has been disquiet recently about secrecy in the medical field. Most professional bodies subscribe to the view that it is necessary to be open. It is a case of getting the rules right.

Our registration system will be brought into line with EU best practice and extended to the retail pharmacy business. High standards must be employed when we consider that the retail business is the last filter between the prescription drug makers and takers. There are many questions to be discussed on Committee Stage about whether the Bill covers pharmacists in the industry, regulations, removal of medication from hospitals and so on. There will be a serious outcome if we get this wrong but it is a welcome part of the overall change in the health care regime from having 27 different bodies making an input into the service and over 1,000 separate contracts and agreements between health boards.

It is necessary to have a fully-trained pharmacist on the premises at all times. In the past people have suggested that this standard was too high, citing the amount of non-prescription items sold in a pharmacy. That is fine until something goes seriously wrong and there are calls for tighter regulations and inquiries. I read recently that Senator Henry asked whether the regulations should cover trainees. They probably should so that trainees learn best practice from the outset. The Minister will consider these points on Committee Stage. This legislation achieves the highest standards at the upper level.

Some fear the conflict of interests between those who manufacture, prescribe and, to a lesser extent, dispense drugs. There is concern too about profit margins on some products. More will be done about this on Committee Stage which I welcome. This is of great importance to the health and financial well-being of the general public, as well as to pharmacists. The difference between generic and prescription drugs is so great that a separate monitoring regime is needed. The talks between the Government and some major pharmaceutical companies has led to significant savings, and the potential exists for much more if properly handled. The general practitioner is the first in line, being the prescriber. All sectors, however, need to work on this aspect of the business. We have seen comparative figures for the products in Spain and elsewhere and heard arguments about where companies are based and their need for research and development. It is a difficult area, involving large sums of money. The companies' practice of sponsoring golf classics and taking people on trips needs to be examined and kept in check because the State pays too much for this activity.

The Pharmaceutical Society of Ireland has largely welcomed the publication of the Bill, particularly the updating of the regulatory framework, which is hardly surprising given that it repeals 130 years of legislation. There is also concern, however, that the enactment of new legislation can lead to unexpected problems elsewhere. There is a danger we could box ourselves into a corner, for example, section 4 of the competition Bill raises a problem between pharmacists, the Department and others.

I questioned Professor Drumm about this at the Committee of Public Accounts when he indicated the pharmaceutical sector sought legal advice on the issue of talks being held with the various groups and it was found that this was contrary to section 4 of the competition Act. That could have a serious effect on dealings between the Minister and members of the pharmaceutical society.

I am not sure how that can be resolved. We have traditionally conducted discussions with interest groups as we do in the national agreement process. They never like being called trade unions but being a trade unionist I am used to that term. It would be a matter of concern if discussion was no longer possible. They are usually people who are experienced, practical, have been through the mill and are capable of negotiating and discussing their members' interests. That might no longer happen if what I read is correct. I dread to think that it would be necessary to make a separate contract with every pharmacist in the country and that we could not discuss this at any level.

Other Members will raise interesting issues. I have little experience of the pharmacy sector but have a working knowledge of it having chaired health boards three or four times. When this issue arose I met people who have pharmacies and who expressed concern about this issue. Other factors need to be discussed such as contracts and the supply and price of drugs, although they lie outside the scope of Bill. I look forward to the Minister's response and the Committee Stage discussion.

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