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Pharmaceutical Regulations
4th March 2002

At the moment one would need to be a centipede to have a foot in every corner there is so much going on. There are many special committees or task forces in the Department of Health and Children, not to mind in other departments, some of which are extremely important and one doesn't hear much about what is going on in them until they report.

Sometimes decisions are made, indeed even before the committees make any reports at all. This happened with the decision to revoke the 1996 Pharmacy Contractor Regulations recently. The Minister for Health and Children set up a special committee last September to review the regulations but one wonders why the committee was set up at all if the decision to scrap the 1996 agreement was made before it reported.

I asked in an adjournment debate why this had happened and got the reply that the retail pharmaceutical trade had not been deregulated which is correct really seeing that all the Acts and Regulations to open or run a pharmacy have not been changed, but the revocation of the 1996 arrangement was precipitive to say the least of it.

The Minister explained his reasons for revoking the 1996 Regulations as follows:-

"During ongoing legal challenges to the Regulations, the Minister sought advice from the Attorney General's Office on the legal basis of the Regulations. The advice received concluded that the Regulations were ultra vires. Given that advice, he could neither defend the Regulations in court nor make settlements under them. Therefore, he revoked the Regulations on 31.1.02.

"The net effect of the revocation of the 1996 Regulations is that there are no restrictions on the granting of new health board contracts in terms of location, population or viability of existing pharmacies. The revocation does not affect the operation of the community pharmacy scheme, and existing pharmacy contracts still stand.

"The Minister has consistently supported a regulatory framework for community pharmacy services, as for the health services in general. The Department has spent 4 years and a considerable amount of money defending this framework in court and in other quarters. While it was not possible to continue doing so, the decision to revoke the Regulations was not one which was taken lightly."

The Minister explained that the Pharmacy Review Group is examining, among other things, issues raised in the OECD Report in relation to the consent procedure for granting community pharmacy contracts. The revocation of the 1996 Regulations resulted from legal factors, and did not involve any of the issues that the Group was set up to examine.

The argument as to whether deregulation will lower prices is one that goes on and on. One thing I do know is that in America spending on prescription drugs is the fastest growing component of the health care budget. Some consider that this is directly related to the new guidelines issued in 1997 by the Food and Drug Administration (FDA) regarding advertising to consumers through electronic media. Apparently there has been a flood of direct to consumer advertising by the pharmaceutical companies since then especially on television. Advertisements for anti-inflammatory, anti-ulcer, anti-histamine and anti-depressant drugs being the most common. Viagra is well advertised, too, as are some weight loss promoters.

Spending on promotions to health care professionals in the U.S. is still important but has gone down. It would appear that direct to consumer advertising is seen as the best way to promote high priced drugs.

We have a very low consumption of pharmaceutical products in this country. Preventive medicine and dealing with medical problems by methods other than the use of drugs, e.g. walking and diet for Type II diabetes, could do with more promotion. While the price of pharmaceutical products is, of course, of great concern to consumers, doctors generally find the input of local pharmacists to be very useful and their concerns must be addressed. An article in the BMJ in December stressed the value of the input of pharmacists in reducing unnecessary G.P. visits and ensuring the compliance of patients in taking medication.

The value of competition has to be recognised and there have been amazing examples of decisions made regarding siting of pharmacies in too close proximity to another - Knock is the classic example. Refusal has been given to open a pharmacy for years because of the small population but no account taken of all the pilgrims that visit. Young pharmacists were at a great disadvantage, too, buying an existing pharmacy being the only way to enter the market. Let us hope the Review Committee works with speed. The attempt by Gehe, the German Pharmaceutical chain to back out of its deal with Unicare shows that this is a volatile area.

Senator Mary Henry, MD

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