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DRUGS AND THE COMMON MARKET
1115
proposal).
DRUGS AND THE COMMON MARKET
Sm,—We are surprised that the pharmaceutical problems arising from Great Britain joining the Common Market have not been more eagerly discussed in British medical journals. As we have similar problems here in Denmark,
colleagues on this development. Denmark has had a relatively restrictive policy leading to only some 2000 pharmaceutical products on the Danish market. One of the restrictive measures permits no more than three different names for the same drug: (1) the first proprietary name by the foreign company introducing the drug; (2) the first proprietary name by a Danish drug house bringing the same drug on the market; and (3) all following foreign or Danish companies have had to use the generic name (if the new drug was a Danish innovation this meant a maximum of two names). Another important part of the Danish system was to ban the importation of all foreign drug combinations and we
want to
inform British
the same time to have a very restrictive attitude introduction of national drug combinations. at
to
the
ments were
From the psychiatric point of view, we feel very emphatically that it should be a sovereign right for any country to stop the flood of psychoactive drugs, especially anxiolytics, and any combination of psychopharmacological drugs. But we do not think that this is a special problem for psychiatry. We are not against the pharmaceutical industry; we are not advocating its nationalisation or socialisation, but we feel that doctors should be very active in hammering out these important rules for the E.E.C. (and as a matter of fact for any country in the world). The E.E.C. was primarily an economic liaison, which now at a later stage is looking for its ethics.
We think that health is an area where ethics should go before economy, but where common laws accepting this for the E.E.C. will benefit us all-and in the end also the economy of the health services in the member countries. 0 Albion, let thine voice be heard! Psychochemistry Institute, Rigshospitalet, 9 Blegdamsvej, DK-2100 Copenhagen,
In contrast to this, most of the old E.E.C. countries have had many more drugs (and combined drugs) on the market. Estimates for the German Federal Republic run from 30,000 to 70,000 pharmaceutical products. In 1965 the E.E.C. passed the First Directive (65/65) on of Provisions laid down by Law, Regulation or Administrative Action relating to Proprietary Medical Products. But this directive was never enforced by the member countries. As part of a new economic strategy, it has been proposed that all the nine member countries should ensure the functioning of this directive, and the new member countries have been asked their
Approximation
opinion. In our view this First Directive is unacceptable for Denmark, since it clearly defines the four sole causes for
rejection of a new pharmaceutical product: (1) that it is harmful; (2) that it lacks therapeutic effect or that the therapeutic effect is not sufficiently documented; (3) that it has not the stated qualitative or quantitative composition; or (4) that the application does not comply with the rules. It is clearly stated that marketing can be barred only according to these four clauses. On the contrary, it will not, in our opinion, be possible to stop products (e.g., combinations) according to other principles. We think it is better to have 2000 (or 1000) rather than 5000 or 10,000 products on the market, because it becomes even more difficult for the medical world to adjust to the increasing numbers of drugs and rapidly to register dangerous sideeffects. At the same time increasing numbers of drugs will enhance fashion swings induced by market distortion due to advertising campaigns, and such fashions are costly for the patients or the national agencies responsible for footing drug bills. This is the short E.E.C. perspective, but the long view is more promising. The E.E.C. has a series of directives in preparation, and when we come to the Proposal of Directive KOM (70) 99 the outlook is much brighter. This Proposal of Directive has such a high standard for the obligatory analytical, pharmacotoxicological, and clinical testing and trials for any new drug application that
none
of the nine countries rules and
appropriate and strict as yet a proposal.
at
present have similar But this is
regulations.
The Danish Government has made reservations concerning the First Directive (and the proposed Second Directive, which is not much better). We have suggested that the Danish Government should demand the simultaneous acceptance by all nine countries of the whole series of directives in this field (including the high-standard
It would be even more advantageous if amendmade to the clauses in the First Directive.
OLE J. RAFAELSEN LARS F. GRAM.
SALMONELLOSIS IN ANIMALS AND MAN SIR,-In common with Dr Gangarosa and his colleagues,l " we have followed with interest the correspondence sparked off " by the 1972 editorial.2 While in general I agree with most of what has been said, I cannot avoid the feeling that, like the prelates of old, we argue over fine doctrinal points while the heathen remain unconverted. The most salient statistic in my view is that only an estimated 1% of human cases are reported in the U.S.A. Another disquieting statistic is that of this 1% actual In the U.S.A. cases reported, only 5% are investigated. a have well-structured Centre for Disease Control they with medical and veterinary components; in the U.K. the percentage figures are probably even lower. In the veterinary field there are many who are more than a little concerned that there appears to be a general spread north in the U.K. of salmonella, and in particular Salmonella typhimurium in the bovine. In England and Wales and in Scotland there has been a considerable increase in cases of the latter recorded by veterinary investigation centres. If this is taken to represent only around 1% of actual cases, and it is likely that the figure is of this orderveterinary practitioners being no more assiduous in having laboratory checks done than are medical practitioners-the trends are alarming to say the least. And yet what is being done, other than recording data reported by laboratories ? Some 2 years ago, on a fine day in November, when my in-tray " was low, I went forth to investigate what was eventually confirmed as a case of S. typhimurium, phage 32, in a baby calf. That sunny afternoon I picked up a further 7 cases on 7 individual farms, simply by "
following the route taken by a calf dealer’s lorry, some 10 days earlier, when the latter had gone round the countryside shedding his load of calves (and salmonella) to the unsuspecting buyers. At the same time I noted that 2 of the farmers were obviously ill, and these were later confirmed as cases of salmonellosis. In one case other members of the family were also affected-possibly person-to-person infection. So, during the afternoon I " netted " 7 veterinary cases and at least 2 medical cases of S. typhimurium. Gangarosa, E. J., Barker, W. H., Baine, W. B., Morris, G. K., Rice, P. A. Lancet, April 21, 1973, p. 878. 2. ibid. 1972, i, 830. 1.
proposal).
DRUGS AND THE COMMON MARKET
Sm,—We are surprised that the pharmaceutical problems arising from Great Britain joining the Common Market have not been more eagerly discussed in British medical journals. As we have similar problems here in Denmark,
colleagues on this development. Denmark has had a relatively restrictive policy leading to only some 2000 pharmaceutical products on the Danish market. One of the restrictive measures permits no more than three different names for the same drug: (1) the first proprietary name by the foreign company introducing the drug; (2) the first proprietary name by a Danish drug house bringing the same drug on the market; and (3) all following foreign or Danish companies have had to use the generic name (if the new drug was a Danish innovation this meant a maximum of two names). Another important part of the Danish system was to ban the importation of all foreign drug combinations and we
want to
inform British
the same time to have a very restrictive attitude introduction of national drug combinations. at
to
the
ments were
From the psychiatric point of view, we feel very emphatically that it should be a sovereign right for any country to stop the flood of psychoactive drugs, especially anxiolytics, and any combination of psychopharmacological drugs. But we do not think that this is a special problem for psychiatry. We are not against the pharmaceutical industry; we are not advocating its nationalisation or socialisation, but we feel that doctors should be very active in hammering out these important rules for the E.E.C. (and as a matter of fact for any country in the world). The E.E.C. was primarily an economic liaison, which now at a later stage is looking for its ethics.
We think that health is an area where ethics should go before economy, but where common laws accepting this for the E.E.C. will benefit us all-and in the end also the economy of the health services in the member countries. 0 Albion, let thine voice be heard! Psychochemistry Institute, Rigshospitalet, 9 Blegdamsvej, DK-2100 Copenhagen,
In contrast to this, most of the old E.E.C. countries have had many more drugs (and combined drugs) on the market. Estimates for the German Federal Republic run from 30,000 to 70,000 pharmaceutical products. In 1965 the E.E.C. passed the First Directive (65/65) on of Provisions laid down by Law, Regulation or Administrative Action relating to Proprietary Medical Products. But this directive was never enforced by the member countries. As part of a new economic strategy, it has been proposed that all the nine member countries should ensure the functioning of this directive, and the new member countries have been asked their
Approximation
opinion. In our view this First Directive is unacceptable for Denmark, since it clearly defines the four sole causes for
rejection of a new pharmaceutical product: (1) that it is harmful; (2) that it lacks therapeutic effect or that the therapeutic effect is not sufficiently documented; (3) that it has not the stated qualitative or quantitative composition; or (4) that the application does not comply with the rules. It is clearly stated that marketing can be barred only according to these four clauses. On the contrary, it will not, in our opinion, be possible to stop products (e.g., combinations) according to other principles. We think it is better to have 2000 (or 1000) rather than 5000 or 10,000 products on the market, because it becomes even more difficult for the medical world to adjust to the increasing numbers of drugs and rapidly to register dangerous sideeffects. At the same time increasing numbers of drugs will enhance fashion swings induced by market distortion due to advertising campaigns, and such fashions are costly for the patients or the national agencies responsible for footing drug bills. This is the short E.E.C. perspective, but the long view is more promising. The E.E.C. has a series of directives in preparation, and when we come to the Proposal of Directive KOM (70) 99 the outlook is much brighter. This Proposal of Directive has such a high standard for the obligatory analytical, pharmacotoxicological, and clinical testing and trials for any new drug application that
none
of the nine countries rules and
appropriate and strict as yet a proposal.
at
present have similar But this is
regulations.
The Danish Government has made reservations concerning the First Directive (and the proposed Second Directive, which is not much better). We have suggested that the Danish Government should demand the simultaneous acceptance by all nine countries of the whole series of directives in this field (including the high-standard
It would be even more advantageous if amendmade to the clauses in the First Directive.
OLE J. RAFAELSEN LARS F. GRAM.
SALMONELLOSIS IN ANIMALS AND MAN SIR,-In common with Dr Gangarosa and his colleagues,l " we have followed with interest the correspondence sparked off " by the 1972 editorial.2 While in general I agree with most of what has been said, I cannot avoid the feeling that, like the prelates of old, we argue over fine doctrinal points while the heathen remain unconverted. The most salient statistic in my view is that only an estimated 1% of human cases are reported in the U.S.A. Another disquieting statistic is that of this 1% actual In the U.S.A. cases reported, only 5% are investigated. a have well-structured Centre for Disease Control they with medical and veterinary components; in the U.K. the percentage figures are probably even lower. In the veterinary field there are many who are more than a little concerned that there appears to be a general spread north in the U.K. of salmonella, and in particular Salmonella typhimurium in the bovine. In England and Wales and in Scotland there has been a considerable increase in cases of the latter recorded by veterinary investigation centres. If this is taken to represent only around 1% of actual cases, and it is likely that the figure is of this orderveterinary practitioners being no more assiduous in having laboratory checks done than are medical practitioners-the trends are alarming to say the least. And yet what is being done, other than recording data reported by laboratories ? Some 2 years ago, on a fine day in November, when my in-tray " was low, I went forth to investigate what was eventually confirmed as a case of S. typhimurium, phage 32, in a baby calf. That sunny afternoon I picked up a further 7 cases on 7 individual farms, simply by "
following the route taken by a calf dealer’s lorry, some 10 days earlier, when the latter had gone round the countryside shedding his load of calves (and salmonella) to the unsuspecting buyers. At the same time I noted that 2 of the farmers were obviously ill, and these were later confirmed as cases of salmonellosis. In one case other members of the family were also affected-possibly person-to-person infection. So, during the afternoon I " netted " 7 veterinary cases and at least 2 medical cases of S. typhimurium. Gangarosa, E. J., Barker, W. H., Baine, W. B., Morris, G. K., Rice, P. A. Lancet, April 21, 1973, p. 878. 2. ibid. 1972, i, 830. 1.