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Poland: Abortion
1083
Spain: Drug regulations In its efforts to achieve European standards, the Health Ministry has prepared a list of drugs that will no longer be reimbursed by the Spanish National Health Service (SNHS). Spaniards (except pensioners) pay 40% of the price of the medicines. A Royal decree regulating the selection of drugs to be funded by SNHS was published in January. It is the first of a series of laws intended to improve drug availability as well as fmancing by public funds. The main points of the Royal decree are basically the withdrawal of eligibility for reimbursement of several groups of medicines; the review of the list of drugs eligible for reduced payment (ie, those for the treatment of chronic diseases); the separation of the process of drug licensing and that of its subsequent inclusion in SNHS; and the annual update of the list of drugs accepted for reimbursement. Meanwhile, a National Commission for Rational Drug Use was created to act as a government advisory board. This commission included representatives from Spanish Ministries, the pharmaceutical industry, physicians’ organisations, trade unions, and consumer’s organisations. The therapeutic groups excluded from reimbursement have been mainly those for the treatment of minor
dermatological conditions (such as warts or callouses), nutritional supplements (many vitamin-based medicines), and a long list of medicines used in the treatment of minor troubles such as flatulence, gastric discomfort, constipation, diarrhoea, and influenza. For the patient, the review of the drugs included in the list for reduced payment means that the maximum cost of medicines for the treatment of chronic diseases will be 10% of the total price, with a maximum of 400 pesetas. The cost will be updated annually according to the increase in the consumer price index. This measure brings up to date the cost of these drugs, which has remained at 50 pesetas since 1966. The review has also led to the exclusion of some groups of medicines-for example, calcitonin (except for the treatment of Paget’s disease), for which patients (except pensioners) will have to pay the usual 40% of the total price. The annual updating of the list of reimbursed drugs has been the issue most strongly opposed. So far the licensing of a new drug has been followed by a practically automatic inclusion in the list of medicines reimbursed by SNHS. It has meant that an accurate economic evaluation was required before final approval. With the separation of the processes of licensing and approval for reimbursement, registration will rely basically on scientific grounds and the inclusion in the SNHS list will be decided after evaluation of economic aspects and social needs. The point in the Royal decree objected to by Farmaindustria, the Spanish pharmaceutical manufacturers’ association is that a drug can be excluded from the reimbursement list after a year if a cheaper or better alternative becomes available. Farmaindustria argues that this measure could greatly discourage research effort and opposes the bill. Trade unions, consumers’ groups, pensioners, and chronic patients’ associations basically agree with the bill. By contrast, some political parties (ie, the conservative Popular Party and the leftist United Left) have reported their opposition. The General Council of Physicians and other medical organisations have opposed the bill on the grounds that it will limit their therapeutic freedom. Although it has been suggested that a "negative" list may reduce SNHS drug costs by 23 000 million pesetas, Farmaindustria contends that the actual reduction will be no
more than 2000 million to 3000 million because other medicines will be substituted. The drugs on the negative list tend to be cheap (mean price about 300 pesetas), so substitution could reasonably be expected to increase drug costs. However, the Ministry of Health has declared that the main objective is not so much reduction of drug costs but better use of existing resources. Thus, education rather than economy lay behind the decree, and in this sense, since many of the drugs removed from the reimbursable list were obsolete or were drug combinations of doubtful value, their exclusion is no scientific loss. However, what other longerterm consequences might arise from the annual update of reimbursable drugs is difficult to foresee. The bill following from the Royal decree was published earlier this month after its approval by the National Commission for Rational Drug Use, and will come into force on July 25.
Josep India:
E. Baños
Preparing for product patents
After extensive parliamentary debate, the Government have decided to adopt the system of product patents for pharmaceuticals but wants to buy time for the transition from the present system of process patents (see Lancet Jan 2, p 42 and Feb 20, p 485). In spelling out India’s stand on the Dunkel (GATT) draft text, the Vice-President Mr K. R. Narayanan said, "Basically, we go along with Dunkel because we want a world of free trade and we want global markets for our products". The fact that Narayanan made the statement while inaugurating the Sun Pharma Advanced Research Centre in Baroda, Gujarat, sends strong signals to the Indian pharmaceutical industry to modernise and increase spending on research and development, thereby helping the transition to a product patents system. With the process patents system pharmaceutical companies benefited from government laboratories without spending much on their own research. It was easy to buy processes from government laboratories. More than 80% of expenditure on R and D was by the Government. Now the share of private investment will have to increase. Sun Pharmaceuticals, a young and fully indigenous company, has taken the lead in committing substantial funds to R and D. According to Dilip Shanghvi, the company’s director, "We plan to spend 4% of our turnover on research as against the Indian pharmaceutical industry’s average of less than 1 %". The Government will be seeking modifications to the Dunkel draft text so that drugs manufactured abroad are not merely dumped in India, and so that the indigenous pharmaceutical industry is allowed to grow. Whether the changes that ensue will translate into better and cheaper drugs for the populace of 850 million remains to be seen. seems to
Bhupesh Mangla Poland: Abortion When Poland’s new anti-abortion law (see Lancet 1992; 339: 295 and 1992; 340: 963) came into force last month, Deputy Health Minister Marek Balicki predicted that the new ban on abortion for "social reasons" would lead to a flood of "abortion tourism" as well as back street abortions. He was right. Within a few days the first specialised travel agency had opened in Olsztyn in north-east Poland, offering "a full range of gynaecological services" across the border in
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the Russian province of Kaliningrad. US$200 buys a return coach trip from Olsztyn to Kaliningrad, a four-day stay in the Railway Workers’ Hospital (which has rented out three wards for the service), and the operation itself. The cost is roughly equivalent to the current average month’s salary but, as Moscow News commented, the current cost of an abortion in Poland is upwards of$800, depending on area, so a Kaliningrad abortion represents an economic option. The new law does not impose any penalty on the woman concerned, although the doctor doing an illegal abortion risks 2 years’ imprisonment (see Lancet 1991; 339: 1221). However, the charges cited by Moscow News indicate that there are doctors willing to take the risk. The welfare measures that were originally written into the bill were almost entirely voted out during the last phases of its passage through parliament. The decisons were a serious failing since the vast majority of abortions carried out in Poland over the past 45 years have been for social reasons-poor housing conditions, low wages (obliging a woman to return to work after childbirth), and no or inadequate facilities for infants and young children. The Minister of Labour and Social Welfare, Jacek Karon, has promised a special welfare programme for women in hardship, including support for lone mothers, better care for handicapped children, and psychological support for couples in the case of unwanted pregnancies, but none of these measures can be expected before the autumn.
Vera Rich
USA: Cryptosporidiosis outbreak Health officials estimate that as many as 200 000 residents the city of Milwaukee, Wisconsin, developed cryptosporidiosis in late March and early April from drinking contaminated water from the municipal water system. Milwaukee sits on the western shore of Lake Michigan, from which the city’s two water treatment plants draw water. Investigators suspect that the cryptosporidiosis came from the Milwaukee river, which passes through the city before it empties into the lake. The river may have been contaminated by water draining from cattle and dairy farms during mid-March. "There was a lot of rain and snow and the temperatures were right to bring on a spring thaw", said Dr.Thomas Schlenker, director of the Milwaukee Health Department. According to Schlenker evidence suggests that the protozoan entered the municipal water system through the city’s south water plant. "The river water when it hits the lake always turns south because of the prevailing wind and currents", he said. In addition, epidemiological mapping of cases had shown "a very dramatic increased risk for individuals who lived in the south side of town". Standard chlorination and filtration procedures used in the water plants would not have inhibited the protozoan’s oocysts, Schlenker added. Cryptosporidiosis can cause fever, abdominal pain, and cramps, and profuse diarrhoea, but the disease is virtually self-limited in healthy individuals, and since the city shut down the south plant, reports of new cases have been declining. But the outbreak has caused considerable concern in the city’s AIDS community. There is no known effective treatment for cryptosporidiosis, and infections in patients with low CD4 cell counts can become chronic, often debilitating, and sometimes fulminant and fatal. Doug Nelson, director of the Milwaukee AIDS coalition, said that 48% of 404 AIDS patients surveyed by his programme
of
reported experiencing symptoms suggestive of cryptosporidiosis in the past three weeks. In addition, 12 AID S patients had been admitted to hospital and 3 had died from dehydration due to diarrhoea, he said. His organisation will meet with city health officials to organise a study to assess the true impact of the outbreak on the AIDS population. Michael
McCarthy
Sweden: Abortions among teenagers halved The municipality of Gavie has halved the number of abortions among its teenagers by subsidising contraceptive pills for this age-group. The project started in 1989, when there were 75 abortions among girls aged between 15 and 19 years. In 1992, with annual costs of pills having been reduced from SKr 300 ([30) to SKr 90, there were 38 abortions in this age-group. The project, conducted by Vivi-Anne Rahm, head of FoU-Forum, the municipality’s research department, interrupted the trend of increasing number of registered abortions since 1985, the year when the current law on prescription was passed. According to this law, users are required to renew prescriptions every three months (instead of once a year). Their financial position often caused girls to postpone for a week or two the visit to the pharmacy. From 1987 to 1989,18% of abortions in Gavie were due to such lack of compliance. In 1992 the number was reduced to 2 % (representing three girls, two of whom had obtained their prescriptions before the project started). Besides reducing the number of abortions, the initiative stimulated the use of contraceptive pills, since 39% of adolescents now rely on them, compared with 32% in 1989 (the highest increase was among 19-year-old girls, from 42% to 60%). Already after its first year’s results the project had been considered successful and adopted by 70% of Swedish municipalities. Rahm now hopes that women between 20 and 24 years can be entitled to subsidised pills.
Cláudio Csillag
Germany: Prescription for the golden shot The Institute of Forensic Medicine, Munich University, has found that the percentage of deaths from narcotics overdose due to dihydrocodeine increased from 4% in 1986 to 17% in 1992 (Dt 4rM 1993; 90: 345-46C). In a further 20% of deaths dihydrocodeine was at least contributory. This rise was confined to two large Bavarian cities, Munich and Augsburg. The dihydrocodeine deaths in Munich and Augsburg were closely correlated temporally and geographically with prescriptions of up to two litres of 2 5% dihydrocodeine solution per week (mostly as aqueous solution and thus suitable for intravenous injection) and with the prescription, without close supervision, of other narcotic drugs. The large prescriptions of dihydrocodeine are the result of the understandable wish to help heroin-dependent patients and their families without infringing the narcotics law or the strict methadone-substitution rules. is Dihydrocodeine the active ingredient of several cough medicines not requiring special narcotics prescription. Whether addicts had found out its effect by trial and error, or whether a doctor knew that up to 10% of the compound is metabolised to morphine, is not known. In any case, news of
Spain: Drug regulations In its efforts to achieve European standards, the Health Ministry has prepared a list of drugs that will no longer be reimbursed by the Spanish National Health Service (SNHS). Spaniards (except pensioners) pay 40% of the price of the medicines. A Royal decree regulating the selection of drugs to be funded by SNHS was published in January. It is the first of a series of laws intended to improve drug availability as well as fmancing by public funds. The main points of the Royal decree are basically the withdrawal of eligibility for reimbursement of several groups of medicines; the review of the list of drugs eligible for reduced payment (ie, those for the treatment of chronic diseases); the separation of the process of drug licensing and that of its subsequent inclusion in SNHS; and the annual update of the list of drugs accepted for reimbursement. Meanwhile, a National Commission for Rational Drug Use was created to act as a government advisory board. This commission included representatives from Spanish Ministries, the pharmaceutical industry, physicians’ organisations, trade unions, and consumer’s organisations. The therapeutic groups excluded from reimbursement have been mainly those for the treatment of minor
dermatological conditions (such as warts or callouses), nutritional supplements (many vitamin-based medicines), and a long list of medicines used in the treatment of minor troubles such as flatulence, gastric discomfort, constipation, diarrhoea, and influenza. For the patient, the review of the drugs included in the list for reduced payment means that the maximum cost of medicines for the treatment of chronic diseases will be 10% of the total price, with a maximum of 400 pesetas. The cost will be updated annually according to the increase in the consumer price index. This measure brings up to date the cost of these drugs, which has remained at 50 pesetas since 1966. The review has also led to the exclusion of some groups of medicines-for example, calcitonin (except for the treatment of Paget’s disease), for which patients (except pensioners) will have to pay the usual 40% of the total price. The annual updating of the list of reimbursed drugs has been the issue most strongly opposed. So far the licensing of a new drug has been followed by a practically automatic inclusion in the list of medicines reimbursed by SNHS. It has meant that an accurate economic evaluation was required before final approval. With the separation of the processes of licensing and approval for reimbursement, registration will rely basically on scientific grounds and the inclusion in the SNHS list will be decided after evaluation of economic aspects and social needs. The point in the Royal decree objected to by Farmaindustria, the Spanish pharmaceutical manufacturers’ association is that a drug can be excluded from the reimbursement list after a year if a cheaper or better alternative becomes available. Farmaindustria argues that this measure could greatly discourage research effort and opposes the bill. Trade unions, consumers’ groups, pensioners, and chronic patients’ associations basically agree with the bill. By contrast, some political parties (ie, the conservative Popular Party and the leftist United Left) have reported their opposition. The General Council of Physicians and other medical organisations have opposed the bill on the grounds that it will limit their therapeutic freedom. Although it has been suggested that a "negative" list may reduce SNHS drug costs by 23 000 million pesetas, Farmaindustria contends that the actual reduction will be no
more than 2000 million to 3000 million because other medicines will be substituted. The drugs on the negative list tend to be cheap (mean price about 300 pesetas), so substitution could reasonably be expected to increase drug costs. However, the Ministry of Health has declared that the main objective is not so much reduction of drug costs but better use of existing resources. Thus, education rather than economy lay behind the decree, and in this sense, since many of the drugs removed from the reimbursable list were obsolete or were drug combinations of doubtful value, their exclusion is no scientific loss. However, what other longerterm consequences might arise from the annual update of reimbursable drugs is difficult to foresee. The bill following from the Royal decree was published earlier this month after its approval by the National Commission for Rational Drug Use, and will come into force on July 25.
Josep India:
E. Baños
Preparing for product patents
After extensive parliamentary debate, the Government have decided to adopt the system of product patents for pharmaceuticals but wants to buy time for the transition from the present system of process patents (see Lancet Jan 2, p 42 and Feb 20, p 485). In spelling out India’s stand on the Dunkel (GATT) draft text, the Vice-President Mr K. R. Narayanan said, "Basically, we go along with Dunkel because we want a world of free trade and we want global markets for our products". The fact that Narayanan made the statement while inaugurating the Sun Pharma Advanced Research Centre in Baroda, Gujarat, sends strong signals to the Indian pharmaceutical industry to modernise and increase spending on research and development, thereby helping the transition to a product patents system. With the process patents system pharmaceutical companies benefited from government laboratories without spending much on their own research. It was easy to buy processes from government laboratories. More than 80% of expenditure on R and D was by the Government. Now the share of private investment will have to increase. Sun Pharmaceuticals, a young and fully indigenous company, has taken the lead in committing substantial funds to R and D. According to Dilip Shanghvi, the company’s director, "We plan to spend 4% of our turnover on research as against the Indian pharmaceutical industry’s average of less than 1 %". The Government will be seeking modifications to the Dunkel draft text so that drugs manufactured abroad are not merely dumped in India, and so that the indigenous pharmaceutical industry is allowed to grow. Whether the changes that ensue will translate into better and cheaper drugs for the populace of 850 million remains to be seen. seems to
Bhupesh Mangla Poland: Abortion When Poland’s new anti-abortion law (see Lancet 1992; 339: 295 and 1992; 340: 963) came into force last month, Deputy Health Minister Marek Balicki predicted that the new ban on abortion for "social reasons" would lead to a flood of "abortion tourism" as well as back street abortions. He was right. Within a few days the first specialised travel agency had opened in Olsztyn in north-east Poland, offering "a full range of gynaecological services" across the border in
1084
the Russian province of Kaliningrad. US$200 buys a return coach trip from Olsztyn to Kaliningrad, a four-day stay in the Railway Workers’ Hospital (which has rented out three wards for the service), and the operation itself. The cost is roughly equivalent to the current average month’s salary but, as Moscow News commented, the current cost of an abortion in Poland is upwards of$800, depending on area, so a Kaliningrad abortion represents an economic option. The new law does not impose any penalty on the woman concerned, although the doctor doing an illegal abortion risks 2 years’ imprisonment (see Lancet 1991; 339: 1221). However, the charges cited by Moscow News indicate that there are doctors willing to take the risk. The welfare measures that were originally written into the bill were almost entirely voted out during the last phases of its passage through parliament. The decisons were a serious failing since the vast majority of abortions carried out in Poland over the past 45 years have been for social reasons-poor housing conditions, low wages (obliging a woman to return to work after childbirth), and no or inadequate facilities for infants and young children. The Minister of Labour and Social Welfare, Jacek Karon, has promised a special welfare programme for women in hardship, including support for lone mothers, better care for handicapped children, and psychological support for couples in the case of unwanted pregnancies, but none of these measures can be expected before the autumn.
Vera Rich
USA: Cryptosporidiosis outbreak Health officials estimate that as many as 200 000 residents the city of Milwaukee, Wisconsin, developed cryptosporidiosis in late March and early April from drinking contaminated water from the municipal water system. Milwaukee sits on the western shore of Lake Michigan, from which the city’s two water treatment plants draw water. Investigators suspect that the cryptosporidiosis came from the Milwaukee river, which passes through the city before it empties into the lake. The river may have been contaminated by water draining from cattle and dairy farms during mid-March. "There was a lot of rain and snow and the temperatures were right to bring on a spring thaw", said Dr.Thomas Schlenker, director of the Milwaukee Health Department. According to Schlenker evidence suggests that the protozoan entered the municipal water system through the city’s south water plant. "The river water when it hits the lake always turns south because of the prevailing wind and currents", he said. In addition, epidemiological mapping of cases had shown "a very dramatic increased risk for individuals who lived in the south side of town". Standard chlorination and filtration procedures used in the water plants would not have inhibited the protozoan’s oocysts, Schlenker added. Cryptosporidiosis can cause fever, abdominal pain, and cramps, and profuse diarrhoea, but the disease is virtually self-limited in healthy individuals, and since the city shut down the south plant, reports of new cases have been declining. But the outbreak has caused considerable concern in the city’s AIDS community. There is no known effective treatment for cryptosporidiosis, and infections in patients with low CD4 cell counts can become chronic, often debilitating, and sometimes fulminant and fatal. Doug Nelson, director of the Milwaukee AIDS coalition, said that 48% of 404 AIDS patients surveyed by his programme
of
reported experiencing symptoms suggestive of cryptosporidiosis in the past three weeks. In addition, 12 AID S patients had been admitted to hospital and 3 had died from dehydration due to diarrhoea, he said. His organisation will meet with city health officials to organise a study to assess the true impact of the outbreak on the AIDS population. Michael
McCarthy
Sweden: Abortions among teenagers halved The municipality of Gavie has halved the number of abortions among its teenagers by subsidising contraceptive pills for this age-group. The project started in 1989, when there were 75 abortions among girls aged between 15 and 19 years. In 1992, with annual costs of pills having been reduced from SKr 300 ([30) to SKr 90, there were 38 abortions in this age-group. The project, conducted by Vivi-Anne Rahm, head of FoU-Forum, the municipality’s research department, interrupted the trend of increasing number of registered abortions since 1985, the year when the current law on prescription was passed. According to this law, users are required to renew prescriptions every three months (instead of once a year). Their financial position often caused girls to postpone for a week or two the visit to the pharmacy. From 1987 to 1989,18% of abortions in Gavie were due to such lack of compliance. In 1992 the number was reduced to 2 % (representing three girls, two of whom had obtained their prescriptions before the project started). Besides reducing the number of abortions, the initiative stimulated the use of contraceptive pills, since 39% of adolescents now rely on them, compared with 32% in 1989 (the highest increase was among 19-year-old girls, from 42% to 60%). Already after its first year’s results the project had been considered successful and adopted by 70% of Swedish municipalities. Rahm now hopes that women between 20 and 24 years can be entitled to subsidised pills.
Cláudio Csillag
Germany: Prescription for the golden shot The Institute of Forensic Medicine, Munich University, has found that the percentage of deaths from narcotics overdose due to dihydrocodeine increased from 4% in 1986 to 17% in 1992 (Dt 4rM 1993; 90: 345-46C). In a further 20% of deaths dihydrocodeine was at least contributory. This rise was confined to two large Bavarian cities, Munich and Augsburg. The dihydrocodeine deaths in Munich and Augsburg were closely correlated temporally and geographically with prescriptions of up to two litres of 2 5% dihydrocodeine solution per week (mostly as aqueous solution and thus suitable for intravenous injection) and with the prescription, without close supervision, of other narcotic drugs. The large prescriptions of dihydrocodeine are the result of the understandable wish to help heroin-dependent patients and their families without infringing the narcotics law or the strict methadone-substitution rules. is Dihydrocodeine the active ingredient of several cough medicines not requiring special narcotics prescription. Whether addicts had found out its effect by trial and error, or whether a doctor knew that up to 10% of the compound is metabolised to morphine, is not known. In any case, news of