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EC drugs wrangle
News Proposed changes abortion training
the rules has been changed. The only clarification now is that it would not prevent women from other countries coming here for treatment. Women will be required to A fresh interpretation of what is meant by be resident in the country for 10-14 days, "resident in England and Wales" has which includes a compulsory follow-up 7 paved the way for foreign women to come days after treatment. In France and Sweto this country for termination of pregden the two other countries where with Since the end mifepristone. of nancy mifepristone is approved and available for 1991, when mifepristone was approved use as an abortifacient, treatment is still for this use in non-NHS clinics, there limited to nationals. A spokeswoman for have been strict guidelines governing its Marie Stopes International London office administration. Although one of these said that they had had numerous telerequirements is that the woman should be phone calls in the past few days from resident in England and Wales, private women wanting medical terminationsclinics have sought permission to treat most were US nationals. The organisation women not normally resident in the counhas been urging women to check that their try. The health department has turned pregnancy is suitable for termination by down such requests in the past but last mifepristone before "jumping on Conweek relented on a case brought to them corde". by Marie Stopes International. The department has emphasised that none of Sarah Ramsay
for non-residents
in US
The executive board of the American College of Obstetricians and Gynecologists (ACOG) now recommends that nonphysicians be trained to do abortions "in collaborative settings" alongside physicians. In a related move, the obstetricians and gynaecology residency review commitee of the Accreditation Council for Graduate Medical Education (ACGME) has proposed formally to allow abortion instruction "off campus". The two decisions come as access to abortion-both patient services and resident trainingdecline in the US while demand does not (see Lancet, Oct 16, 1993, p 939). The ACGME proposal is partly the result of a 1990 court decision affirming its right to withdraw accreditation from a Baltimore programme that, for religious reasons, limited abortion training in hospital and prohibited residents from outside instruction. The proposal is also a matter of educational practicalities. According to the Alan Guttmacher Institute, a New York research group, 90% of American abortions are done in doctors’ offices or clinics, beyond the walls of traditional hospital-based residences, and some trainees graduate with little experience. Thorny issues are raised by the ACOG proposal. Nearly all states have "physician only" laws prohibiting non-doctors from doing abortions. These were passed originally to protect women from unqualified providers, and many physicians (and midlevel providers alike) are reluctant to liberalise them. But those supporting change often cite the Vermont Women’s Center (VWHC), where physician assistants have been legally doing supervised firsttrimester abortions since 1973. An outcomes study of VWHC by the Vermont Department of Health in 1986 found "no differences between procedures performed by physicians and those performed by physician assistants with respect to overall, immediate or delayed complication rates" (Am J Publ Health 1986; 76: 55054), and the clinic has gained academic recognition and acceptance. Medical students and residents from the University of Vermont have rotated through VWHC for
Mifepristone
EC
price controls pose problems for industry. Flynn argued that free pricing direct
drugs wrangle
would be out of step with current trends towards tight controls on government health spending and that it did not fit with Maastricht treaty obligations to keep spending and budget deficits down. The row was by no means settled as The the pharmaceuticals sector, has been Lancet went to press, so another rewrite rewritten from the original draft that could well be in the offing. However, the Industry Commissioner Martin Bangefinal text will still call on governprobably mann first in the autumn.
Next week should see the release of a controversial European Commission communication on the pharmaceutical industry after months of internal wrangling. The communication, on industrial policy for
presented
:
Other commissioners, notably Social Affairs Commissioner Padraig Flynn, had objected to the emphasis on industry. : They wanted a greater stress on public : health protection instead. One of the main sticking points was pricing. The original draft had called for an end to direct government price controls, which Bangemann contends does not reduce national health expenditure. If the revised communication is adopted at the Commission’s weekly meeting next Wednesday, it is likely to say only that
encourage generic prescribing, to competition between drug firms. Flynn is also known to favour greater self-medication as a way of keeping health spending down, yet it is unlikely that he has backed the original draft’s calls to stop patient reimbursement for over-thecounter (OTC) products or having OTC drugs on prescription. He believes that reimbursement policy is none of the Comments to
boost
mission’s business. Sara Lewis All five drafts stress the importance of reporting by health professionals. Drug
Pharmacovigilance guidelines
firms are told to report adverse events to national authorities within 15 days of The European Union Committee for Prohearing about them even if they do not prietary Medicinal Products (CPMP) has agree with the reporting doctor’s assessreleased five draft guidelines on pharmament of a possible causal association. that highlights the doctor’s key When covigilance reports originate from pharmacists ten years. role in monitoring drug safety. Governthe authorities and industry and nurses To lower costs and increase access, the ments and industry have until April 15 to should be able to gain more information Clinton Administration supports expandcomment on the drafts. They cover from the doctor. patient’s ed duties for non-physician providers in adverse-reaction reporting by The guideline for competent authorities many areas of clinical medicine. But authorisation holders, periodic drug safety also stresses that identifiable personal such to serapplying philosophy abortion update reports, post-marketing surveildetails of reporting health professionals vices my be more complicated. "If we had lance, company-sponsored post-marketing must always be kept in confidence. In looked at abortion medically, and not safety studies, and the undertaking of post-marketing safety studies patient conpolitically", says Rachel Atkins, executive procedures for compepharmacovigilance fidentiality must be respected and respondirector and physician assistant at ’, tent authorities. Other guidelines will folsibility for retrieving information from VWHC, "from the point of view of risks ’, low on such as validation and personal medical records lies with the subjects and complications, mid-level providers evaluation of case-reports, patients’ expodoctor. would have been doing abortions a long sure to medicinal products, and arrange: time ago". ments for reporting adverse reactions not classified as serious.: Sara Lewis David H Frankel
marketing
535
the rules has been changed. The only clarification now is that it would not prevent women from other countries coming here for treatment. Women will be required to A fresh interpretation of what is meant by be resident in the country for 10-14 days, "resident in England and Wales" has which includes a compulsory follow-up 7 paved the way for foreign women to come days after treatment. In France and Sweto this country for termination of pregden the two other countries where with Since the end mifepristone. of nancy mifepristone is approved and available for 1991, when mifepristone was approved use as an abortifacient, treatment is still for this use in non-NHS clinics, there limited to nationals. A spokeswoman for have been strict guidelines governing its Marie Stopes International London office administration. Although one of these said that they had had numerous telerequirements is that the woman should be phone calls in the past few days from resident in England and Wales, private women wanting medical terminationsclinics have sought permission to treat most were US nationals. The organisation women not normally resident in the counhas been urging women to check that their try. The health department has turned pregnancy is suitable for termination by down such requests in the past but last mifepristone before "jumping on Conweek relented on a case brought to them corde". by Marie Stopes International. The department has emphasised that none of Sarah Ramsay
for non-residents
in US
The executive board of the American College of Obstetricians and Gynecologists (ACOG) now recommends that nonphysicians be trained to do abortions "in collaborative settings" alongside physicians. In a related move, the obstetricians and gynaecology residency review commitee of the Accreditation Council for Graduate Medical Education (ACGME) has proposed formally to allow abortion instruction "off campus". The two decisions come as access to abortion-both patient services and resident trainingdecline in the US while demand does not (see Lancet, Oct 16, 1993, p 939). The ACGME proposal is partly the result of a 1990 court decision affirming its right to withdraw accreditation from a Baltimore programme that, for religious reasons, limited abortion training in hospital and prohibited residents from outside instruction. The proposal is also a matter of educational practicalities. According to the Alan Guttmacher Institute, a New York research group, 90% of American abortions are done in doctors’ offices or clinics, beyond the walls of traditional hospital-based residences, and some trainees graduate with little experience. Thorny issues are raised by the ACOG proposal. Nearly all states have "physician only" laws prohibiting non-doctors from doing abortions. These were passed originally to protect women from unqualified providers, and many physicians (and midlevel providers alike) are reluctant to liberalise them. But those supporting change often cite the Vermont Women’s Center (VWHC), where physician assistants have been legally doing supervised firsttrimester abortions since 1973. An outcomes study of VWHC by the Vermont Department of Health in 1986 found "no differences between procedures performed by physicians and those performed by physician assistants with respect to overall, immediate or delayed complication rates" (Am J Publ Health 1986; 76: 55054), and the clinic has gained academic recognition and acceptance. Medical students and residents from the University of Vermont have rotated through VWHC for
Mifepristone
EC
price controls pose problems for industry. Flynn argued that free pricing direct
drugs wrangle
would be out of step with current trends towards tight controls on government health spending and that it did not fit with Maastricht treaty obligations to keep spending and budget deficits down. The row was by no means settled as The the pharmaceuticals sector, has been Lancet went to press, so another rewrite rewritten from the original draft that could well be in the offing. However, the Industry Commissioner Martin Bangefinal text will still call on governprobably mann first in the autumn.
Next week should see the release of a controversial European Commission communication on the pharmaceutical industry after months of internal wrangling. The communication, on industrial policy for
presented
:
Other commissioners, notably Social Affairs Commissioner Padraig Flynn, had objected to the emphasis on industry. : They wanted a greater stress on public : health protection instead. One of the main sticking points was pricing. The original draft had called for an end to direct government price controls, which Bangemann contends does not reduce national health expenditure. If the revised communication is adopted at the Commission’s weekly meeting next Wednesday, it is likely to say only that
encourage generic prescribing, to competition between drug firms. Flynn is also known to favour greater self-medication as a way of keeping health spending down, yet it is unlikely that he has backed the original draft’s calls to stop patient reimbursement for over-thecounter (OTC) products or having OTC drugs on prescription. He believes that reimbursement policy is none of the Comments to
boost
mission’s business. Sara Lewis All five drafts stress the importance of reporting by health professionals. Drug
Pharmacovigilance guidelines
firms are told to report adverse events to national authorities within 15 days of The European Union Committee for Prohearing about them even if they do not prietary Medicinal Products (CPMP) has agree with the reporting doctor’s assessreleased five draft guidelines on pharmament of a possible causal association. that highlights the doctor’s key When covigilance reports originate from pharmacists ten years. role in monitoring drug safety. Governthe authorities and industry and nurses To lower costs and increase access, the ments and industry have until April 15 to should be able to gain more information Clinton Administration supports expandcomment on the drafts. They cover from the doctor. patient’s ed duties for non-physician providers in adverse-reaction reporting by The guideline for competent authorities many areas of clinical medicine. But authorisation holders, periodic drug safety also stresses that identifiable personal such to serapplying philosophy abortion update reports, post-marketing surveildetails of reporting health professionals vices my be more complicated. "If we had lance, company-sponsored post-marketing must always be kept in confidence. In looked at abortion medically, and not safety studies, and the undertaking of post-marketing safety studies patient conpolitically", says Rachel Atkins, executive procedures for compepharmacovigilance fidentiality must be respected and respondirector and physician assistant at ’, tent authorities. Other guidelines will folsibility for retrieving information from VWHC, "from the point of view of risks ’, low on such as validation and personal medical records lies with the subjects and complications, mid-level providers evaluation of case-reports, patients’ expodoctor. would have been doing abortions a long sure to medicinal products, and arrange: time ago". ments for reporting adverse reactions not classified as serious.: Sara Lewis David H Frankel
marketing
535