Public Health and the Law
The European Scene BY
WILLIAM J. CURRAN, JD, SMHYG
As indicated in my previous column beginning this new series, I am on sabbatical leave this year, based in Geneva, semi-attached to the World Health Association headquarters. It is pleasant to be more of an observer than a participant for a change, although there are many restless moments. On the day of my arrival in Geneva, WHO announced "India had accomplished the impossible-broken the back of smallpox. . . " and was smallpox free.' It was most gratifying, although I had nothing to do with the achievement, of course. I was not pleased with the metaphoric reference to the vertebra of the virus, but I didn't have anything to do with the press release either. At WHO, I found that the Health Legislation Section was continuing to function under the experienced guidance of Dr. Jean DeMoerloose. The Section publishes the International Digest of Health Legislation, a unique publication in the field of international law, and acts in an advisory capacity concerning health legislation for member nations and for internal groups and expert committees at WHO. In recent years the most significant new areas of interest for the Section are human rights in health and medical ethical questions. Both the industrialized countries and the developing nations of the world have serious concerns in these fields. It is noteworthy that in this same vein the Twenty-Ninth World Medical Assembly of the World Medical Association, meeting in Tokyo in October last year, adopted three statements in the area of human rights and ethics. The first was a declaration admonishing physicians from taking part in any form of torture, or other cruel or inhuman or degrading treatment or punishment of prisoners. The document was provoked, apparently, not only by allegations of involvement in certain states in South America and Eastern Europe, but also in Northern Ireland. The second statement came in the form of extensive amendments to the so-called Declaration of Helsinki concerning the responsibilities of physicians in clinical investigation. The Declaration was first adopted in 1964. All of the amendments add considerable sophistication to the document and provide greater protection for research subjects. Of particular importance is a new provision which requires that all research protocols "be transmitted to a specially appointed independent committee for consideration, comment 178
and guidance."2 Although it is rather vaguely worded, the provision seems to impose the practice begun in the United States some years ago of requiring all research projects supported by the Federal Government to be reviewed and approved by an ethics committee charged with protecting the welfare of research subjects. Here in Europe I have as yet found this system is used only in Great Britain and Ireland. The third statement was more of a surprise than the other two since copies of the draft resolution were not circulated in Europe before the meeting. This was a statement cautioning all physicians to use psychotropic drugs only with "the greatest restraint," being mindful of the dangers of misuse and abuse. Physicians were also encouraged to accept responsibility for providing information regarding the health hazards of all psychotropic substances, including alcohol. For public health, the last of the three statements may be of the greatest significance. There has been very little background information about this statement from the WMA offices which are now located in a French suburb of Geneva. On a broad scale, the most far-reaching recent development in health law in Europe has been the action of the European Economic Community, (EEC), composed of nine of the nations in Western Europe, in removing the legal barriers to free movement and practice of medicine by physicians within the Common Market. The document is officially known as the "Council Directive Concerning the Mutual Recognition of Diplomas, Certifications and Other Evidence of Formal Qualification in Medicine, Including Measures to Facilitate the Effective Exercise of the Right of Establishment and Freedom to Provide Services."3 As in every legal document, one should be careful to read and give significance to every word. One of the cardinal rules of legal interpretation is that there are no superfluous words in a statute. This is true of titles as well as of text. The above title says mutual recognition, not merely reciprocity. We have had reciprocity between American states for years, but not mutual recognition. Under reciprocity, one jurisdiction can retaliate against the other for real or imagined discrimination and the battles of cooperation and competition can go on endlessly. This European document requires mutual recognition. No special provisions can be adopted to apply to one other country in the Nine; recognition of the qualifications must be extended uniformly to all. It should be noted also that the title AJPH February, 1976, Vol. 66, No. 2
PUBLIC HEALTH & THE LAW
bases this recognition on a "right" to establishment and a "freedom" to practice one's profession. These are strong operative words in law. The Common Market Treaty of Rome is based on a philosophy of free movement and free commerce. The individual is given a right under this Directive, not a mere privilege which may be recognized or not by member states. Within the document the basic requirement for recognition of qualification is a total of 5,500 hours of attendance at medical school. No nation in the EEC has less than these hours for graduation from medical school. The member nations are not allowed to impose any quality test on these hours; it is solely a quantitative requirement. Currently the Directive is being reviewed in the member states where the national parliaments are expected to pass the necessary enabling legislation this year. This Directive is the first major piece of health-care-related law-making ever to be adopted by the European Economic Community.
Other cooperative efforts in health law are being discussed in the EEC as well as in the European Free Trade Association and the Council of Europe. These concern such matters as water and stream pollution, patent and copyright laws, pharmaceutical industry matters, and the imposition of strict manufacturers' liability for personal injuries received by users and consumers of products. There is no doubt but that progress is being made in Europe in the movement toward international health law, although there is a great deal yet to be done to achieve uniformity in this field in all areas of concem to the public's health.
REFERENCES 1. WHO Press Release No. 27, 15 August 1975. 2. WMA Declaration of Helsinki, Amendments, October, 1975, Section I, Basic Principles, Section 2. 3. EEC Council Directive, Number 2121 (E.S. 195).
LEGAL TRAINING PROGRAM ON MINOR'S HEALTH RIGHTS ESTABLISHED A Children's Legal Rights Information and Training Program has recently been created at Catholic University in Washington, D.C. In conjunction with this program, faculty will be sent to a variety of locations around the nation to offer custom-made workshops to medical personnel on the legal issues arising in the treatment of minors. These workshops will be given for academic credit and will be individually designed to provide an in-depth study of the laws and cases of each jurisdiction as well as a picture of the legal trends which are developing in the United States. The program will offer training in the areas of: * Child abuse and neglect * Medical care for minors without parental consent * Informed parental consent and privileged communication * Confidentiality between doctor and minor patient * Emancipated minor and health services * Common law and the treatment of minors * Statutes offering minors treatment for VD, drug abuse, abortion, contraceptive care * Mental health and the child * Courtroom practice and procedure for the expert witness. Any agency, institution, or organization interested in finding out more about the program should contact Dr. Roberta Gottesmann, Director, Children's Legal Rights Information and Program Training, National Catholic School of Social Services, Catholic University of America, Washington, D.C. 20017.
AJPH February, 1976, Vol. 66, No. 2
179
The European Scene BY
WILLIAM J. CURRAN, JD, SMHYG
As indicated in my previous column beginning this new series, I am on sabbatical leave this year, based in Geneva, semi-attached to the World Health Association headquarters. It is pleasant to be more of an observer than a participant for a change, although there are many restless moments. On the day of my arrival in Geneva, WHO announced "India had accomplished the impossible-broken the back of smallpox. . . " and was smallpox free.' It was most gratifying, although I had nothing to do with the achievement, of course. I was not pleased with the metaphoric reference to the vertebra of the virus, but I didn't have anything to do with the press release either. At WHO, I found that the Health Legislation Section was continuing to function under the experienced guidance of Dr. Jean DeMoerloose. The Section publishes the International Digest of Health Legislation, a unique publication in the field of international law, and acts in an advisory capacity concerning health legislation for member nations and for internal groups and expert committees at WHO. In recent years the most significant new areas of interest for the Section are human rights in health and medical ethical questions. Both the industrialized countries and the developing nations of the world have serious concerns in these fields. It is noteworthy that in this same vein the Twenty-Ninth World Medical Assembly of the World Medical Association, meeting in Tokyo in October last year, adopted three statements in the area of human rights and ethics. The first was a declaration admonishing physicians from taking part in any form of torture, or other cruel or inhuman or degrading treatment or punishment of prisoners. The document was provoked, apparently, not only by allegations of involvement in certain states in South America and Eastern Europe, but also in Northern Ireland. The second statement came in the form of extensive amendments to the so-called Declaration of Helsinki concerning the responsibilities of physicians in clinical investigation. The Declaration was first adopted in 1964. All of the amendments add considerable sophistication to the document and provide greater protection for research subjects. Of particular importance is a new provision which requires that all research protocols "be transmitted to a specially appointed independent committee for consideration, comment 178
and guidance."2 Although it is rather vaguely worded, the provision seems to impose the practice begun in the United States some years ago of requiring all research projects supported by the Federal Government to be reviewed and approved by an ethics committee charged with protecting the welfare of research subjects. Here in Europe I have as yet found this system is used only in Great Britain and Ireland. The third statement was more of a surprise than the other two since copies of the draft resolution were not circulated in Europe before the meeting. This was a statement cautioning all physicians to use psychotropic drugs only with "the greatest restraint," being mindful of the dangers of misuse and abuse. Physicians were also encouraged to accept responsibility for providing information regarding the health hazards of all psychotropic substances, including alcohol. For public health, the last of the three statements may be of the greatest significance. There has been very little background information about this statement from the WMA offices which are now located in a French suburb of Geneva. On a broad scale, the most far-reaching recent development in health law in Europe has been the action of the European Economic Community, (EEC), composed of nine of the nations in Western Europe, in removing the legal barriers to free movement and practice of medicine by physicians within the Common Market. The document is officially known as the "Council Directive Concerning the Mutual Recognition of Diplomas, Certifications and Other Evidence of Formal Qualification in Medicine, Including Measures to Facilitate the Effective Exercise of the Right of Establishment and Freedom to Provide Services."3 As in every legal document, one should be careful to read and give significance to every word. One of the cardinal rules of legal interpretation is that there are no superfluous words in a statute. This is true of titles as well as of text. The above title says mutual recognition, not merely reciprocity. We have had reciprocity between American states for years, but not mutual recognition. Under reciprocity, one jurisdiction can retaliate against the other for real or imagined discrimination and the battles of cooperation and competition can go on endlessly. This European document requires mutual recognition. No special provisions can be adopted to apply to one other country in the Nine; recognition of the qualifications must be extended uniformly to all. It should be noted also that the title AJPH February, 1976, Vol. 66, No. 2
PUBLIC HEALTH & THE LAW
bases this recognition on a "right" to establishment and a "freedom" to practice one's profession. These are strong operative words in law. The Common Market Treaty of Rome is based on a philosophy of free movement and free commerce. The individual is given a right under this Directive, not a mere privilege which may be recognized or not by member states. Within the document the basic requirement for recognition of qualification is a total of 5,500 hours of attendance at medical school. No nation in the EEC has less than these hours for graduation from medical school. The member nations are not allowed to impose any quality test on these hours; it is solely a quantitative requirement. Currently the Directive is being reviewed in the member states where the national parliaments are expected to pass the necessary enabling legislation this year. This Directive is the first major piece of health-care-related law-making ever to be adopted by the European Economic Community.
Other cooperative efforts in health law are being discussed in the EEC as well as in the European Free Trade Association and the Council of Europe. These concern such matters as water and stream pollution, patent and copyright laws, pharmaceutical industry matters, and the imposition of strict manufacturers' liability for personal injuries received by users and consumers of products. There is no doubt but that progress is being made in Europe in the movement toward international health law, although there is a great deal yet to be done to achieve uniformity in this field in all areas of concem to the public's health.
REFERENCES 1. WHO Press Release No. 27, 15 August 1975. 2. WMA Declaration of Helsinki, Amendments, October, 1975, Section I, Basic Principles, Section 2. 3. EEC Council Directive, Number 2121 (E.S. 195).
LEGAL TRAINING PROGRAM ON MINOR'S HEALTH RIGHTS ESTABLISHED A Children's Legal Rights Information and Training Program has recently been created at Catholic University in Washington, D.C. In conjunction with this program, faculty will be sent to a variety of locations around the nation to offer custom-made workshops to medical personnel on the legal issues arising in the treatment of minors. These workshops will be given for academic credit and will be individually designed to provide an in-depth study of the laws and cases of each jurisdiction as well as a picture of the legal trends which are developing in the United States. The program will offer training in the areas of: * Child abuse and neglect * Medical care for minors without parental consent * Informed parental consent and privileged communication * Confidentiality between doctor and minor patient * Emancipated minor and health services * Common law and the treatment of minors * Statutes offering minors treatment for VD, drug abuse, abortion, contraceptive care * Mental health and the child * Courtroom practice and procedure for the expert witness. Any agency, institution, or organization interested in finding out more about the program should contact Dr. Roberta Gottesmann, Director, Children's Legal Rights Information and Program Training, National Catholic School of Social Services, Catholic University of America, Washington, D.C. 20017.
AJPH February, 1976, Vol. 66, No. 2
179
