Ethical and Legal Issues

RU 486 in France and England: Corporate Ethics and Compulsory Licensing Reed Boland

and, in 1988, approved for use. The key political incident in this process was the French government’s October 1988 decision to intervene actively with the manufacturer of RU 486-the pharmaceutical firm, Roussel-Uclaf-and force distribution of the drug. The chain of events began in September of that year after the French Ministry of Solidarity, Health, and SocialWelfare announced that RU 486, known under the trade name, Mifepristone, had successfully passed drug toxicity tests when used on a short- term episodic basis and would shortly be approved for marketing and distribution for inducing non-surgical abortions in conjunction with a prostaglandin.’ Aware that RU 486 was in testing stage, anti-abortion forces had already targeted Roussel-Uclaf and its parent firm, the German manufacturer Hoechst, for protests.+ Once it became clear that the drug would be approved by the French government, they stepped up their efforts to prevent it from ever reaching the public. Roussel-Uclaf and affiliated companies were picketed and threatened with boycotts, hostile letters were sent to the chairman of Roussel-Uclaf and other company officials, and French bishops waged a campaign against the drug.5 The drug was described as “a chemical weapon” that would “poison the still tiny children of a billion third world babies.”h So impassioned was the debate that one French commentator invoked the specter of France’s religious wars, speculating that RU 486 might be the cause of new civil unrest aimed at the Catholic Church.7 Such tactics had their intended effect. On October 26 Roussel-Uclaf announced that it would not distribute RU486 because of the public outcry and threats of a boycott.8 Its major stockholder Hoechst A.G. was reportedly particularly upset over comparisons protesters were

Introduction Prospects for the introduction of RU 486 into the United States in the foreseeable future are not good.’ Despite the drug’s proven value in inducing abortion safely and effectively in early pregnancy without the need of surgery or anesthesia and its potential value in the treatment of many other diseases, it has been held hostage by the controversy over abortion. Because of opposition to abortion from the current administration and the threat of boycotts by antiabortion groups, Roussel-Uclaf, the drug’s manufacturer, has expressed its resolve not to become embroiled in the abortion debate and has postponed indefinitely plans to market RU 486 in the United States. The contrast between this situation and that accompanying the introduction of RU 486 into France and England, the two countries where it has so far been approved, is striking.’ Rather than blocking access to RU 486, the governments of these countries moved forward expeditiously with testing and approval of the drug. After expressing initial reluctance in France, Roussel-Uclaf, as well as the company’s English subsidiary, responded to government involvement by committing themselves to cooperate fully in efforts to bring the drug to the public. This article will outline the legal developments surrounding the introduction of RU 486 in France and England and will explore, in the context of American, as well as French and English, law, issues of corporate responsibility for licensing valuable drugs and compulsory licensing.

France The country that has had the most experience with RU 486 is France, where the drug was initially developed, tested, 226

Law, Medicine &Health Care making between it and its manufacture of RU 486 with I.G. Farben, its corporate predecessor, and I.G. Farben’s manufacture of poison gas used by the Nazis in gas chambers in World War 11.9 It also did not want to be forced to determine whether selling an abortifacient was morally defensible or violated the company’s credo to support life. It was at this point that the French government, which owned 36.25 percent of the stock of Roussel-Uclaf,decided to act. Two days later on October 28, it ordered the company to resume plans to distribute RU 486 or face transfer of the license to distribute to other parties.’O As justification for its action it cited Law No. 68-1 on patents, which, under certain circumstances, authorizes the government to grant a license to work a patent to a party that does not have the patent holder’s approval.” The Minister of Solidarity, Health, and Social Welfare declared that the government was taking this dramatic step out of concern for public health and, in language that has been widely quoted, stated that RU 486 was “the moral property of women, not just the property of the drug company.”” Faced with this ultimatum, Roussel-Uclaf agreed to resume plans for distribution, although it subsequently announced that the drug would not be licensed for use in other countries.’? In addition to ordering Roussel-Uclaf to drop its plan to withhold RU 486 from the market, the French government subsequently issued four sets of rules to regulate the use of RU 486. On November 22,1988, it placed RU 486 on a list of poisonous substances destined for medical use, classifying it as a drug that because of powerful effects presents a danger to the public health.14 On December 28 1988, it approved the marketing of RU 486 and established detailed storage, recordkeeping, tracing, and reporting requirements for manufacturers, distributors, and dispensers of the drug.15 Finally, on February 20, 1990, it agreed to pay for approximately 80 percent of the costs of using RU 486.16 This successful effort to force distribution of RU 486, as well as the orders of late 1988 setting rules for the use of RU 486, were met with great hostility by French antiabortion groups and did not escape legal challenge. A number of these groups initiated lawsuits against the actions of the Minister of Solidarity, Health, and Social Welfare, claiming that he did not have legal authority to issue the orders and that proper procedures had not been followed in issuing the orders. They also raised the same arguments that had been unsuccessfully advanced before the Constitutional Court in 1975 against France’s recently liberalized abortion law: that the orders were in violation of the French Constitution and international human rights treaties.’’ Indeed, they viewed the approval of RU 486 as a renewed opportunity to attack the whole practice of liberalized abortion in France. These RU 486 suits were finally decided in late 1990 and early 1991 by the State Council, France’s highest

administrative court, which issued a series of significant rulings. The rulings cut two ways. On one fundamental point they support the position of the anti-abortion groups by holding that the crucial October 28 Order forcing Roussel-Uclaf to distribute RU 486 after it had decided not to become embroiled in the controversy over abortion was made without the proper authority.IXThe Council concluded that under Law 68-1 on patents, cited by the government as the legal basis of its action, the government could not order a drug company to resume distributing a drug and could make an order licensing a party not holding the patent to distribute the drug only with respect to a drug that had already been placed on the market and only when the public health so required because the drug was not being produced in sufficient quantity or with sufficient quality. Since RU 486 was not officially approved for distribution until December, two months after the government’s order to distribute, the Council ruled that the cited provisions of Law 68-1 did not apply to RousselUclaf or RU 486 and the Minister’s order was invalid. At the same time, however, the Council held that the other orders of late 1988 integrating RU 486 into the health care system constituted a valid exercise of administrative authority. First, it dismissed a lawsuit challenging the order inscribing RU 486 on the list of poisonous substances destined for medical use.’9 It rejected the argument that RU 486 could not be classified as a medicine because it was an abortive substance used to destroy unborn life rather than to cure sickness. Instead, it held that the drug fell within one official definition of a medicine, i.e., a substance administered “in order to establish a medical diagnosis or to restore, remedy, or modify the organic functions of human beings or animals.”zo Similarly, it dismissed a number of procedural arguments made against the December orders approving marketing of RU 486 and establishing rules on the dispensing and use of RU 486.“ Most importantly, the State Council rejected the position that the December orders and, in effect, France’s abortion law as a whole, which allows abortions to be performed during the first ten weeks of pregnancy when a pregnant woman is in a “situation of distress,” violated general right to life provisions contained in international human rights treaties to which France is a party.zZAntiabortion groups argued, as they had in 1975, that laws guaranteeing the liberal availability of abortions in early pregnancy were incompatible with the language in the European Convention on Human Rights to the effect that: “Everyone’s right to life shall be protected by law. No one shall be deprived of his life intentionally save in the execution of a court following his conviction of a crime.’’z3They also maintained that French abortion law was incompatible with similar language in the International Covenant on Civil and Political Rights, which France had ratified in 1980, providing: “Every human being has the inherent

Volume 20: 3, Fall 1992

right to life. This right shall be protected by law. No one shall be arbitrarily deprived of his life.”‘4 The State Council disagreed with these arguments and held that the provisions of the abortion law, when “taken as a whole,” were compatible with both treaties. To support its decision, it pointed, as had the Constitutional Court in 1975, to the right-to-life language in the first Article of the 1975 Act itself providing that “the law guarantees respect to every human being from the commencement of life” and to language stating that this principle will only be compromised in cases of “necessity,” according to conditions and limits defined by law. It concluded that this language indicated a common purpose behind the two treaties and the French law. To lawyers trained in the common law and accustomed to the expansiveness of most reported court opinions, these decisions of the State Council on the compatibility of French abortion law with international treaties are not fully satisfying. In the fashion of most French court decisions, they are very short, with only a few, mostly conclusory, paragraphs devoted to each issue raised by the anti-abortion groups. Given the complexity of the issue of abortion, which can involve questions such as whether a fetus is a human being and when does a fetus become viable, the few sentences written by the State Council stating that language in the Abortion Act of 1975 and the international treaties is similar seem inadequate. Although the first Article of the Act supports the principle of protecting human life from the commencement of life, taken as a whole, the Act allows the destruction of “unborn” life on request in the first ten weeks of pregnancy; the Council never addresses this fact, It appears to want to avoid this problematic issue as much as confront it and follows the path taken by the Constitutional Court in 1975 in deferring judgment to the legislature. This approach is in contrast to similar decisions handed down by other high courts, including those of the United States, Canada, and Germany, all of which analyze the questions raised by abortion in far more detaiLzT Given the strong legal arguments for supporting abortion rights, thorough decisions would have been preferable to what the State Council produced.‘6 The brevity of these decisions and the Council’s ruling that the French government had no authority to order Roussel-Uclaf to distribute RU 486 are outweighed, however, by the net result of the four decisions. By January 1991 the issue of how Roussel-Uclaf had been induced to distribute RU 486 was moot; the corporation itself had neither challenged the Ministry of Health’s order, nor expressed an interest in withdrawing RU 486 from the market, and it was proceeding with plans to test and market the drug outside of In fact, Roussel-Uclaf was accused of never having intended to block the distribution of RU 486 and of having acted in collusion with the French government to channel the anger of anti-abortion groups away from the corpora-

tion onto the government.zRThus, the Council’s ruling on this point was, in 1991,of merely academic interest with respect to RU 486. As if to underscore this point, the Council delayed in releasing its decision on this issue until after it had released its other three decisions. Moreover, the other rulings are the most noteworthy to be issued in France since 1975, when the Constitutional Council upheld the constitutionality of France’s liberalized abortion law. They decide an issue that the Constitutional Council declined to address in its 197 5 opinion-the compatibility of the French abortion law with international human rights conventions-and, in rejecting the plaintiffs’ challenge, deprive anti-abortion groups in France of the most potent remaining argument that they had in their efforts to obtain redress through the court sy~tem.~9 Although it survived the legal attacks of anti-abortion groups, the French government’s policy with respect to RU 486 faced one final political test. In early 1991, shortly after the last of the State Council’s decisions was issued, it faced another challenge in the form of an RU 486-related death. A 3 1 year old woman, who was overweight and a heavy smoker in her thirteenth pregnancy, died of a heart attack after being injected with a prostaglandin, the drug that is used in conjunction with RU 486 to induce aborti0ns.3~The death was immediately seized upon by antiabortion activists as reason for banning the use of RU 486.3’ The French government did not take such a drastic step but, instead, issued new rules prohibiting the use of RU 486 by women who are heavy smokers or over 35 years old and modifying the dose of prostaglandin to be administered.+’ While it is questionable whether there is any scientific justification for limiting RU 486 to women who are under 3 5-particularly since the woman who died was 3 I-the line drawn shows that the French government did not succumb completely to the pressures of the moment. Rather, it acted on the knowledge that RU 486 had, since its introduction, been used by some 60,000 women with only this fatality reported.33

England In England, legal activities associated with the introduction of RU 486 have been far less dramatic than those in France. As of early 1992, there have been three developments worthy of note. The first was the initial approval of RU 486 in July 1991, some ten months after RousselUclaf applied for a license.’+The conditions set were similar to those in France: the drug would have to be used within nine weeks of amenorrhea, as opposed to seven in France; women who are over 35 or who are moderate to heavy smokers would be ineligible; and multiple visits would be necessary, including a visit to take the drug, a visit 36 to 48 hours later to have a prostaglandin administered, and a visit for a check-up seven to ten days later.” 228

Law, Medicine & Health Care In addition, the requirements of the abortion law would have to be met: two doctors would have to approve the abortion; one of the required indications for abortion would have to be present; and the drug could not be prescribed by general practitioners or family planning clinics.j6As was the case with the French regulations, English approval of RU 486 was greeted by sharp protests from anti-abortion forces and charges that British women were being used as “guinea pigs.”37 The second development was the December licensing of the first private clinics to perform abortions using RU 486;@ until that time, the July approval of RU 486 applied only to abortions performed in public hospitals. In addition to meeting the conditions set in July, private clinics were required to have one overnight bed available for every woman having an abortion and to provide services only to women who live within an hour’s travel of the clinic, as opposed to two hours in cases involving surgical abortions.39 The need for these further requirements was questioned and it was noted that they were likely to raise the private clinic cost of abortions induced by use of RU 486 to the point where they would exceed the cost of surgical abortions.40 Nonetheless, the licensing of private clinics is of significance because in England almost 70 percent of early pregnancy terminations-precisely those that can be performed using RU 486-take place in private hospitals and clinics. Absent the licensing of private clinics, RU 486 would have been far less available to women desiring to use it. Indeed, the approval of RU 486 gave abortion reform advocates the opportunity to press for changes in the way in which abortions are approved in England. Noting that, because of delays in testing and referral leading to the authorization of abortions, only 20 percent, at most, of all abortions performed in public hospitals are performed within the first nine weeks of pregnancy, critics argued that procedures should be streamlined so that RU 486 could become a realistic option for most women and the anxiety and increased chance of complications accompanying abortions performed after the first trimester could be eliminated.4’ Far less well-known than either of these developments is the fact that the government paved the way for the approval of RU 486 in November 1990with its enactment of the Human Fertilisation and Embryology Act.4‘ This Act, which has been called the most significant to become law in England within the last 20 years$3 is concerned primarily with assisted reproduction procedures and research on embryos. Nonetheless, it contains important abortion provisions, among them one relevant to RU 486. This provision authorizes the government to approve places “in relation to treatment consisting primarily in the use of such medicines as may be specified.”44 What is meant by the term “medicines” is RU 486 and any similar drugs. The

purpose of this provision was to anticipate the approval of RU 486 and other medicinal pregnancy terminations and allow them to be administered in places other than a hospital or similar institution, where by law all legal abortions prior to that time had to be performed. By inclusion of this provision in the Act, the government took account of the fact that, because abortions using RU 486 do not involve surgery or anesthesia, they can be performed in settings that are less fully medically equipped than hospitals.41

Corporate responsibility and compulsory licensing One of the most striking features of the process of licensing of RU 486 in France and England is the fashion in which the governments of both countries became actively involved in bringing the drug to market. The French government not only participated indirectly in the development of RU 486 through its ownership of a significant portion of the stock of Roussel-Uclaf, but ordered the drug to be marketed after Roussel-Uclaf made its decision to withdraw from approval procedures. It withstood the pressures of anti-abortion groups and put the health of women ahead of controversy. Similarly, the English government worked cooperatively with Roussel-Uclaf‘s English subsidiary, Roussel Laboratories, in setting up multicenter trials for the drug and ensuring that licensing requirements were fulfilled. As requested by Roussel as a condition of going forward with licensing in England, it gave its unequivocal support to the company’s activities, when, in March 1990, the Minister of Health rose in Parliament and expressed the government’s endorsement of RU 486.’@Indeed, RU 486 was approved for use in England so quickly-only ten months after application, rather than the usual 19-that some opponents accused the government of placing the drug on a “fast track” for approva1.47 Because of this active involvement of the French and English governments, the drug companies in both countries were either compelled or agreed voluntarily to market RU 486. The experience in the United States has been substantially different. The hostility of the current administration and its Republican allies in Congress to the introduction of RU 486 into the United States and to abortion in general is no secret, and they have taken a number of steps to block access to the drug. In 1989, in response to the prodding of Congressional Republicans, the Food and Drug Administration placed an import alert on RU 486 so that it could not be brought into the United States for personal use..’* In 199I, administration officials delivered an implicit threat to withdraw funding from the World Health Organization by demanding that WHO account for any expenditure of United States funds in WHO’Srole in developing RU 486.49 Most recently, the Bush administration supported regulations drawn up by the Reagan administration that cut off

Volume 20: 3 , Fall 199.2 funds to family planning clinics that even discuss the topic of abortion with their clients and loudly applauded the Supreme Court’s decision to uphold these regulations. While these acts in themselves have not prevented the introduction of RU 486 into the United States, they have, in conjunction with the efforts of anti-abortion groups, created a climate of hostility to abortion such that Roussel-Uclaf and Hoechst A.G. are extremely reluctant to enter the American market.sl As early as 1990, Roussel-Uclaf drew up a list of “mandatory prerequisites” that would have to be satisfied before it would proceed with marketing in any given country. Among them were the requirements that abortion be legal and that local public, medical, and political opinion favor aborti0n.5~At the time, the company expressed its opinion that the United States did not meet these requirements because abortion was not an unchallenged right.33 It also apparently feared a possible boycott from antiabortion protesters54 and announced that it would license RU 486 only in countries requesting the drug.55 In December 1991,at the same time that Congressional hearings on the availability of RU 48 6 were taking place, the spokesperson for Roussel-Uclaf reiterated these views. She stated that the company considered abortion to be a “very controversial issue” in the United States and that Roussel-Uclaf did not want to be involved in the debate.s6 She also expressed “shock” at the regulations cutting off funds for family planning clinics where abortion is discussed. Moreover, she indicated that the threat of boycotts was of major concern to Roussel-Uclaf,~7-a concern repeated by the key developer of RU 486 at the same hearings.s8The result is that Roussel-Uclaf has decided not to apply for licensing in the United States any time in the near futures9 and has, in some cases, refused to furnish supplies of RU 486 for testing and clinical trials, even for use in treatments unrelated to abortion.6o Roussel-Uclafs decision not to apply for a license for RU 486 in the United States and its reluctance to make supplies of the drug readily available to all researchers raise important ethical questions. The first is whether a patent holder has the right to refuse to exploit its patent, thus denying the public the benefit of innovations which are contained in the patent and frustrating the goals of increased scientific progress, which the patent laws were designed to promote. Put another way, does not the granting by the government of a monopoly to a patent holder carry with it the duty to share with the public the benefits of the patent? More seriously, does a drug company have a moral responsibility to facilitate access to a drug or processes that have been unequivocally shown to have significant benefits to public health and have the potential of making even greater contributions if more fully studied and exploited? Further, does not such a company become morally accountable for any suffering that results from its (O

refusal to work its patent? Many countries other than the United States have answered these questions in the affirmative.6’They have placed the public welfare above private corporate rights and have written into their patent laws compulsory licensing provisions. Under these provisions, a party other than that holding the patent is authorized to obtain a license for the patent on a number of grounds, including threat to public health and failure to exploit or insufficient exploitation of a patent within a certain period of time. The French law invoked by the Ministry of Health in 1988 contains both kinds of provisions: a public health provision, held to have been wrongly invoked by the government, which allows the government to grant a compulsory license to a third party when the interest of public health so requires because a drug is not being produced in sufficient quantity or with sufficient and a non-use provision, which allows anyone to apply for a license to market a drug if the patent holder has not exploited or made serious preparations to exploit the patent within three years after it was granted.Q The British patent law contains a similar nonuse provision with the same time limit. It allows a third party to apply for a patent when the patent has not been worked commercially or worked to the fullest extent that is reasonably practicable or where demand for the patented product is not being met on reasonable terms.“ It also authorizes the government to use patented inventions s a result of these provifor “services of the C r ~ w n . ” ~As sions, even if Roussel-Uclaf had refused to apply for a license for RU 486 in England or had defied the French government’s order for it to market the drug, any responsible third party wishing to do so could have applied for a license for RU 486 in both countries on grounds of nonuse and would have had a good chance of success. Although the American patent statute does not contain explicit compulsory licensing provisions, such licensing is not entirely unknown in the United States, particularly in matters of public health and welfare.66Several laws dealing with specialized fields authorize compulsory licensing on these grounds. For example, the Atomic Energy Act of 19 54 allows the Secretary of the Department of Energy to declare any patent to be “affected with the public interest” if its licensing is of primary importance to effectuating the policies of the Act,67 and the Clean Air Act of 1970permits the Administrator of the Environmental Protection Agency to recommend to the Attorney General that a license be granted for a patent reducing emissions if it is not “reasonably available” to prospective licensees.68Various other federal statutes allow the United States government, acting on a theory akin to that of eminent domain, to obtain licenses without the approval of the patent holders?’ In addition, United States courts have granted compulsory licenses in a variety of circumstances when the public interest so demands.70The most common situation

Law, Medicine ei.Health Care involves antitrust violations committed by patent holders.?’ The rationale of the court in granting compulsory licenses in these cases is usually that the patent holder has so far overreached its patent privileges as to intrude impermissibly upon the rights of others and the public protected by antitrust laws.?2Courts have also granted compulsory licenses to government bodies in cases where the public welfare is much more directly threatened than it is by antitrust violations. In City of Milwaukee v. Activated Sludge, Inc.73 a federal court granted a license for use of a patent for irradiating water out of a conviction that public health would otherwise be endangered, and in Bliss v. City of Byooklyn,74 another federal court concluded that public safety was in jeopardy if such a license was not granted for use of a patented fire hose coupling. The compulsory licensing case that is the touchstone for the proposition that patenr laws cannot be relied upon to frustrate the public welfare, however, is Vitamin Technologists v. Wisconsin Alumni Research Foundation.75 Here, the appellee claimed infringement of its patents for processes used to irradiate food and other substances used in food, so as to produce vitamin D, acknowledged by all parties to be a key nutritional element in curing and ameliorating rickets. The appellants, who were producers of oleomargarine fortified with vitamin D, admitted infringing the patents, but argued, among other things, that the patents should not be enforced because the appellee had itself failed to use them to fortify oleomargarine or to license their use to others for the same purpose. They pointed out that the appellants had repeatedly refused requests for licensing and had declared themselves “unsympathetic” to developments relating to the irradiation of oleomargarine. Although the Court ultimately ruled that the patents were invalid on other grounds, it left no doubt that it viewed the appellee’s withholding of licenses for its patents for fortifying oleomargarine as morally reprehensible and as adequate justification for patent infringement by the appellants. It was particularly moved by the fact that oleomargarine was, as it noted, the “butter of the poor”; that the appellee, “a Wisconsin corporation,” was denying licenses presumably to discourage the purchase by consumers of margarine rather than Wisconsin dairy products such as butter; and that, thus, the appellee was contributing to the spread of disease in the poor. It specifically alluded to the strength of the contention that “it is a public offense to withhold such processes [as the appellee’s] from any of the principal foods of the rachitic poor, or, indeed, from those of any such sufferers,” and it concluded that it was “strongly arguable” that suppression of a patent’s use resulting in detriment to the public’s health was “vastly more against the public interest” than antitrust patent To reinforce violations, which courts routinely p~nished.7~ its view, the Court amended its decision after rejecting a request for a rehearing of the case and stated, “We hold

that such refusal to permit such irradiation warrants the refusal of the equitable injunction and accounting relief sought by the corporation. . . .”77 Thus, although the United States, unlike other countries, has not formally codified compulsory licensing procedures in its patent law, there is government acceptance of the concept in other areas of law, as well as ample legal precedent for the proposition that courts can impose a compulsory licensing remedy when the activities of a patent holder seriously threaten the public interest. Indeed, opponents of the introduction of compulsory licensing in the United States invariably point to court decisions ordering compulsory licensing to bolster their arguments that there is no need of formalized legislation.?8 While acknowledging that the public welfare in some cases may demand compulsory licensing remedies, they consider the present powers of the court adequate to fashion an equitable solution in appropriate circumstances. The existence of these powers to fashion compulsory licensing remedies is of great relevance to RU 486 because the drug offers substantial public health benefits. It is not merely an alternative method of carrying out abortions that is interchangeable with existing methods, but a true innovation in medical treatment, whose suppression could adversely affect millions of Americans. It is representative of a new technique of inducing abortion that has significant advantages over existing techniques in that it allows abortions to be performed potentially more cheaply?9 without anesthesia or physical intervention, and at an earlier point in pregnancy.8oThese advantages could make a great difference for women who, because of pre-existing medical conditions, may be at a higher risk than usual of suffering complications from a surgical abortion or second trimester abortions. RU 486 can also reduce the psychological stress experienced by women as a result of abortion by making abortion a less intrusive and more private matter than existing surgical methods do.*’ In addition, RU 486 has a vast potential for treating diseases and conditions other than unwanted pregnancy.8z Some areas of possible application are pregnancy-related, such as contraception, labor induction, and cervical dilation. Others are totally unrelated to pregnancy, such as breast cancer, inoperable meningiomas, Cushing’s disease, endometriosis, and viral infections, including AIDS. Many of these diseases affect significant numbers of people and are difficult to treat successfully with existing therapies. Withholding of RU 486 for research and testing, and ultimately licensing, could result in the continued unnecessary suffering and death of those who have these diseases. In light of the health benefits of RU 486, it is difficult to distinguish between Roussel-Uclaf‘s and Hoechst A.G.’s failure to introduce the drug into the United States and to support fully American research and testing on it and the withholding of vitamin D from the poor condemned in

Volume 20: 3, Fall 1992 Vitamin Technologies. Roussel-Uclaf‘s avoidance of involvement in the debate over abortion and its fears about possible corporate boycotts have resulted in the American public’s being denied vital medical technology unobtainable elsewhere. Given the fact that the performance of abortions is legal in the United States, and will remain so in large sections of the country even if Roe v. Wade is reversed, Roussel-Uclaf‘s position has little justification. It is in conflict with the responsibility of physicians and drug companies to provide the safest and most effective treatments available and could ultimately lead to direct adverse health consequences if antiprogestins such as those about to be manufactured in China are illegally brought into the country and administered without the participation of physicians. Moreover, Roussel-Uclaf‘s position sets a dangerous precedent for other pharmaceutical companies holding patents on potentially controversial drugs. As long as the current administration is in place, there is little possibility that the American government will act as did the French and British governments and take an active role in facilitating access to RU 486. Consequently, under its present corporate policy, Roussel-Uclaf will find little incentive to seek licensing of RU 486. If there is no change in the administration and if Roussel-Uclaf continues to refuse to introduce RU 486 into the United States, prochoice groups should consider marketing RU 486 themselves and bringing a suit against Roussel-Uclaf to obtain a compulsory license. There are, undoubtedly, a number of complex legal issues that will have to be confronted in such a strategy, among them, how to obtain FDA new drug approval and how to procure a legal prostaglandin for administration in conjunction with RU 486 so that the drug achieves its full effectiveness.*3 Nonetheless, the task is worth undertaking, if only to draw attention to the serious problem that Roussel-Uclafs inaction on RU 486 poses.

References I. R.A. Charo, “A Political History of RU-486,” in K.E. Hanna, ed., Bio-Medical Politics (Washington, D.C.: National Academy Press, 1991), 77; M. Klitsch, “Antiprogestins and the Abortion Controversy: A Progress Report,” 23 Family Planning Perspectives 275 (1991). 2. In addition, it has been reported that the Chinese government has approved RU 486. The New York Times, September 24, 1988, Section I, p. I; Chicago Tribune, September 27, 1988, P. 4. 3. The New York Times, October 29, 1988, Section I, p.1 and February 12, 1989, Section 6, p. 23; Newsday, May 29, 1989, p. 5 and April 24, 1989, p. 31. 4. Charo, supra note I, at 54-59. 5. The New York Times, 12 February 1989, supra note 3; Newsday, 29 May 1989, supra note 3; Reuters Library Report, October 28, 1988. 6. The New York Times, February 12, 1989, supra note 3. 7. Sunday Telegraph, 30 October 1988, p. 9. 8. The New York Times, supra note 3.

9. The New York Times, 10.The

1 2 February 1989, supra note 3 . New York Times, supra note 3; Le Monde, 30

January 1991. 11. Code commerce, Brevets d’invention, Section 37. An English translation of this law appears in 78 Patent and Trademark Review 417 and 464 (1978). 12.The New York Times, supra note 3. 13. The New York Times, March 26, 1989, Section 4, p. 18; United Press International, March 24, 1989. 14. Order of November 22, 1988. Journal oficiel, December 16, 1988, p. 15713. 15. Authorization of December 28, 1988 and Order of December 28, 1988. Journal oficiel, January 12, 1989, p. 465. 16. Order of February 20, 1990. Journal oficiel, February 2 5 , P. 2542.

17.Journal officiel, January 16, 1975, p. 671. 18. Order of 2 5 January 1991. Revue fraqaise de droit administratif 292 (1991). 19. Order of November 19, 1991. Revue francaise de droit administratif 321 (1991). LO. Code de la Sant.4 Publique, Article L.5 I I . 2 1 . Orders of December 21, 1990. Reme francaise de droit administratif 208 (1991). These arguments included the following: a ) that the Minister of Health had no authority to regulate RU 486 under the Code of Public Health; b) that the person who actually signed the order approving RU 486 had not been properly delegated to d o so by the Minister of Health; c) that the Minister of Health was required to submit proposed regulations on RU 486 to national councils of physicians and pharmacists; d ) that the timing of the order approving RU 486 was irregular; e) that instructions on the use of RU 486 were not sufficiently precise to preclude misuse of the drug; f ) that regulations on the distribution of RU 486 violated legal provisions prohibiting the offering or sale of substances that can provoke abortion; and g ) that instructions calling for women using RU 486 to be informed that, if this method of abortion fails, they run the risk of giving birth to a deformed fetus should they carry the pregnancy to term, violate legal provisions prohibiting “propaganda” in favor of abortion. 2 2 . Law No. 75-17 of January 17, 1975 uournal officiel, January 18,1975, p. 739), reenacted and amended by Law No. 79-1204 of December 31, 1979 (journal oficiel, January I , 1980, p. 3). The determination of what constitutes a “situation of distress” is left to the woman. Abortions can be performed later in pregnancy if two physicians certify that the pregnancy poses a serious danger to the woman’s health or the fetus is suffering from a serious disease or condition. 23. Convention for the Protection of Human Rights and Fundamental Freedoms, Article 2. 213 U.N.T.S. 2 2 2 . 24. International Covenant on Civil and Political Rights, Article 6. 999 U.N.T.S. 172. 2 5 . Roe v. Wade, 410 U.S. 113 (1973); R. v. Morgentaler, [1988] I S.C.R. 30 and Tremblay v. Daigle, lr989l 2 S.C.R. 530; Judgment of February 25,1975,39 BVerfGE I . 26. For example, a strong argument can be made that the right to life provisions in the international treaties invoked by the anti-abortion groups in these cases were never intended to apply to fetuses, but, instead, were intended to apply exclusively to criminal proceedings brought against living persons. 27. 265 Journal of the American Medical Association 1628 (1991). 28. The New York Times, supra note 3. 29. The State Council decided to make a ruling on this issue because, between the time of the Constitutional Council’s decision in 1975 and 1990, intervening jurisprudence had held that

Law, Medicine ej. Health Care 50. Rust v. Sullivan, 11 I S. Ct. 1759 (1991);The New York Times, May 24, 1991, Section A, p. I 51. It is not entirely clear which branch of the Hoechst pharmaceutical company is the source of the greatest opposition to the introduction of RU 486 into the United States. The parent company Hoechst A.G. expressed its discomfort with the drug at least as far back as 1988 when it contributed to Roussel-Uclafs initial decision not to market the drug in France (The New York Times, supra note 3 ) , and the drug’s key developer has been quoted as saying that Hoechst fears a boycott of its United States products, which earn substantial profits for the company. Reuters, July 31, 1990. Others believe that the strongest opposition to RU 486 is coming from Hoechst’s United States subsidiary Hoechst-Celanese, said to have been “influential” in Hoechst’s decision not to introduce RU 486 into the United States. PR Newswire, January 21, 1992; United Press lnternational, January 22, 1992. Whatever the case, it has been left to Roussel-Uclaf to voice publicly corporate concerns about RU

French courts did have jurisdiction to hear cases arguing that French law violated the provisions of international conventions to which France is a party. Judgment of the Constitutional Council of October 21, 1988 (Recueil des de‘cisions du Conseil Constitutionnel, 1988, p. 183) and Judgment of the State Council of October 20, 1989 (Recueildes d&cisionsdu Conseil d’Etat, 1989, P. 190). 30. Le Monde, April 10, 1991 and April 23, 1991; The New York Times, April 21, 1991, Section I , Part I, p. 3; Chicago Tribune, April 21,1991, p. 24. 3 I. United Press International, April I I, I 99 I . 3 2 . Supra note 30. 3 3 . Ibid. 34. The Independent, July 4, 1991, p. 4; The New York Times, July 4,1991, Section A, p. 7 ;Press Association Newsfile, July 23,1991. 3 j. The Independent, supra note 34; Roussel Laboratories Ltd., Denham. “Press release: U.K. approval for mifepristone” (July 1991).In France four visits are required: one to request the abortion, another to confirm the request and receive RU 486, a third to receive prostaglandin, and a fourth for a check-up. See R.J. Cook, “Antiprogestin drugs: Medical and Legal Issues,” 21 Family Planning Perspectives 267 (1989)at 268-269. 36. The New York Times, supra note 34; The Independent, supra note 34; The Chicago Tribune, July 4, 1991, p. 2. An abortion may be performed within the first 24 weeks of pregnancy if two registered medical practitioners are of the opinion formed in good faith that “the continuation of the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman or any existing children of her family.” Abortions may be performed later in pregnancy for serious health reasons, including risk to the life of the pregnant woman, or if there is a substantial risk of the birth of a seriously handicapped child. The Abortion Act 1967, as amended by The Human Fertilisation and Embryology Act 1990. 37. Press Association Newsfile, July 16, 1991 and supra note 34; The Times, July 17, 1991; The New York Times, supra note 34. 38. The Independent, December 8,1991, p. 11. 39. Ibid. 40. Ibid. 41. The Times, July 9, 1991 and July 22, 1991; The Daily Telegraph, July 16, 1991, p. 1 5 42. Human Fertilisation and Embryology Act 1990. 43. D. Morgan and R.G. Lee, Blackstone’s Guide to the Human Fertilisation and Embryology Act 1990 (London: Blackstone Press Ltd., 19911, vii. 44. Human Fertilisation and Embryology Act 1990, Section 37 ( 3 ) . 45. It should be noted that, as of early 1992, no other such places have been approved for abortions and there seemed to be little possibility that they would be given the concern of Roussel Laboratories over security of drug supplies and safety. See Roussel Laboratories Ltd., supra note 3 5 . 46. E.E. Baulieu and M. Rosenblum, The Abortion Pill (London: Century, 1 9 9 1 )114. ~ 47. Press Association Newsfile, supra notes 34 and 37. 48. Charo, supra note I; Cook, supra note 35, at 269. 49. The New York Times, April 10,1991, p. zj. A representative of the Bush administration also warned the World Health Organization of “negative consequences” if it continued research on RU 486. United Press International, June 29, 1991. This threat was subsequently withdrawn under international pressure.

486. 52. The New York Times, July 29, 1990, Section I , Part I, p. I; Klitsch, supra note 3, at 279; R.M. Baum, “RU-486: Abortion Controversy in U.S. Clouds Future of Promising Drug,” Chemical and Engineering News, March 11, 1991, p. 9. The other conditions were that a synthetic prostaglandin be locally available, that the distribution network be strictly controlled, and that patients be required to sign a consent form. 5 3 . Ihid. 54. Ibid. 5 j.Charo, supra note I, at 46. 56. The Washitzgton Post, December 10,1991. p. 27. 57. The New York Times, December 5 , 1991, Sect. A., p. 22.

58. Reuters, December 5 , 1991; See also, The New York Times, supra note 52. 59. The Washington Post, supra note 56. 60. The New York Times, 16 November 1990, Sect. A, p. z and supra note 57; Baum, supra note 52, at 11-14; “Commentary. Beyond ‘Abortion’: RU-486 and the Needs of the Crisis Contingency,” 264 Journal of the American Medical Association 1026 (1990). Some saw Roussel-Uclaf‘s recent approval of a Canadian trial of RU 486 for the treatment of breast cancer, rather than proposed trials in the United States, as the latest evidence of the company’s reluctance to supply American researchers. The New York Times, supra note 57; The Washington Post, supra note 56; Roussel-Uclafs spokesperson, however, denied that this was the reason that the company had not approved the proposed American trials. Ibid. Moreover, in January 1992 Roussel-Uclaf sent an official letter to the Food and Drug Administration confirming that the company “fully agrees to help U.S. investigators to perform clinical studies with RU 486 (Mifepristone).” As conditions for cooperation it required that a) the studies not relate to abortion; b) the protocols be medically and ethically acceptable; and 3 ) the investigators comply with FDA rules and internal Roussel-Uclaf procedures as regards reporting of side-effects,publications, and other matters. Letter of January 2,1992, from AndrC Ullmann to Dr. Solomon Sobel, Director, Division of Metabolism and Endocrine Drug Products, Food and Drug Administration. 6 1 . H. Schade, Patents at a Glance:A Survey of Substantive Law and Formalities in 50 Countries (Koln: Heymann, r y 8 0 ) . 62. Code de commerce, Brevets d’invention, Article 37. 63. Ibid., Sections 32-33. 64. Patents Act 1977, Sections 48 and 5 3 . Section 48 establishes additional grounds for compulsory licensing relating to commercial availahility of the patented product and other prod-

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ment to its decision it forcefully condemned the University of Wisconsin, which it considered to be the chief villain in the case. It noted that the University had used its great influence to obtain from the appellee an agreement to refuse licensing of its process for the irradiation of oleomargarine at the time that the appellee was assigned the patent by one of the University’s professors, who had initially secured it. 78. See APLA Quarterly Journal, supra note 66, at 157, 182-183, 197-198, 205; Lauroesch, supra note 66 at 56. 79. See I. MacKenzie, “The Potential Effects on NHS Resources,” in The Abortion Pill (MifepristoneIRU 486): Widening the Choice for Women, London: Birth Control Trust, 1991), 41; Charo, supra note I, at 45. 80. Abortions using vacuum aspiration are usually performed about six weeks following a missed period, while abortions using RU 486 can be performed as soon as one day after a missed period. 81. D.R. Urquhart and A.A. Templeton, “Acceptability of Medical Pregnancy Termination,” z The Lancet 1 9 8 8 ~p. 106. 82. For descriptions of these diseases and conditions see Klitsch, supra note I; A. Ullmann, G. Teutsch, and D. Philibert, “RU 486,” 262 Scientific American, 42 (1990); “Commentary. Beyond ‘Abortion’: RU-486 and the Needs of the Crisis Contingency,” supra note 60. 83. Until very recently, introduction of RU 486 into the United States was in one sense only a theoretical possibility because there was no prostaglandin on the American market that had been tested for use with the drug. This situation was rectified in the spring of 1992 when the French government approved the prostaglandin Cytotec for use with RU 486. Cytotec has been licensed in the United States by the FDA for use as a treatment for ulcers. Despite this fact, however, it is not known whether Cytotec’s manufacturer will approve use of its drug in conjunction with RU 486 for terminating pregnancies and whether legally it can so be used without the warning that its use is contraindicated for pregnant women. Although the drug’s manufacturer agreed to change this language in France so that Cytotec could be used with RU 486, it may be more reluctant to do so in the United States where opposition to abortion is much more vocal. Similarly, there are difficulties involved in obtaining new drug approval from the FDA for a drug whose patent is held by a party other than that applying for the patent. Under 1984 amendments to the Federal Food, Drug, and Cosmetics Act ( 2 I U.S.C. Sect. 505), a party not holding the patent of a drug and not relying in its application on investigations it has performed itself can submit an application for FDA approval if it claims that the patent is invalid and gives notice to the patent holder of its intentions. The patent holder then has 45 days within which to bring a case of patent infringement or lose the right to oppose FDA approval of the drug. If the patent holder does bring a suit, theoretically, a party seeking FDA approval could at that point assert that a compulsory license be granted to it for reasons of public health. However, potential problems may arise around obtaining the proper investigation results for an application and convincing a court that the patent is invalid within the meaning of Sect. 505.

ucts that may rely on the use of the patented product. Moreover, Section 5 I of the Act allows compulsory licensing when a patent is involved in monopolistic or anti-competitive practices. 65. lbid., Section 5 5 . 66. For discussions of the issue of compulsory licensing in the United States see “Comment, Compulsory Licensing in the United States: An Idea Whose Time Has Come,” 8 NorthwesternJournal of International Law & Politics 666 (1988);M.W. Lauroesch, “General Compulsory Licensing in the United States: Good in Theory, but not Necessary in Practice,” 6 Santa Clara Computer and High Technology Law ]ournal 41 (1990); z APLA Quarterly Journal (1974), which is entirely devoted to compulsory licensing. 67. 42 U.S.C. Section 2183. 68. Clean Air Act of 1970,42 U.S.C. Section 7608. See also the Plant Variety Protection Act, 7 U.S.C. Sections 2402-2404 for another example of compulsory licensing. 69. Coal Research and Development Act, 3 0 U.S.C. Section 666; Helium Act, 50 U.S.C. Section 167b; Tennessee Valley Act, 16 U.S.C. Section 183r; 28 U.S.C. Section 1498. 70. One United States case, Foster v. American Machine & Foundy Co., 492 F.zd 1317 (1974),has held that a compulsory license can be granted without a finding of harm to the public welfare simply because a patent holder has not worked its patent. Although the Supreme Court let the decision stand by denying certiorari, the general view is that the holding of the case is an anomaly because it appears to be in conflict with the Supreme Court’s own precedents. Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U.S. 405 (1908); Hartford-Empire Co. v. United States, 3 2 3 U.S. 386, clarified in 324 US. 570 (1945).See the discussions in APLA Quarterly Journal, supra note 66. 71. See Walker Process Equip., lnc. v. Food Mach. & Chem. Corp., 382 U.S. 172 (1965); Hartford-Empire Co. v. United States, supra note 70; United States v. United States Gypsum Co., 340 U.S. 76 (1950);Staff of the Subcommittee on Patent, Trademarks, and Copyrights of the Senate Committee on the Judiciary, 86th Congress, zd Session, Report on Compuls o y Patent Licensing under Antitrust Judgments, 1960, p. 5 ; Moore, “A Study of Compulsory Licensing and Dedication of Patents as Relief Measures in Antitrust Cases,” 24 George Washington Law Review 223 (1955). 72. Hartford-Empire Co. v. United States, supra note 70. 7 3 . 6 9 F.2d 577 (1934). 74. 3 F. Cas. 706 (1871). 75. I46 F2.d 941 (1945). 76. At this point in the opinion, the Court discussed the Supreme Court case, Continental Paper Bag Co. v. Eastern Paper Bag Co., supra note 70, the main precedent for the view that a corporation generally has the right to suppress the use of a patent that it holds. It noted that in Continental Paper Bag suppression of the use of the patent was not found to be against the public interest, and that the Supreme Court expressly left open the question whether such suppression might be unenforceable in a case where it was against the public interest. 77. It is interesting to note that the Court raised on its own the public health aspects of the appellant’s claim with respect to withholding licenses for its patents. In addition, in its amend-

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