Souvenir 1995

For many decades it has been known that fall in birth rates accompanies rising standards of living, fall in infant mortality rate and rise in women’s education levels. In other words, population adjusts itself to the circumstances under which people live. When left to fend for themselves people are forced to seek personal solutions to problems such as old age security or need for working hands through having more children and even sons.

Yet the formula adopted by the population control establishment is quite at variance. To begin with, it was assumed that there was an unstated demand for contraception and if this demand was met it would result in the lowering of birth rates. Inundation thus became the strategy. This failed. Rather than learning from this experience other strategies were tried which were akin to business management strategies-targets, incentives, disincentives, media promotion: but all dependent on solving social problems with contraceptive technology.

The preoccupation with high birth rates favoured the adoption of technology which had a high theoretical effectiveness. For example, diaphragms and spermicides which could be adopted even with a low level of service delivery were discarded in favour of hormonal pills which required extensive screening as well as continuing follow up. Pills found favour with pharmaceutical companies because of profits which could be generated with a consumable product and with the population control establishment because of a theoretically high level of effectiveness. Similarly, intra uterine devices (IUDs) were adopted wholesale for family planning programmes. Women, however, rejected these highly ‘effective’ methods which compromised their health and fertility. In the case of pills, inadequate monitoring and supply logistics compounded the problems. Yet there was no attempt to improve health services. Rather the conclusion drawn had a distinct race, class and patriarchal bias. Population planners concluded that poor women from the Third World could not be trusted to be active agents in controlling their own fertility because practice showed them to be poor acceptors of contraceptives.

Safety Vs Effectiveness

Safety standards for contraceptives are premised on some sort of a trade off between safety of contraceptives and existing high rates of maternal mortality. This argument is also used by expert bodies like the WHO. In doing so these protagonists of effective contraception forget that maternal mortality is an avoidable death which is largely dependent on the health status of the mother and the outreach of health services. High prevailing rates of maternal mortality are in fact used to lower the safety requirements of new contraceptives. Hormonal methods which have known side effects such as blood clotting and heart disease which can spell death for women who are not in easy reach of a health care system, are promoted freely. It is not as if these side effects occur rarely. To cite just one instance, a study of the injectable Net-En on four women at Hyderabad produced clotting disorders in three and had to be abandoned. As it is, there is little logic for women to choose between death due to contraception and that due to maternity. The seriousness of this becomes clear when we find that in the US, modern contraceptives have replaced maternal mortality as a cause of death. Better obstetric care has ensured that women do not die of child birth and abortions while increased usage of contraceptives such as the oral pill has caused the death of young women due to heart disease and strokes, a problem which most others would encounter only in their old age.

That women ought to have any understanding about the functioning of their own bodies and know their well-being does not merit any consideration in developing contraceptive technology. Instead, technology now seeks to disempower women by taking control away from them to place it in the hands of the medical establishment. With these come methods which are long acting, invasive and require the mediation of doctors for any change in decision.

There is a distinct bias in contraceptive research which ignores the well being of women in the South. Only 10% of the research funds are allocated to research on safety which are nearly all spent on women from the North. For the rest of the world only two questions are of importance – firstly, is the contraceptive effective and secondly, do women continue to use it after they adopt it. Studies on side effects are important only so far as these constitute the reason for women to discontinue use.

Who Gains?

Fall in the standards of safety requirements benefitted the multinational drug companies of the North. Stringent pre marketing testing requirements for contraceptives in the North had earlier led to a situation where patents would be nearing expiry by the time the product came to the market. Therefore these companies had to look for global markets to maintain profitability. By entering into profit sharing agreements with the WHO, which was publicly known as a neutral scientific body, these companies succeeded in influencing drug proliferation in the South because WHO also took on the role of coordinating and conducting research. This alliance with drug companies led to anomalous situations where drugs considered second rate even within the originating countries, such as the ruling of the German authorities for Net-En, were put on the much respected essential drug list of WHO. Incidentally, Net-En is only meant for such women in the North who cannot be trusted to used any other contraceptive reliably (a euphemism for residents of mental asylums), or need one time contraception. In direct contrast, in the South it is prescribed as a spacing method and provided to ordinary women.

Such double standards led to a situation where women from the North were getting no new contraceptives whereas in the South women were being glutted with products of dubious value. This situation only started changing with the introduction of Norplant where the new drug application put up before the USFDA clearly indicated that the reason for seeking approval was the ease with which a drug approved in the US could be introduced elsewhere. In the eighties another shift took place with the private companies spending less on new product development and the US government funding NGOs to carry out research. In the nineties the shift appears to be one of the North trying to wash its hands off the dirty research altogether – now the research is being done in the South with funds from the North. So that unethical trials, unsafe products, and hasty conclusions can all be blamed on the scientists of the South whereas the funds continue to flow from the North. One such concrete example is the anti-hCG vaccine being developed in India which has come under severe criticism by the WHO and other North dominated agencies, even though the product patent is with IDRC of Canada which is also continuing to fund this unethical research despite protests from the scientific community as well as women’s organizations the world over.

The US government is the biggest funder of contraceptive research and most of the technologies in wide use today have been developed in the US. Nor should one get confused about the ultimate beneficiaries of all this research being now carried out by the NGOs which may enjoy a better reputation than some of the notorious private concerns. After all, contraceptives developed in this sector will also be produced and marketed by the same drug companies who are now spared the expense of the R&D.

Research - who does it?

WHO has played a big role in guiding and carrying out research on contraceptives. Manufactures and inventors are also a party to the research and so are the bodies like the National Institute of Immunology, Indian Council of Medical Research (ICMR), Central Drug Research Institute etc. In India most of the contraceptives have been researched into by the ICMR in its Human Reproduction Research Centres (HRRCs) set up with the help of WHO. Studies have not only been coordinated nationally but also internationally. As such funds for these, either in the form of devices or drugs, have also been provided by the manufacturers. While manifestly it appears as if two out of the three parties involved have independent motives for carrying out research there exists a lot of documentation to show that these bodies have interlocking boards. In her analysis Sumati Nair also found this in the case of research on Net-En, 19 out of the 21 pieces of research were directly supported by the manufacturer Schering AG. WHO is not only governed indirectly but as an organization is party to agreements whereby the research sponsored by it brings in profit if, as a consequence of research, the contraceptive is approved for use in governmental programmes.

In the past at least this research was being done at several different centres and provided useful information from mutually contradictory results. Increasingly the role of developing new contraceptives has been taken over by NGOs or Government Institutes originating in the US. For example, the Population Council has carried out most of the research into Norplant. Needless to say, the tracks are much better covered.

In the Population Summit of the World Academy of Sciences held in 1993 at New Delhi, India the participants raised this issue, and said that for contraceptive research to have better credibility the compounds should be freely available to all those who wish to do research so that results can be authenticated or falsified as the case may be.

Women’s resistance to imposed contraception

A large number of women who do not wish to have children resist using contraceptives even when they are available free of cost. They prefer to take their chances with back street abortions. This is because contraceptive technology has not really taken in to account the needs of women. Indian experience with the Lippes loop is a case in point. In the sixties, this IUD was promoted without even ascertaining the period for which it could be left inside the uterus. Stories about it spread faster than its adoption. The Indian government deemed it fit to work out the operational aspects of IUD administration a full four years after it had been used extensively in the family planning programme. This did not happen because the government suddenly developed a concern for women’s well being but because women started rejecting the device due to bleeding problems, infections, and contraceptive failure.

The users have different considerations. Though women have consistently shown in limiting family size, the risks they are willing to take for this vary considerably. Even today, in India a woman finds a stable place in her matrimonial home only after she has produced a son. High acceptance of permanent methods suggests that once the women are ready to give up their fertility they are ready to subject themselves to sterilizations in theatres full of flies.

The question of return of fertility is the other count on which women in countries where child bearing is highly valued find themselves at variance with contraceptive technology developed with an anti-natalist bias. Return of fertility subsequent to contraceptive use is not ever studied fully. The studies which are carried out lack rigour. In India, in a bid to introduce Net-en, a return of fertility study was carried out. The study did not even make clear the duration for which women had used this contraceptive and failed to note the outcome of the pregnancy. It compared the results with the faulty control of women whose fertility had been impaired by using an IUD to conclude that Net-en had demonstrated a good return even as half of the women suffering from amenorrhoea (absence of menstruation) during Net-en use failed to conceive.

Ethics, protocol…and related matters

All ethics in bio-medical research on human beings suggest free informed consent as a precondition for enrolment of volunteers. In India this ethic is absent. For more than ten years we have been aware that women are not even told that they are a party to an experiment. During Net-en trials in 1984 it was used as one of the methods at a family planning camp. An advertising leaflet replaced informed consent and suggested that Net-En was a miraculous contraceptive and that it enhanced the supply of breast milk. This state of affairs has not changed even now. The last encounter with researchers has been in the case of Norplant in 1995, where till the last minute women were blissfully unaware that they were a part of a trial. Informed consent apart, outright coercion is still being exercised in recruiting women for trials when they approach health services for abortion.

Spreading misinformation among users is equally common. Even today, women being recruited for Norplant trials are told that they may suffer bleeding disturbances but those would be taken care of. The field staff are ill-informed. For instance, the protocol for Norplant lists bleeding disturbance as an inconvenience, not even as a side effect and fails to mention Population Council’s long list of central nervous system, metabolic disorders etc. Naturally, they cannot inform women of potential complications.

So, if we consider the contraindications and the violations of this limited protocol, it is frightening to think of what happens to the poor women who are fooled into participating in trials. Protocol violation can be as gross as reported in a court affidavit by the researchers themselves – which suggest that all volunteers were given the shot on a single day for Net – En. It is extremely unlikely that for all these volunteers it could have been the first week of their menstrual cycle as required by the manufacturer.

Volunteers are not provided any risk coverage but are paid substantial sums as transport reimbursement which makes them continue in trials. For anti-fertility vaccines women were given around 500 rupees per month to keep appearing at the hospital for blood tests etc.

Examples of this kind abound, particularly in case of provider dependent methods where women are coerced or cajoled into continuing with the study. India is not unique in this respect, these stories are repeated everywhere because trials are primarily conducted on disadvantaged sections of the society. One glaring example is of Norplant use in Indonesia as reported in an evaluation

Marketing Strategies

The key concern is with making the contraceptives acceptable. For this purpose acceptance is treated as a marketing variable and a lot of effort goes in packaging the product right. Medical and health issues fade into the background. Among the marketing strategies used are the contraceptive choice or the cafeteria approach and the setting of targets with respect to each method.

The target achievement approach has to do with the level of certainty the government wishes to have in contraceptive prevalence. With this approach the level of user satisfaction takes a further back seat if such thing is even possible. The target of contraceptive prevalence is not just accidentally set in terms of equivalent sterilizations. Sterilization is the dream of population controllers with the absolute certainty that no birth is going to take place. No one is oblivious to the fact that the level of rural health services is such that health workers have no time to go to couples again and again to keep them motivated to use contraceptives. The stress is then on long acting provider controlled methods ranging from IUDs to injectables to implants and now the vaccines.

The lack of acceptability has also not led to research on making methods or method provision more responsive to women’s needs but to developing methods which are packaged right. If husbands posed a problem the solution was sought in finding methods which the husbands could remain ignorant of. If women militated against side effects, counseling in the guise of medical guidance made them believe that these were minor and not really anything to worry about, as was the case of dealing with bleeding disturbances and migraines caused by the use of long acting progestogen-only contraceptives. Not only this, amenorrhoea (an indication of endometrial atrophy) is heralded as a benefit for anaemic women because it means no menstruation. Needless to say, that this guidance has no basis in scientific research. Till date the scientific community has no proper explanation or treatment for these side effects.

Reproductive rights indeed!

We live in a strange country. Over half the population is unable to get two square meals a day in this land of food sufficiency. Women have to walk miles everyday to fetch water. Millions live in makeshift shelters and footpaths. Yet these needs are not the constant concern of the planners. In fact, quite to the contrary, the architects of liberalization are asking these very deprived Indians to tighten their belts and prepare to enter the era of globalization.

In this context it is strange that the whole world is ready to focus on the reproductive rights of women and make sure that they have a whole cafeteria of contraceptives available to them. Women’s contraceptive are first being defined and then being fulfilled constantly by the government, donor agencies and pharmaceutical companies. In this process women do not have any voice. Contraceptives and sterilization services reach those places where basic health services are not available. Planners of this country show single minded concern to meet the contraceptive needs of women who incidentally, also need food, shelter, water, clothes, education, health services, gainful employment, child care services, legal rights, love and dignity.

Individuals have no fixed and inherent demand for contraceptives but a need to have control over fertility. The control can be gained also by abstinence, breast-feeding as well as through alternate forms of sexual expression. But this does not generate any demand for contraceptives. It also requires mutual care and cooperation and back up abortion services and awareness of the functioning of ones’ own body. It is not uncommon to find relationships where couples have known about various contraceptives but have not used them and yet have only the desired number of children.

Women’s needs for contraceptives vary tremendously. These range from the extreme of those women who do not want a birth at any cost to women who merely want to postpone having a child. It may be the need of a teenager or it may be the need of a woman nearing menopause. It may be the need of a woman who wants to bring an end to her fertility altogether. It may be the need of a healthy woman or of one who is suffering from some chronic illness. It may be the need of a breast feeding woman. It may be the need of a woman in prostitution or of a woman in a long standing marriage, a young woman engaging in sex for the first time or of a woman who has sex very infrequently. It may be the need of a woman who has no knowledge of her body’s functioning or that of a woman who knows when she needs protection. It can be the need of a woman who is extremely fertile or that of a woman who finds it difficult to conceive. It may be the need of a woman who has a cooperating partner. One can go on endlessly, but the point is that all women need different kinds of contraceptives and are willing to pay different costs to prevent pregnancy. Not only this, contraceptives may have different implications and the cost of any particular technology will be different for different women.

Needless to say the Indian Family Planning Programme limits itself to women living in long standing relationships. The defined focus is then on child spacing and sterilization.

Contraceptive technologies such as NORPLANT cost around Rs. 2000 per set which incidentally is also the medicine budget for a year for a sub health centre. Depo Provera will cost Rs 4000 per year per user. For ten such contraceptive users the government can provide a source of potable water in the village, or open a primary school or for that matter start an income generating project.

Women’s organizations are under attack for opposing further additions to the existing cafeteria. But no one else has asked women what they would like to do with such a large amount of money. Their response can be easily predicted. How worthwhile is a contraceptive cafeteria with all the sophisticated devices when women do not even have the choice to get two square meals a day or for that matter life saving drugs for their children.

Animal Models

Two of the highest selling injectable formulations, namely, Depo Provera and Net-en showed extremely poor responses in animal models which were being used all along to determine the safety of drugs in humans. After a long scientific debate, The WHO pronounced animal models to be irrelevant for research on hormonal contraceptives rather than discarding the products in questions. It is worth mentioning here that long term studies on animal studies are carried out on all drugs to predict their safety for use by human beings. These studies are crucial for contraceptive drugs because they are used by a large number of healthy women over long periods of time. Since 1987 the WHO-HRP is on record to say that population problems of the South are pressing enough to avoid carrying out animal studies and instead post marketing surveillance is good enough. In other words, with this pronouncement the WHO has turned the women of the South officially into guinea pigs. For this action of sparing animals from cruelty of scientific experimentation the WHO also received an award from animal lovers.

Strategies and Outcomes

Our experience of resisting the onslaught of these technologies dates back to a petition before the Supreme Court in 1986 seeking a stay on the introduction of Net-En. While this legal strategy was chosen to prevent unethical recruitment to trials, we were and are well aware of the propaganda for population control which has a history of four decades in this country and has completely shaped the minds of all who are in a position of authority. Given this it was worthless to confine this petition to the question of violation of civil rights and medical ethics. Hence we started to look closely at the safety record of this drug. This was a process of discovery where we realized that the entire safety record was based on contradictory interpretations as well as misrepresentations. Needless to say that our arguments could not be refuted in the court by ICMR, the Drugs Controller of India and the Government of India put together, in their replies.

But all in all, the petition managed no small feat, it stopped the introduction of Net-En into the Government Family Planning Programme. It also prevented the marketing of Net-En for nearly nine years even though this petition is still pending final decision.

With Norplant the strategy adopted turned out to be completely at variance. By now we already had more than four years of inaction by the court. Also, the government had threatened a gigantic trial involving 20,000 women to start within two months of its first pronouncement. This meant that if we had to stall these trials we could not wait for court orders. Further, Norplant had already exposed itself as a contraceptive with a high potential of abuse. While unethical trials were a major issue for the Net-En case, in this instance, Phase III trials were being bypassed to proceed straight for a pre-programme introduction study. The cost of the device, and its requirement of surgery were not going to be without strain for the public health system which was already reeling under the impact of structural adjustment. We therefore had to take a hard political stand of saying no to trials. We had to ensure that we were not alone in this task and had to involve other women’s organizations in the process.

Two dangerous trends that started in India by this time: One was the increasing power and influence of donor agencies such as the UNFPA and the Ford Foundation on the government establishment, and the other, of slow cooption of NGOs in the family planning programme. This implied that within the so called alternate circles also unless we increased our outreach, there was a greater chance of their being indoctrinated in the false progressive language of population control. The formal effort to seek new allies started in January 92 and by February ’92 other women’s groups and 18 mass organizations were with us against Norplant. At some level we started seeing the need to take the issue to women who were going to be affected by these technologies and this was done using a leaflet and a street play.

While our appeal to the Minister went unanswered, we were able to get the trials scaled down to 1000 women with the active intervention of the National Commission for Women. But the ICMR acted in a most unscientific manner and expanded the trials mid way to include twenty more centres. In Delhi at least for the first six months the recruitment was relatively ethical, i.e., women coming to the hospitals were not coerced into adopting Norplant. However, with clean cases it was impossible for the centres to reach the desired number of subjects and then malpractices came into being.

While we managed to stir up quite a few events opposing Norplant and managed to get widespread support for our demands, the opposition to other hazardous technologies has not been so consistent. RU-486, an abortifacient pill undergoing clinical trials right now, has not been properly investigated by us nor opposed systematically. Fortunately, the anti-fertility vaccine of the National Institute of Immunology has become the target of an international campaign. But it was the sudden licensing of Depo-Provera which gave us a rude shock.

In October 1982, this drug was approved in the US for use as a contraceptive in an unprecedented manner with the USFDA asking the company to apply afresh for licensing, in the wake of an inconclusive study of the WHO claiming that this drug did not increase the chances of the users getting cancer. This move of the USFDA seemed to have stirred the Drugs Controller of India to give this injectable a license without proper trials. The ICMR, which had rejected Depo Provera in the seventies for its unacceptable side effects and insisted on in-country trials for almost every contraceptive, now advised the Drugs Controller to give the go-ahead. We protested again and Upjohn was asked to present documentation of research done in India. In response, Upjohn produced five disparate studies undertaken by stray researchers in the seventies. And it was these that formed the basis of approval for Depo Provera in India!

The opposition to Depo Provera was much more confrontative and we could prove what we knew all along. By insisting on dialogue and discussion we were able to easily establish that the licensing was improper. The campaign got tremendous media publicity. The attack against women’s organizations had no substance and primarily consisted of saying the obvious – we were non medical people, but no dents could be made in our argument. We decided to be more rigorous with campaigning among people and so far, this has discouraged large numbers of women from running to get this “miracle” injection.

Memorandum of women's organisations to the government (13/8/1993)

Women’s organizations have for a long time been voicing concern over the new trend of introducing hazardous, long-acting, provider-controlled hormonal methods of contraception. We have repeatedly approached the government for restraining them from the use of such contraceptives because:

1.In the name of giving women a better choice, they in fact take choice away from women and subject them to short-term side effects such as cardiac problems, hypertension, depression, clotting disorders and a number of long-term hazards as well.

2. These contraceptives require sophisticated procedures for screening and monitoring users, since contra-indications are numerous and include liver disease, diabetes, hypertension, suspected malignancy etc. among other conditions. Services to carry out screening and follow up do not exist in our country for the vast majority and existing services are being dismantled or privatized at a fast pace.

3. These contraceptives have a high potential for abuse because they can be administered without a woman’s consent and not removed either by the very design of the contraceptive (as in injectables) or by the choice of the medical practitioner (as in implants).

4. These contraceptives are being promoted in the name of reducing maternal mortality. However, with their life threatening side-effects and the inability of the health system to deal with the same, they are going to add tremendously to morbidity as well as mortality. Target orientation, social marketing and camp approach are in fact a pointer that the concern is more with meeting demographic objectives than with people’s health.

5. Not enough is known about the mechanism of these contraceptives which upset the entire bodily function by acting on the higher brain centres. Only one of the side effects is that of preventing contraception.

6. Under Indian conditions, lack of patient records and inaccessibility of the health system to the vast majority means that effective service delivery is also not possible, leading to high failure rates, which would mean pregnancies and birth of children with congenital malformations-thereby adding a new problem for the society.

7. The contraceptive needs of women differ, however, these contraceptives methods are catering to women who need continuous protection.

8. None of these methods contribute to the prevention of AIDS and STDs, which has to be an important criteria for new contraceptives, particularly when an epidemic is said to be imminent.

We have repeatedly asked for the promotion of barrier methods, and have enough data available at our disposal to show that these methods in conjunction with back up abortion services provide the safest contraception. We fail to understand why safe methods like the diaphragm despite being approved in India are not promoted. There is a similar disinterest in promoting vasectomy and male condom. We also fail to understand why women are targeted with a whole range of cafeteria, where each product is of dubious value, while new methods of vasectomy like no-scalpel vasectomy are limited to one or two premier institutions….

We were particularly alarmed when we were informed of the new plans to promote family welfare, at a meeting called by the Secretary, Family Welfare. We were informed that Depo Provera and Cyclofem are going to be introduced in the country without any trials. Net-En is also being introduced despite a court case against it pending in the Supreme Court….

Last year women’s groups had specifically raised an objection against the introduction of NORPLANT. This year ICMR has reversed its plans and is going to carry out a trial even though the sheer volume of biased promotional literature makes us believe that the decision to introduce this contraceptive has already been taken.

We Demand

*Drugs Controller be restrained from licensing untested contraceptives like Depo and Cyclofem.

*Net-En not be introduced until all questions raised in the Supreme Court are answered.

*Testing of NORPLANT be immediately stopped and existing biased literature be destroyed.

*No provider-controlled method, hormonal or immunological, be introduced within the country.

*Barrier methods be promoted.



Is pregnancy a disease that a vaccine is needed for its prevention? This is precisely the assumption that researchers have been working with. In India, a vaccine is under trial against hCG, the hormone needed to sustain a pregnancy prior to its implantation in the womb.

Women have been demanding safe and reliable means of contraception under their control. It is indeed unimaginable that any woman would want a contraceptive:

*About which neither she nor her doctor can tell with certainty when it is effective, without carrying out a blood test.

*Which has no definite period of effectiveness and is totally ineffective for 20% of the users.

*Which renders some of the users infertile for life

*Which cross-reacts and has the potential to destroy glands and disturb the hormonal cycle.

*Which can cause serious allergies and can exacerbate auto immune diseases like diabetes and rheumatism

*Which may become ineffective during any episode of illness or stress.

*Which influences the immune system of the body.

NO, THERE IS NO LOGIC FOR RESEARCH AND DEVELOPMENT OF SUCH CONTRACEPTIVES. Not only this, these vaccines will be given with Tetanus Toxoid or Diphtheria Toxoid and hence may affect the immunization programme adversely.

Anti-fertility vaccines (AFVs) are not really meant for contraception. Most contraceptives under trial today are rejected if they have more that 1-2% failure rate. Even the much maligned and now discarded rhythm method has a twenty percent failure rate and no side effects.

More than anything, AFVs are weapons of population control. The mathematics is simple. In the name of immunizing people, these vaccines can be administered to all women in an epidemic. Women do not even have to know that they are protected against pregnancy. So what if 20% women go ahead and have babies, the birth rate is cut instantaneously to 1/5th. Who cares about the adverse effects these may have for women or for that matter on their breast fed children (who get their immunity from their mother’s milk), or for that matter to children born as a consequence of contraceptive failure.

Available research suggests that these vaccines may make women prone to allergies, auto immune diseases and permanent sterility.

AVFs are being developed in many countries. It is a matter of shame that the Indian anti-hCG vaccine is furthest ahead in development and trials. This vaccine is so unsafe that it has not been registered in the US for research purposes.

Where do we go from here?

Time and again we have been accused of being anti-science for opposing research into and the introduction of new contraceptive methods. Therefore, it is imperative that we start defining what contraceptive research should be like. We met with women activists from thirteen other countries in 1995 and reaffirmed our commitment to this campaign and to call for a radical reorientation of contraceptive research – away from methods which have resulted in high levels of morbidity and mortality, especially in poor women. Therefore we resolve that:

1. Contraceptive research must focus on new methods which:

*Enhance women’s bodily integrity and physiological well being.

*Redress power imbalances between men and women, between providers and users.

*Address men’s unmet need for contraceptives.

2. Contraceptive research must weed out methods which do not conform to the criteria as in 1.

3. Contraceptive research should focus on the development of:

*low cost barrier methods

*methods which protect against sexually transmitted diseases

*post coital methods

*natural methods such as the lactational amenorrhoea method and ovulation prediction and on methods which revive long practiced traditional knowledge

*methods which address the consequences of non-consensual sexual intercourse, contraceptive failure and spontaneous unprotected intercourse.

4. Contraceptive research must investigate and bring to light the short and long term morbidity resulting from methods used in the service of population control for the last several decades.

5. Contraceptive research should be carried out only by such agencies which are:

*Committed to transparency of the entire research process.

*Fully accountable to the public

*Interdisciplinary in composition and include social scientists and ethicists

*Overseen by ethics committees comprised of a majority of women which adequate representation of potential users

We also insist that in every country where licensing of a particular contraceptive is sought, clinical trials must be carried out by groups independent of the developers and other stakeholders, and that every woman participating in the trials be guaranteed comprehensive health services and redress of any damages resulting from her participation in such trials. National agencies must be established to collect information regularly and systematically on the short and long term health status of contraceptive users.

Above all, clinical trials – regardless of where they are conducted – must conform to internationally accepted conventions of bio-medical research involving human subjects. We reject the concept of different standards for bio-medical research in different parts of the world.

In contraceptive research the welfare of individuals must take precedence over scientific goals. Population policies and profiteering have no place in contraceptive research.