Archive for Health

How ‘Per Vaginal Examination’ turned into the ‘two-finger test’

sterilization deaths

Indian laws, clearly stating the role of health professionals while carrying out examination of sexual violence survivors, do not make any reference to assessing virginity of the survivor, degree of habituation to sexual acts, status of the hymen and status of the vaginal elasticity. Despite this, and in the absence of standard medical protocols in such cases, Indian forensic medicine and medico legal bodies continue to refer to these aspects

By Sangeeta Rege

The issue of sexual violence requires a multi-disciplinary approach in order to provide comprehensive response to sexual violence. This multi-disciplinary approach requires several systems such as criminal justice system, health system, child welfare committees etc. to interact with each other. This short article focuses on the role of the health sector vis a vis sexual violence.

The Indian law has clearly laid down role for health professionals in responding to sexual violence. Sec 164A of CrPC lays down the components of medico legal examination namely seeking informed consent for carrying out examination and providing a logical medical opinion for results of the examination. It does not make any reference to assessing virginity of the survivor, degree of habituation to sexual acts, status of the hymen and status of the vaginal elasticity. Despite this fact medico legal examination continues to constantly make a reference to these aspects. These techniques have been devised and perpetuated in forensic medicine text books.

The problem is further compounded by the lack of standard protocol for medico legal care of survivors. Health professionals across the country continue to assess the hymenal status of survivors, determine laxity of vagina by carrying out a finger test, look for marks of resistance on her genitals or body, record physical attributes like built, height, weight etc.

To add to this confusion, the Delhi health department put out an advisory stating that finger test can be conducted in some instances such as to determine internal injures for rape survivors. The advisory confused the term “finger test” with the clinical examination term “ Per Vaginal (PV) Examination”.

Let us decode these confusions:

• Finger test – Finger test emerged from forensic medicine as a way of determining whether a person is habituated to sexual violence. It is done by inserting one or 2 fingers inside the vagina of a woman . If more than 1 finger passes without difficulty , the woman is said to be habituated to sexual activity . Such a test is unscientific and is rooted in biases and stereotypes about rape and misconceptions about virginity. Several High Courts and Supreme Courts have already called it an unscientific test and have asked health professionals to refrain from it. It also contravenes Section 146 of the Indian evidence act of 1872.

• Other unscientific tests – Just like the finger test, Forensic medicine has also developed methods of recording old tears to the hymen to state that the woman is habituated. They ask providers to measure height – weight to argue that if she is well built than the perpetrator, she could not have been over powered . These comments too are in complete contravention of the Section 146 of the Indian Evidence Act (IEA), 1872.

• Overemphasis on injuries – Forensic medicine in India further essentialises the presence of genital and physical injuries on the survivor . Absence of such injuries makes the doctors suspicious about whether the survivor is reporting the “ truth” or was it a consensual act . It is important to lay down facts about absence of injuries . Aspects like fear, threat to life, being too shocked / numbed by the attack , being rendered unconscious etc prevents the survivor from resisting the perpetrator.

However doctors do not take in to account circumstances in which sexual violence occurs and so are unable to understand the lack of injuries on bodies of survivor . Evidence from WHO multi country study 2003 also shows that only 1 in 3 survivors have chances of sustaining any injury . The changes in the law especially CLA 2013 in its explanation (2) to section 375 IPC has clarified that lack of injuries should not be understood as consent to the sexual act . However these changes have still not found its way in the medico legal practices across the country

• Overemphasis on presence of medico legal evidence – Medical professionals , police as well as the Judiciary believe that medico legal evidence is the most clinching form of evidence in the form of semen , blood traces , sperms , saliva , etc which will help in conviction of a perpetrator of sexual violence . In fact in a case of child sexual abuse , the judge allowed an acquittal for lack of medical evidence in the form of seminal stains , despite the fact that the 8 year old child had given the history of fingering in the vagina . This is the extent of how misplaced the understanding on medical evidence is even with the highest echelon in the justice system . What is gravely missed is that medico legal evidence rapidly erodes with time as well as activities such as washing , bathing , gargling, urinating etc . A survivor often needs time to come to terms with the assault , consult family members and reach a hospital or police station . So in many instances evidence of semen , blood etc is not found . But this is misinterpreted as sexual violence did not take place by doctors and thus they are unable to explain the lack of positive forensic medical evidence.

There is a need to correct the biases and prejudices related to understanding of medical evidence

• If a survivor has reported peno- vaginal assault or there are clinical signs / symptoms such as vaginal pain, bleeding , discharge etc. they indicate a need for internal examination only then a Per Vaginal Examination (which should not be confused with finger test ) is done . This is done with the purpose of identifying clinical causes underlying a specific medical condition. This examination requires fingers to be inserted in the vagina but to assess a clinical condition and is followed up with a treatment plan. Here too consent for Per Vaginal Examination should also be sought from the woman/ girl.

• Second, it is important to understand components of medical evidence. Medical evidence is:
 Trace evidence in the form of semen, spermatozoa, blood, hair, cells, dust, paint, grass, lubricant, fecal matter, bbody fluids, saliva.
 Injuries either on the body / genitals
 Presence of sexually transmitted infection that the perpetrator has passed to the survivor in the form of HIV, Hepatitis, Gonorrhea, and also unwanted pregnancy.
 It is important to understand that the possibility of finding forensic evidence decreases significantly after 96 hours after the incident. Even within these 96 hours after the incident, the extent of medical evidence found is subject to activities undertaken by the survivor in the form of bathing, urinating, gargling, defecating etc. Also possibility of finding semen evidence is based on whether perpetrator ejaculated or not. These activities should be recorded by the doctor and explained in the court when asked about lack of medical evidence .

 Most importantly the possibility of finding any forensic evidence depends on circumstances of the sexual violence and also nature of sexual violence , therefore the dependence on forensic evidence is misplaced

• Third, it is important to state that a health professional, in this case doctors, has dual responsibility – forensic and therapeutic. The therapeutic role though often ignored, has now been made mandatory by the changes in the law(Section 357C CrPC and Rule 5 of POCSO). No hospital and health provider private or public can refuse treatment to survivors of sexual violence. Refusal to provide treatment is now punishable by law (section 166 B IPC).

• Fourth, MOHFW (Ministry of Health and Family Welfare, Govt of India) in April 2014 recognizes dual role of doctors therapeutic and medico legal and provides specific directions to doctors for responding to not just women and children but also transgender and other marginalized communities. It also equips doctors to understand the scope of medical evidence and steps in interpreting medical evidence. Besides the state health departments, civil society organisations must also be informed about this practice and must push for a comprehensive health care response to survivors of sexual violence.

• MOHFW (Govt of India) established a multi disciplinary committee of experts and developed gender sensitive and uniform protocol for responding to sexual violence survivors. This is the first national directive by the Union health ministry in 2014 to all states to adopt such a protocol. These guidelines have been drafted under Sec 164A of CrPC and must be adhered to uniformly across the country.

This article is based on CEHAT’s collaborative program with the MCGM hospitals in Mumbai on implementing a comprehensive health care response

Govt shows interest in Depo Provera again

HPV-Vaccine

For the past three decades women’s groups in India have been fighting against the inclusion of Depo-Provera, the injectable contraceptive into the country’s family planning programme. With signs of a renewed interest from the government on the inclusion of this drug, it is imperative that activists discuss and articulate their views on this issue of grave importance to women and public health

By Sarojini N and Priya Ranjan

After the London Summit- FP2020, a renewed interest is being witnessed, amongst funders, foundations, NGOs, UN agencies and Ministry of Health and Family Welfare (MOHFW), in Depot medroxyprogesterone acetate (Depo), an injectable contraceptive.
Many international organizations/agencies/foundations are advocating that the Government of India introduce Depo-Provera (the brand name of DMPA) into the national family planning programme.

In fact, the Ministry of Health and Family Welfare (MOHFW) had recently recommended Depo’s inclusion in the Family Planning Programme (FPP) ostensibly to provide an alternative choice to women seeking to plan their families. However, the Drugs Technical Advisory Board (DTAB), the highest decision-making body on technical matters in MOHFW, has refused to give its nod on the recommendation of the department of family welfare for the introduction of Depo-Provera in FPP and has asked the Department to “examine the matter in consultation with the leading gynaecologists of the country for examining the effects of the use of the drug (Depo Provera) under National Family Planning Programme of the Government of India”.(Pharmabiz April 16, 2015).

There are a few NGOs and other international agencies who are working on issues related to Family planning, contraception and reproductive and maternal health that are in favor of Depo. They argue that injectables and implants provide better contraceptive options particularly for the poor and powerless women to exercise control over their own bodies and lives (since the contraceptive is injectable, neither husbands, nor in-laws would come to know of the contraceptive method used by women). Those who are in favor of injectables are also of the opinion that women should have freedom to choose the kind of contraceptives they want. They believe that the idea of offering injectables as a method of contraception is to widen the choices available to women and that the risk of morbidity and mortality associated with unwanted pregnancies must always be weighed against the side effects of contraceptive methods. There are also suggestions to introduce Depo initially at district level assuming it is equipped to ensure the screening and follow-up care for this method.

On the other hand, many women’s organizations and health groups have consistently opposed the introduction of injectables and implants for many years. Women’s groups have raised concerns regarding serious health risks and adverse effects of Depo on women along with the unequipped public health system to ensure the screening and follow up at all levels. Several studies have shown that the use of Depo leads to loss of bone density in young women. In fact, the US FDA in 2004 asked Pfizer to put black box warning on Depo’s label highlighting potential medical complication associated with the drug. The findings of more recent studies conducted in Africa demonstrated that the use of Depo-Provera may also increase the acquisition risk of HIV infection.

There are also other proven measures to reduce maternal (and infant) mortality besides preventing pregnancy.

Unfortunately, there has been hardly any discussion/debate on injectables and implants in recent years. It is important to speak to women who have used and are using Depo as a method of family planning. It is available in the private market and used extensively in regions such as Jharkhand. Data from this experience needs to be compiled and analysed. From anecdotal evidence it seems that the discontinuation rate appears to be high among the users of Depo. At the same time we should clearly articulate the other alternatives, as women do need safe contraceptive methods.

Given the fact that there is a renewed attempt to introduce it in FPP, it is imperative to discuss and articulate our views on this very important woman’s and public health issue.

History of Depo-Provera
Depo-Provera (Depo) is a synthetic hormonal drug with medroxy-progesterone acetate (MPA) manufactured by Upjohn Pharmaceuticals which was later acquired by Pfizer. In 1963, it was sold in the US as a treatment for incurable, inoperable cancer of the en-dometrium (lining of the uterus).

In 1967 Upjohn decided to sell DP as a long-term contraceptive and applied to FDA (Food and Drug Administration) authorities. As per news reports, two animal trials – mandatory for FDA approval—a seven-year long beagle dog trial and a ten-year long rhesus monkey trial began. DP was granted a conditional approval for use by those who could not use other methods of contraception.

In 1973 the FDA’s Advisory Committee on Obstetrics and Gynaecology recommended the Depo-Provera drug, DMPA, for use as a contraceptive.

In 1975 the FDA convened a joint meeting of its Advisory Committees on Obstetrics and Gynecology and on Biometric and Epidemiologic Methodology. The Committees in turn jointly constituted a sub-committee task force which, after open hearings, recommended that the FDA approve Depo as a contraceptive.

Following the implication of Depo in cervical cancer, the US Congress objected and in March 1978, the FDA stayed the issuing of the license to sell DP as a contraceptive in the US. By then Upjohn had already begun selling the drug especially in third world countries with a large amount of sales going to the International Planned Parenthood Federation (IPPF) which had begun distributing it in 12 countries, the World Health Organisation and the US Agency for International Development (AID).

The irony is that even before the US authority could register the drug, it was being used extensively in third world countries, or rather being ‘tested’ on large numbers of women

Following an appeal from the management, and a groundswell of opinion against the injectable contraceptive that in July 1979 the FDA appointed a Board of Inquiry. TheUS FDA was forced to hold a public enquiry, only the second time in its history, to decide on whether the drug should be licensed. Its verdict held that there was insufficient material to show that the drug was safe. This Board convened in January 1983 and a report was issued in 1984. The report stated that there was not enough evidence to prove that the drug was safe for women as a long term contraceptive.

The US FDA did not license Depo for use as a contraceptive until 1990. This was in the context of the resurgence of anxiety about the population explosion especially in the Third World and the fact that the latter had increasingly become cautious about licensing a drug which had not been registered in the country of origin.

Depo Provera had reached India in 1974 and the Indian Council of Medical Research trials had begun testing the contraceptive. However, the trials were soon cancelled apparently due to women dropping out of the trials and so there was no trial report put out. By 1984, the drug was said to be used in a few health projects, though as per news report in the EPW “several professionals and professional bodies have been, after a long silence on the subject, issuing statements urging the government to allow Depo in the Indian market.”

The early 1980s saw women and health groups in India taking a stand against contraceptives especially in the government family planning programmes. In late 1993, India decided to issue Upjohn with the license to market DP for contraceptive use which would be manufactured and sold by Max India. Depo-Provera was approved without the mandatory Phase 3 trials. It was to be sold on prescription, individually, not through the family planning programme. Its price was reportedly, Rs 120 per dose. The company issued a statement saying that they would be doing a Post Marketing Surveillance but they would be doing this on their own without the involvement of the ICMR or the Indian drug control authorities.

In 1993, women’s groups filed a case in the Supreme Court against the introduction of injectable contraceptives into the country’s family planning programme. The court ordered a stay on the drug’s use on the grounds that there was insufficient research on its suitability for Indian conditions.

In 2000, a study conducted by SAMA Resource Group for Women and Health (Unveiled reality: a study of women’s experiences with Depo-Provera, an injectable contraceptive. SAMA, Delhi, 2000) found that in Delhi at public health centers, women were being given injectable contraceptives without informed consent which meant they were not informed of the adverse side effects of the drug.

The potential of abuse, the incomplete mandatory trials and lack of control of government agencies over pharmaceutical agencies that sell the contraceptives were some of the grave concerns of the women, health, and human rights groups. Women’s groups again met with officials from the Health Ministry in 2000 to fight against the government’s intention to incorporate the drug into its family planning programme, though allegedly it had already begun doing so in Uttar Pradesh.

In 2005, a national workshop in October 2004 organised by Parivar Seva Sanstha along with the government of lndia, UNFPA and the Packard Foundation through the Population Foundation of India. The topic at hand was the introduction of injectable contraceptives. Following this a letter signed by 62 individuals and health organisation in India wrote a letter to the then Union Minister for Health and Family Welfare – A Ramadoss. An article based on the letter appeared in the Indian Journal of Medical Ethics written by N B Sarojini of SAMA and Laxmi Murthy of Saheli with title ‘Why Women Group’s Oppose Injectable Contraceptives.

The article stated that the relaxation of Indian drug regulations and the introduction of long-acting hormonal contraceptives such as injectables (Net En and Depo Provera) and sub-dermal implants (Norplant) would cause irreversible damage to the women and their progeny’s health.

According to the article, “administration requires ruling out contra-indications and close monitoring over long periods. Such monitoring is totally absent in this country. Poor women who visit government hospitals where injectables would be offered in the family planning programme would be treated as ‘living laboratories”.

The article pointed out that a five year post-marketing surveillance study was to have been done in place of the final stage of clinical trials. However, this report has not been made public. As per the article, several factors were revealed studying the post marketing surveillance study which had failed to address several serious concerns such as the potential side-effect of bone density loss and subsequent increased risk of osteoporosis, cancer risk, assessment of return of fertility, the effect of Depo on progeny conceived immediately after stopping the use of the drug, amenorrhea, irregular bleeding, generalised weakness and lethargy, migraine headaches, pain in the abdomen and severe abdominal cramps were relegated as “non-serious” medical events by researchers. The article stated that after scrutinisng many studies which favoured the use of DP, women’s groups have found no “scientific/medical justification for the introduction of injectable contraceptives like Depo-Provera or Net-En.”

The above information about the history of Depo Provera was aggregated by the FI Team from the following articles; Why women’s groups oppose injectable contraceptives by N B Sarojini, Laxmi Murthy

http://www.issuesinmedicalethics.org/index.php/ijme/article/view/702

‘Contraceptives: Case for Public Enquiry’, EPW, April 9, 1994
‘Retreat on Depo-Provera?’ by Padma Prakash, December 8, 1984

Supreme Court admits plea against cervical cancer vaccine trials

Supreme_Court_of_India

By Team FI

The supreme court of India on Monday has admitted a public interest writ petition against licensing and trials with cervical cancer vaccines in the country. The Court has asked the Government of India to file its reply in the matter immediately.

The petitioners -three health rights activists – argued that Gardasil and Cervarix are two unproven and hazardous human papillomavirus (HPV) vaccines purported to prevent cervical cancer, marketed in India by MSD Pharmaceuticals Pvt. Ltd. (subsidiary of Merck) and GlaxoSmithKline Ltd. The petition challenged their licensing for use in the private sector and attempts to introduce them in the public sector. The petition implicates the Drugs Controller for having licensed the vaccines without adequate research on safety and efficacy; the Health Ministry for not carrying out an enquiry into licensing of these vaccines as ordered by the Parliamentary Standing Committee on Health and Family Welfare in April 2010 nor taking any action on the report of the enquiry committee set up by itself despite all irregularities of PATH project being confirmed. Rather than looking at safety and efficacy of these vaccines in India, this project was meant to influence the government to adopt these vaccines for introduction in the public sector.

According to the press statement by the petitioners, PATH had initiated a project for the introduction of the two vaccines in India by signing an MoU with ICMR even before they were licensed by the Drugs Controller of India. This project was funded by Bill and Melinda Gates Foundation (BMGF) who had substantial stakes in Merck that produced the vaccine and hence there was a direct conflict of interest. PATH was helped by ICMR in carrying out large scale trials in the states of Andhra Pradesh and Gujarat unethically and without regard for health of poor tribal girls. The unethical nature of the study and deaths of girls became the subject of Governmental enquiry in 2010 when the matter was repeatedly raised by activists. This enquiry concluded that there were many gross violations in the project with respect to procedures for taking informed consent, inadequate health facilities for dealing with adverse events and medical emergencies. Yet after two years of the enquiry the government had not initiated any action to redress the situation and to punish PATH and ICMR as admitted by Ghulam Nabi Azad before the Indian Parliament in December 2011.

The petitioners have been raising the issue with the Health Ministry, the Drugs Controller, and National Commission for the Protection of Child Rights and other authorities including the government of Andhra Pradesh and have not made any headway. Hence a petition was filed under article 32 of the Constitution.

Hazards of the vaccines and unproven benefits
The vaccines are genetically engineered and their hazards are unknown even to the scientific communities. Though r-DNA has been detected in Gardasil in samples from many countries including India, in their application for licensing MSD pharmaceuticals claimed that there was no hazard because there was no r-DNA. GlaxoSmithKline uses a novel technique for producing Cervarix which involves the use of insect cells. Their product information admitted to their vaccine containing insect cells and proteins only in July 2011 though the vaccine was already in use since 2007. These residues or adventitious agents enter the blood stream when the vaccine is injected and are acknowledged to have the capacity to cause infections, tumours and cancer. What is noteworthy is that neither of these vaccines has been studied to determine their potential to cause cancer. In addition, the Drugs Controller has not even set standards of acceptable limits for such contamination in vaccines on the basis of which he could have found them safe for licensing.

Though both the vaccines are claimed to prevent cervical cancer, the truth is that cervical cancer takes twenty or more years to develop and the vaccines have just not been around that long to prove their efficacy in preventing cancer. But what is known with certainty is that if these vaccines are given to women who already are infected with the virus then they do raise the incidence of cervical cancer among those women.
Gardasil was first licensed in the USA in June 2006. This licensing was done on fast track with numerous conflicts of interests not only on the review board but also in that that the vaccine patent was held in PPP and the FDA itself as a part of the health department would benefit from the sales.

Licensing issues
Both vaccines were licensed for use among girls and women in India on the basis of very small studies that flouted even the liberalized Indian law. This law allows easy access to the Indian market for drugs and vaccines produced by multi-national companies once they are approved in the home country. In 2005 this law also made it possible for multi-national companies to hold trials for unapproved drugs in India simultaneous to international trials.

Targeting adolescents
These vaccines are supposed to work best when administered to girls in the age group of 9-14, before sexual debut. In the case of Cervarix GlaxoSmithKline did a trial with just 176 adult women and was granted a license for an age group of 10-45 year old women. This trial just looked at anti-body levels achieved and immediate side effects. No trial was done among Indian girls.

In the case of Gardasil, Merck through its subsidiary MSD signed an MOU with ICMR in 2005 but did not proceed with the studies that were envisaged involving thousands of women. But once it was licensed in the USA it did a speedy trial on its own with only 110 Indian girls 10-14 year old again to see immediate immune response. But it got a license by the DCGI to administer it to women from 9-26 years old though not a single adult woman had undergone a trial. According to the Indian law a trial on adults has to precede a trial among children and it was these violations that had been brought to the notice of the Parliamentary Committee that had asked for a proper enquiry into licensing.

Violations in PATH project
PATH on its own had decided to do studies with the HPV vaccine in four countries and India was one of them. The Indian market is substantial if a vaccine is accepted in the immunization programme. There is documentary evidence that though PATH is an NGO in this case it had entered into business agreement with Merck so that Merck had a ready market for the vaccine in the resource poor countries. In fact PATH got funding from BMGF in the very month that Gardasil was licensed in the USA. It signed an MOU with ICMR for this purpose. ICMR played along though it was clear that the vaccine was too expensive for India to afford. For each girl vaccinated the country would need to spend Rs 10,000 for three shots. The vaccines were marketed by hyping the risk of cervical cancer. Yet the fruits of this approach were not going to be reaped for 30-40 years or when the ten year olds crossed the age of forty – the age group when women are susceptible to cervical cancer. ICMR went ahead though it knew that the country is unable to meet the present needs of medicines to meet the current problems of the population like T.B. and malaria and could ill afford to spend money for these uncertain products. Further through its cancer registries it was also aware that the incidence of cervical cancer was declining and it was not a major health problem of the country.

PATH project was carried out in total disregard to scientific approach. It made false claims about the safety of vaccines and their efficacy. When the project took off there was no data to figure out the need for boosters, how the malnourished girls of India would respond to the vaccine that had so far only been administered to a healthy population. Yet a large number of girls in A.P. and Gujarat were administered a vaccine that had serious side effects including death. When four girls died in Andhra PradeshSupreme Court India women’s groups raised a hue and cry in 2010 and the government ordered an enquiry. The Government of AP, of Gujarat and PATH made depositions and provided data. The Enquiry Committee found that records of even informed consent had been fudged. The girls were not asked for their assent even though the law provides for such assent to be taken in writing. Further no arrangements were made for providing medical care to them if they suffered serious side effects.

Thus the rights of all 24,000 girls who were recruited by PATH in these trials were flouted as they were given the vaccine without a chance to make free informed choice. This assertion of women’s groups was confirmed by the enquiry. However, the Enquiry Committee had no legal expert and could not determine the liability of PATH towards the girls who were duped or forced into participation in PATH trial, those who died during the trial and those who would have suffered serious side effects.

PATH did everything to prevent the problems of the study from becoming common knowledge and sat on data on deaths despite women’s groups making a hue and cry about it at a public meeting organized by them in December 2009. The petitioners have pointed out that the data on death during the project is incomplete, illogical and full of discrepancies yet the deaths were called as being unrelated to vaccine administration. Side effects reported by the study were very rare and this was also brought out in the Enquiry. Yet there is no provision of continuing health care of these rural girls. Extrapolating from trial data of the two companies the petitioners have estimated that there are at least 1,200 girls in the two states have suffered from serious side effects or have developed auto-immune disorders who need continuing medical care and treatment.

These questions have been put before the Supreme Court with the hope that prompt justice and care would be provided to girls who are suffering as a consequence of an ill designed trial carried out by PATH with the active support of ICMR and the two state governments. By those very governments who are constitutionally bound to protect their life and health. Given the serious violations indulged by PATH, the petitioners have asked that PATH be blacklisted and no other foreign agency be allowed to have field presence.

The petitioners have also asked for the licences of the two products to be suspended and the vaccines recalled as there has been no scientific basis to allow their administration to girls in the private market either.

India revokes Roche pegasys patent

Roche Pegasys

The judgment is considered to be a major victory for health rights activists in India who have been fighting for affordable medicines

By Team FI

In a landmark judgment, the Intellectual Property Appellate Board (IPAB) has set aside the first ever product patent on a medicine granted in India to Roche for Pegasys, a medicine used to treat Hepatitis C.

The judgment was delivered by Justice Prabha Sridevan last week while hearing an appeal filed by a Mumbai-based non-profit organization, Sankalp Rehabilitation Trust.

In 2005, to comply with its international trade obligations, India re-introduced a system of granting product patents on medicines. In 1970, it had changed its patent law to disallow such patents precisely because they had resulted in high prices of medicines in India. This was the first product patent granted under the amended 2005 patent law.

The Indian patent law provides for several tiers of protection to ensure that only genuine inventions are protected by patents. For instance, it allows “any person” to file an opposition challenging its grant. This could prevent a patent from being wrongfully granted in the first place. If a patent is granted, it can still be challenged by a “person interested” in a post-grant opposition or in a revocation proceeding.

Sankalp had filed a post-grant opposition, which was rejected by the Patent Office. In the appeal filed by Sankalp before the IPAB, Roche sought to place a narrow interpretation on who a “person interested” could be. It argued that Sankalp is not a “person interested” because it was not a business competitor or a researcher. This issue probably arose for the first time before the IPAB. Rejecting Roche’s contentions, the IPAB held that a patients’ group that is a “person interested” in whether a patent is revoked or not.

Justice Sridevan noted that the revocation of a patent could bring down the costs of the medicine as well as increase supply. She also held that public interest is persistently present in intellectual property law.

On the merits, the IPAB revoked the patent on the ground that Roche’s claim of combining interferon (a protein known to treat Hepatitis C) with an inert PEG structure using conventional methods to obtain predictable results was obvious to a person skilled in the art. The IPAB also held that Roche failed to prove that the medication showed enhanced efficacy over other known pegylated interferons – a requirement under section 3(d) of India’s patent law.

According to Lawyers Collective, the group that represented Sankalp, the judgment now paves the way for Indian companies that may decide to launch biosimilars of the Pegasys medicine in India

Headquartered in Basel, Switzerland, Roche has been operating in India since 1993.

Featured Photo courtesy: Roche

Health Care: Technology on Trial?

Health care India

Opposing vaccine technology and clinical trials instead of ensuring efficacy and transparency in their process is like throwing the baby out with the bathwater

By Vineeta Bal

Vaccination is one of the pillars for cost effective preventive approaches for primary health care. Following the World Health Organisation (WHO) recommendation for expanded programme of immunisation of all children to reduce child mortality, in 1978, India introduced six childhood vaccines, Bacillus Calmette-Guerin (BCG), DPT (Diphtheria, Pertussis, and Tetanus), polio and typhoid. In 1985 under universal immunisation programme, the measles vaccine was added. Subsequently there have been further additions.

Though vaccination coverage in India is only around 40-50% in children by the age of one year, considering the geographical outreach of the programme, the number of vaccines administered and the number of beneficiaries, it is one of the largest in the world. Vaccination has significantly reduced the frequency of illnesses and deaths in children due Diphtheria, Pertussis, Tetanus, Mumps, Measles, Rubella, and other such diseases. Life expectancy at birth has shown tremendous improvement even though, of the 26 million children born in the country every year, approximately 1.83 million children die before they turn 5. What is disturbing is that a majority of these deaths could have easily been prevented with improvement in sanitation facilities, timely medical care and vaccination.

There is limited awareness about vaccinations in India and therefore there are many misconceptions. There are many, including some activists, who believe in ‘nature cure’ and ‘nature therapy’ indicating no active technological intervention. They protest strongly against the government policies for compulsory childhood vaccination.  Most of these demands are based on inadequate knowledge and have somewhat individual-centric perspective of human rights as explained later.

Interactions with activists from diverse backgrounds bring out one significant point – an apprehension about technology – because technology related discourse uses specialized jargon, a large section of activists do not follow it. There are also, the all-pervasive feudal relationships apparent even in such movements, which make grassroot activists accept what is told to them by leaders as good, bad or ugly without developing an adequate information base or an understanding of technology.

The cumulative data from years of vaccination experience, in millions of children in the developed countries, has helped us evolve a better understanding of the advantages and disadvantages of the process. Some rare serious adverse effects continue to affect recipients adversely. Some others like autism, which remained controversial for a long time, were recently proven as not linked to vaccination.

For preventing the occurrence of diseases in order to improve the quality of life of the people, the development of new vaccines and clinical trials to test their efficacy are essential steps. However, these vaccine development (or for that matter, drug development) projects often become works-in-progress with no guarantee of complete success.

The Human Papilloma Virus (HPV) based vaccines to prevent cervical cancer is a good example to discuss. Cervical cancer affects uterine cervix, the lower part of the uterus, which causes an estimated  2,75,000 deaths a year. Out of this approximately 70 per cent occur in the developing world. A study published by Lancet early this year, stated that in India itself, majority of the cancer deaths in women were due to cervical cancer and breast cancer.

The HPV vaccine was undergoing development from mid-80s. Large scale trials in various phases have taken place in the developed and developing world including India to evaluate the efficacy of the HPV vaccine. From 2008 onwards, the vaccines are commercially available and millions of women (and men for infection caused by the same virus) in the developed world have completed the primary schedule of the vaccination.

After the success of two HPV vaccines in clinical trials, with their impending availability in the market, PATH initiated a process for a post-licensure observational study in some countries including India in 2006. However, following enormous criticism and campaign from health activists, government stopped the PATH study in 2010. One cannot deny the fact that there were adverse effects observed during the trials including a few deaths. There were also many irregularities in the process – concerns over ethical issues and arbitrariness, flouting rules and regulations – that this did happen in connivance with government agencies made it worse. Besides, testing it on poor tribal girls was a problem, obtaining informed consent from teachers rather than parents was another flaw, not using well-defined feedback methods which include checking and reporting adverse effects was also a major concern. There were other sticky issues like introducing vaccine where no surveillance system for cancer screening exists on the ground.

However, the development of HPV vaccine, which may help to bring down the incidence of cervical cancer does not appear unjustified in itself. The vaccine is proven to protect from HPV infections (repeat HPV infections contribute to cervical cancer). In a span of 5-7 years, no one can ensure that incidence of cancer has gone down; it will take 20-30 years of follow-up. But the logic suggests that the vaccine would have its positive impact.

Thus, should this vaccine technology itself be the primary target for criticism or should the way in which it was used in India be looked at? Do health activists and feminists understand and make this distinction when opposing clinical trials?

If this distinction is not made, it would mean that these critics are working against efforts to develop a new vaccine or a new drug, rather than criticizing the way in which technological innovations are tested.

Perceived injustice and concern for the underprivileged define the basis for the civil society activism in one form or the other. While the individual pain and suffering of the underprivileged or the victims of injustice cannot be denied, that in itself cannot and should not form the basis of activism. When a broader philosophical view is taken, it seems that considerations for the ‘greater good’ of the society with a focus on social justice and equality, define the primary basis of the activism. At times, this may entail undermining individual human rights, as mentioned above.

With the passage of time, technologies are pervading our lives more integrally and comprehensively, hence taking an informed stand on developments seemingly linked with the use of technologies is vital for the ‘greater good’ of the society.

Vineeta Bal is a member of Saheli and a scientist at the National Institute of Immunology, Delhi. The views expressed here are personal.

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