Patient and leading health organisations in South Africa have now joined a Fix the Patent Laws campaign launched in 2011 by Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) to push for reform of the country’s current patent laws.

The campaign’s promoters say that these laws severely restrict access to affordable medicines for all people living in South Africa.

The organisations which have adhered to the campaign are: People Living With Cancer (PLWC), South African Depression and Anxiety Group (SADAG), DiabetesSA, CanSurvive, SA Federation for Mental Health (SAFMH), Stop Stock Outs, Cancer Association of Southern Africa (CANSA), Schizophrenia and Bipolar Disorder Alliance (SABDA), South African Non-Communicable Diseases Alliance (SANCD Alliance), Marie Stopes, Epilepsy South Africa and Cape Mental Health.

Together, they are calling on the South African government to finalise a National Policy on Intellectual Property that champions measures to reduce prices and increase access to a wide range of medicines for people in need across the country.

TAC and MSF reported Jun. 1 that the expanded coalition of organisations represents public and private sector patients in South Africa seeking treatment and care for a range of cancers, mental illnesses, diabetes and other non-communicable diseases – as well as tuberculosis, HIV and sexual and reproductive health diseases.

South Africa currently grants patents on almost every patent application it receives, allowing companies to maintain lengthy monopoly periods on medicines, argues the campaign. This keeps prices of many medicines higher in South Africa than in many other countries.

According to TAC and MSF, it is estimated that 80 percent of patents granted in South Africa do not meet the country’s patentability criteria. This is largely due to the fact that patents are granted without substantive examination of applications to ensure that patentability criteria are met.

“Some cancer patients would rather go to other countries, like India, for treatment – the combined cost of the flight, medical services and drugs is cheaper than buying the drugs alone in South Africa,” said Bernice Lass of cancer group, CanSurvive.

Linda Greeff of PLWC said that her organisation was supporting the campaign because “we want to ensure that there is proper scrutiny of patent applications before patents are granted. We want a patent granting process that is ethical and transparent, so that more people can access the medicines that they need.”

According to Cassey Chambers of SADAG, the group deals with “patients every day who cannot afford medication or treatment, and as a result become more depressed, helpless, hopeless and even suicidal in some cases.”

DiabetesSA’s Keegan Hall stressed that as health organisations, “we have an obligation to take steps to improve affordability and access to medicines. The cost of insulin and other diabetes management tools are far too expensive for many patients,” Hall added.

Health organisations joining the Fix the Patent Laws campaign say that they recognise the opportunity South Africa has to improve access to medicines for all diseases through reforming problematic patent laws.

South Africa’s Department of Trade and Industry (DTI) has already embarked on the process of legislative reform, releasing a Draft National Policy on Intellectual Property for public comment in 2013. The draft policy contained important commitments to reform the laws in order to restore the balance between public and private interest, in favour of people’s health.

The Fix the Patent Laws campaign coalition is calling for urgent approval of a finalised National Policy on Intellectual Property, as a critical first step toward reform of problematic patent laws and practices that deprive people living in South Africa of more affordable treatments for all conditions.

It notes that as a member of the World Trade Organisation (WTO), South Africa is required to uphold minimum standards of intellectual property protection as defined by the international Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). This includes granting 20-year patents on medicines.

However, South Africa also has significant flexibility under TRIPS to amend national legislation in order to improve access to medicines. According to the health organisations, reforms could include the government taking measures to limit abusive patents being granted on medicines.

At the same time, it says, government could establish easier procedures for overcoming legitimate patent barriers when medicines are unaffordable, unavailable or not adapted for patient needs.

Edited by Phil Harris   

By Martin Khor
GENEVA, Mar 9 2014 (IPS)

If you or some family members or friends suffer from cancer, hepatitis, AIDS, asthma or other serious ailments, it’s worth your while to follow the negotiations on the Trans Pacific Partnership Agreement and other similar bilateral trade agreements.

It’s really a matter of life and death. For the TPPA can cut off the potential supply of cheaper generic medicines that can save lives, especially when the original branded products are priced so sky-high that very few can afford them.

Recently, a cancer specialist in New Zealand (one of the TPPA counties) warned that the TPPA would prolong the high cost of treating breast cancer because of new rules to protect biotechnology-based cancer drugs from competition from generics. And this will affect the lives of cancer patients.

Some cancer medicines can cost a patient over 100,000 dollars for a year’s treatment. But generic versions could be produced for a fraction, making it possible for patients to hope for a cure and a reprieve from death.

In India, local companies are leading the fight to make medicines more affordable to thousands of patients suffering from breast, kidney, liver and

gastrointestinal cancer and chronic leukemia.

For example, an Indian company produced a generic drug for kidney and liver cancer 30 times cheaper than the branded product (140 dollars versus 4,580 dollars for a month’s treatment) after it was given a compulsory license.

India has a law that disallows patents for a newer form of drugs or known substances unless it improves the medicine’s efficacy or effectiveness. Under the World Trade Organisation (WTO) rules, countries are free to set their own standards for novelty, or whether a product is novel enough to be eligible for a patent.

Also, in many countries, the patent law allows for companies to obtain compulsory licenses to import or make generic versions of original medicines. Governments grant such licenses if the branded products are too expensive and the original companies do not offer attractive terms for a voluntary license to other firms.

Multinational companies have strongly opposed compulsory licenses or the Indian-type laws that allow for patents only for genuine innovations.

This is where the TPPA comes in. Mainly at the insistence of the United States, countries are being asked to accept standards of intellectual property, that go beyond the rules of the WTO’s.

Especially noteworthy is the U.S. insistence that the TPPA countries agree to give a type of intellectual property known as “data exclusivity” for five years to companies producing original medicines.

This is extended to eight or 12 years for “biologics”, or medicines made with biotechnology. Many of the new medicines for treating cancers are biologics.

This will cause immense problems for patients waiting for cheaper medicines because “data exclusivity” prevents generic companies from relying on the safety and clinical trial data of the original company to get safety clearance for their generic products.

Thus, even if a generic company can prove that its medicine is bio-equivalent to the original medicine that has already passed the safety standard required by the health regulatory authorities, it will not be allowed to sell its medicine unless it comes up with its own safety and clinical trial data.

This goes against the current practice of generic medicines and safety standards. But the U.S. is insisting on this in the TPPA.

Few generic companies have the funds or technical ability to do their own clinical trials, and thus generic medicines could well be prevented from being used in TPPA countries for five to 12 years – even if the medicines are not patented.

That is the most significant aspect of the TPPA, and this is why so many groups of patients, health organisations and independent medical experts have been outraged and outspoken in their opposition to the agreement.

According to Jamie Love of Knowledge Ecology International, an expert on drugs and patents, the average cost of eight biologic cancer drugs registered with the U.S. drug authorities in 2011-2013 is 128,000 dollars (for a year’s treatment), with the most expensive being over 390,000 dollars. At such prices, hardly anyone in developing countries can afford these medicines.

In mid-February, eight prominent organisations including Medicins Sans Frontieres, Oxfam, Public Citizen, Health Gap and Knowledge Ecology International, issued a strong statement on their deep concern about the public health implications that the TPPA’s measures will have for millions of patients in need of access to affordable medicines around the whole Asia-Pacific region.

Said the groups: “The negotiations must take into account the health needs of all patients living in TPPA countries, and the U.S. must halt its efforts to limit countries’ freedom and flexibilities, otherwise the TPPA will jeopardize many, if not millions, of lives.”

Developments in India, which is not a TPPA country, show the patient-friendly policies that can emerge when public health concerns are given priority.

For instance, an Indian company is producing a generic version of the drug Gleevac, which is used to treat a chronic form of leukemia as well as gastrointestinal cancer, bringing the cost of treatment down from 70,000 dollars a year (in the U.S.) to 2,500 dollars a year in India.

This was possible because the Indian government denied the original company a patent on Gleevac because it was not judged to be novel enough, and an objection to that decision was rejected by the Indian Supreme Court.

Countries that join the TPPA will find it very difficult or impossible to undertake policies and practices similar to India’s, should the U.S. proposals in the intellectual property chapter be accepted.

Moreover, countries that don’t produce the generic drugs have the option to import them from India and other generics-producing countries. But if the TPPA imposes data exclusivity rules of the type desired by the U.S., it would be difficult to import and sell them.

Some countries are opposed to some of the U.S. proposals. The views and positions that defend public health must prevail, for after all, it is a matter of life and death.

Excerpt:

Despite hurdles in trade, Indian medicines find their way usefully into Pakistan. Credit: Ashfaq Yusufzai/IPS.

By Ashfaq Yusufzai
PESHAWAR, Pakistan, Feb 26 2014 (IPS)

They are contraband, yet a large number of Pakistanis have come to depend on drugs made in India and smuggled into Pakistan. Patients as well as doctors say these are cheap and effective, even as law enforcers look the other way.

The two countries do not have a trade agreement on drugs, but markets in Khyber Pakhtunkhwa province in the north of Pakistan do brisk business in India-made medicines that are sold over the counter.“We are aware of huge stocks of medicine being smuggled into Pakistan from Afghanistan but we don’t take action because we know these benefit the local population." -- drug inspector Muhammad Riaz

“I have been prescribing India-made medicines to patients for a long time because of their effectiveness,” Dr Abdul Kabir, a medical practitioner based on the outskirts of Peshawar, tells IPS.

Doctors in rural areas prescribe them to people who cannot afford the pharmaceutical products of western multinational companies or do not find local brands effective.

For instance, famotidine, a locally made drug used for stomach-related illnesses, is available for 200 to 500 Pakistani rupees (1.90 to 4.70 dollars) while the same preparation from India is sold at 30 to 50 rupees (30 to 45 cents).

Most of the 60,000 chemists in Khyber Pakhtunkhwa and the Federally Administered Tribal Areas (FATA) rake in a good income from the sale of Indian drugs.

“Pharmaceutical items smuggled in from India are available over the counter and officials concerned also know that these are effective,” Mushtaq Ali, a Peshawar-based chemist, tells IPS.

Ali says Indian medicines such as antibiotics, painkillers, anti-cancer injections, tranquillisers and anti-hypertensive drugs are easily available and have plenty of buyers. Among these are paracetamol, diclofenac, misoprostol, amoxicillin and ampicillin.

“Most chronically ill patients prefer Indian drugs because they require medication for longer periods. Local medicines are extremely expensive compared to Indian ones, so people opt for the latter.”

Patients in Khyber Pakhtunkhwa and FATA are the biggest beneficiaries of Indian drugs. That is because Afghanistan purchases drugs from India under a trade agreement and from there the medicines are smuggled to these two areas that border the neighbouring country.

“We are aware of huge stocks of medicine being smuggled into Pakistan from Afghanistan but we don’t take action because we know these benefit the local population,” drug inspector Muhammad Riaz tells IPS.

There are around 200 MNCs and 300 local pharmaceutical companies that sell drugs in Pakistan but their products are expensive, he says. The MNCs import raw material from their parent countries.

On the other hand, low-priced drugs marketed by local companies are often not effective, and are not always prescribed by doctors, Riaz says.

He says Pakistan’s Federal Quality Control Board has often tested Indian medicines and found them to be highly effective. “So stopping the sale of smuggled Indian drugs would amount to denying treatment to impoverished people.”

Jaffar Shah, a resident of Mardan district in Khyber Pakhtunkhwa says, “My father has been using medicines for high blood pressure for 10 years. Initially we used drugs marketed by MNCs, but then we ran out of money and resorted to an India drug which is far cheaper as well as effective.

“There are many people in our neighbourhood who use Indian drugs and are satisfied with their quality,” says Shah. “A neighbour of mine who suffers from cancer is taking Indian drugs as advised by his doctor because they are affordable.”

Indian medicines are also favoured for use for HIV/AIDS patients.

“Pakistan doesn’t have any trade agreement with India for medicines. The World Health Organisation has been importing anti-retroviral drugs from India for HIV/AIDS patients in Pakistan and these are provided at 13 centres across the country,” says Dr Atif Khan of the Hayatabad Medical Complex in Peshawar, capital of the Khyber Pakhtunkhwa province.

“These drugs are 20 times cheaper than those supplied by MNCs. They are being imported from India since 2005. These drugs are, however, only provided in hospitals under the supervision of qualified doctors,” he says.

The issue of smuggled Indian drugs has often come up in Pakistan’s National Assembly but the matter has been hushed up every time because lawmakers don’t want to invite public wrath by banning them, Khan says.

According to Rasool Shah, a senior teacher in the pharmacy department at the University of Peshawar, India had long allowed its manufacturers to get international patents for their products due to which its generic drug industry has flourished.

“Indian drug manufacturers try their best to get a slice of the 200 billion dollar market in Pakistan. MNCs based in the country are concerned because they are rapidly losing the market to Indian drugs.”

The Supreme Court has extended its ban on clinical trial of 162 new drugs till Dec. 16, 2013. Credit: epSos.de/ CC BY 2.0

By Ranjita Biswas
KOLKATA, Nov 5 2013 (IPS)

More than 2,500 Indians have died in the course of clinical trials in recent years, government figures reveal.

According to an affidavit filed by the health ministry in the Supreme Court in response to a petition by health NGOs, there were 80 deaths due to clinical trials between January 2005 and June 2012. Between July 2012-August 2013 nine more such reported deaths occurred, making this total 89, according to the petitioner Swasthya Adhikar Manch (SAM), a health rights forum. Compensation was paid in 82 cases.

The ministry also admitted that 2,644 people died during clinical trials of 475 new drugs from 2005 to 2012.

SAM challenges this number of 80 deaths said to have been caused by clinical trials – among the rest who are said only to have died during the course of the trials and not as a result of the trials.

“No standard protocol was followed, there were no post-mortems; so how can they arrive at this figure?” Amulya Nidhi of SAM told IPS. Compensation is paid only if a death was said to have been caused by the clinical trial.India has become a hub of clinical trials for drugs over the last few years, mostly by pharmaceutical companies from abroad. Allegations of short-changing participants and of unethical practices have been rampant.

Government documents also say that around 11,972 “serious adverse events” (excluding death) were reported from Jan. 1, 2005 to Jun. 30, 2012, of which 506 were said to have been caused by clinical trials.

These figures have raised new opposition to the prevailing practices for conducting clinical trials.

India has become a hub of clinical trials for drugs over the last few years, mostly by pharmaceutical companies from abroad. Allegations of short-changing participants and of unethical practices have been rampant.

Responding to growing concerns by health activists, the ministry of health and family welfare set up a six-member expert panel under the Central Drugs Standard Control Organisation (CIDSCO) in February this year. The panel has recommended that these trials should only be carried out in accredited centres.

It recommended also that the principal investigator and the ethics committee of the institute where the trial is being carried out should be accredited.

Compensation is another contentious issue that is being dealt with in the new directive. Between 2010-2012, the Drugs Controller General had approved 1,065 clinical trials. Activists say that taking advantage of poverty, illiteracy and lack of awareness, pharmaceutical companies or middlemen, even doctors, often connive to deny compensation to participants when due.

The report clarifies: “Compensation need not be paid for injury or death due to totally proven unrelated causes. In all other cases of death or injury/disability, compensation should be paid to the participant or his legal heirs.” The base amount and other calculations are still being worked out.

“The report deals with the issues we raised,” Chinmoy Mishra, coordinator of SAM, told IPS. “Now we must see these recommendations are properly implemented.”

Public health is in the hands of state governments in India’s federal system. The panel report noted that for implementation all stakeholders must be brought to the table.

SAM, based in Indore in Madhya Pradesh state, is a platform of various agencies working on issues related to health and health rights. It had filed a petition in court in January 2012 on the need for transparency in clinical trials in India.

The Economic Offence Wing of the state government had recorded 36 deaths between 2006-2010 during clinical trials in Madhya Pradesh state alone, SAM noted.

The National Human Rights Commission has pointed out that illegal trials were conducted on women in 2011 for a breast cancer drug.

In 2006, an investigation by health advocacy organisation WEMOS and the research organisation Centre for Research on Multinational Corporations (SOMO), both based in Amsterdam, prepared  an overview of 22 unethical clinical trials around the world; eight of them were in India.

According to the health ministry, more than half the clinical trials are conducted by foreign pharmaceutical companies and the rest by clinical research organisations and domestic companies.

SAM is petitioning for equal compensation across the board throughout the whole country, and according to international standards.

“Informed consent from each participant is a mandatory prerequisite for a clinical trial,” the CIDSCO report emphasises. This is an area that unethical practitioners have been taking advantage of, Mishra said.

“For example, the 16-page directive on this count is translated into local Hindi language that fits into a single page, and that too improperly translated. In Indore, at least 95 percent of participants did not know what it was all about and signed.”

On the other hand, lack of regulation has driven away some pharmaceutical companies from India to other countries such as Malaysia, China and Singapore. Many also hope that the new norms will bring these companies back, because this is a multi-billion dollar industry.

To reduce bureaucratic tangles, the present 12 drug advisory committees will be replaced by a single technical review committee for speedy clearance of applications.

The panel has said that the first phases of all clinical trials of new drugs developed in India, and to be marketed in India, will need to be carried out within India. Drugs undergoing trials outside India can undergo parallel phase II and phase III trials in India after carrying out a safety assessment through phase I trials.

Demands have been raised for greater benefits to those undergoing trials. “Some of the drugs that are clinically tested in India could be so expensive that the average person would not be able to afford it,” Sandhya Srinivasan , health journalist and researcher in Mumbai, told IPS. “So what’s the use of such tests in this country?”

Mishra said that “we are not against clinical trials in the country. But there should not be exploitation of participants. Human life is precious.”

According to documents submitted by the Drugs Controller General of India in the Supreme Court, between January 2005 and June 2012 India approved 475 clinical trials for “new chemical entities” not used as drugs elsewhere in the world.

Meanwhile, the Supreme Court has extended its ban on clinical trials of 162 new drugs till Dec. 16, 2013, directing the government to ensure a “foolproof” mechanism for regulating the experiments by pharmaceutical companies.