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Current Events 21 March 2016



21 MARCH 2016


Standing up to patent bullying

Earlier this month, the media reported that India “privately” assured the United States that it will not issue any more compulsory licenses. This report was reminiscent of a theory propounded by psychologist Lenore E. Walker in 1979 on abusive patterns in relationships.

Four stages of abuse

Walker studied abuse in family situations and outlined an important model detailing four stages of abuse. Had the U.S. and India been human beings, this would have been a classic case of household abuse. The first stage documented by Dr. Walker is tension-building where there is strain in the relationship and one partner tries to dominate the situation. Indeed, the U.S. has successfully dominated the discussions simply by citing India every single year, most often unfairly, to take control of the situation. For years, the Pharmaceutical Research and Manufacturers of America (PhRMA) has pounded India using the Office of the United States Trade Representative (USTR), an administrative body, as its chosen mechanism to repeatedly criticise India and unfairly escalate issues on a yearly basis. The preaching from the PhRMA filtered through the USTR’s pressure tactic has been in complete disregard of the impact on India’s sovereignty and public health. The issuance of notices by USTR for submissions by industry followed by the dramatisation to convene public hearings expecting sovereign nations to justify their positions to the U.S. administrative body are all acts leading towards escalation of tensions. In fact, the USTR process is a documented attempt to dominate and direct other countries’ trade postures. The process allows the U.S. to unilaterally exert pressure indirectly to amend laws or cease fair implementation of local laws although the U.S. has agreed to multilaterally resolve all disputes. Importantly, the legality of such unilateral Special 301 process of the USTR is, at best, shaky under the World Trade Organisation’s (WTO) jurisprudence. Yet, it allows the U.S. to cite the USTR’s Special 301 process to take control of the dialogue — this forms Dr. Walker’s second stage of the abusive cycle (the incident itself).

The announcement from India, though, landed the country into the third stage. Dr. Walker terms this as the honeymoon stage wherein the abused feels confused and may mistakenly feel responsible. India is in classic third stage, with Prime Minister Narendra Modi attempting to pacify President Barack Obama by instituting a committee to create a National Intellectual Property Rights policy long after the statutes were amended to become compliant with the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Now, the “private” announcement to not implement an important flexibility — compulsory license — established as a safeguard to protect public health firmly posits India into the end of the third stage of abuse. The fourth stage, according to Dr. Walker, is a phase of relative calm and peace, which we hope India will enjoy.

Compulsory license

Meanwhile, the Modi government needs to appreciate that compulsory license is an important flexibility that countries negotiated as part of their membership with the WTO. India has one of the most sophisticated compulsory licensing provisions which is fully compliant with the TRIPS agreement. Under the Indian law, compulsory licenses can be granted on several grounds including satisfying the reasonable requirements of the public with respect to the patented invention, ensuring availability to the public at reasonable price, meeting the demand for the patented product, and tackling national public health emergencies. The step India took when it compulsorily licensed the Bayer drug, Nexavar, which was originally priced approximately at $4,700 per month and beyond the reach of even the top 20 per cent of Indians, was bold. It showcased India’s confidence that its patent statute has been carefully engineered to accommodate India’s national objectives within the scope of the flexibilities accorded under the TRIPS agreement.

Patenting, a concern in the U.S.

Further, the Modi government will do well to appreciate that even in the U.S., patenting and its effect on unrealistic drug pricing has become a major concern. For example, in 2015, Senate Finance Committee Ranking Member Ron Wyden and senior committee member Chuck Grassley sought public comments on the high price of Sovaldi, a Gilead drug, and its impact on the U.S. health care system. In 2016, several Democratic members of the House reportedly urged government agencies to consider diluting or diminishing the exclusive rights of drug companies. Recently, a survey from the Kaiser Family Foundation reported that 77 per cent of the American public picked the increasing prices of drugs for HIV, hepatitis, mental illness and cancer as their foremost health concern. Given such realities, India needs to confidently showcase how it handled Bayer’s unrealistically high pricing of Nexavar using Section 84 of the patent statute (compulsory licenses).

Importantly, compulsory licensing forms a part of a larger package of flexibilities that India negotiated with the support of other G-77 and African countries in the Doha Development Round. These are valuable concessions that India cannot afford to forget or renege from. The burden is on this government to ensure that its work is not seen as resulting in losing the ground that previous governments had gained on the subject. In any event, it is best for the Modi government to stop engaging U.S. bureaucrats as patent consultants and instead showcase the Indian patent statute as an exemplar for a balanced patent regime to the rest of the developing world.

Rawat gets nine days to prove strength

The political crisis in Uttarakhand continued over the weekend, as Governor K.K. Paul gave Chief Minister Harish Rawat of the Congress a deadline of March 28 to prove his majority in Assembly.

Mr. Rawat met the Governor after 10 Congress MLAs turned rebel. Mr. Rawat maintained that he still enjoyed a majority in the 71-seat Assembly (with one nominated member), even as Speaker Govind Singh Kunjwal, in his report to the Governor, said the Finance Bill, being considered for passage, was passed through a voice vote.

The Speaker’s report also says the demand for division was made after the House was adjourned. A video-recording of the proceedings was also handed over to the Governor. The Opposition BJP and the rebel MLAs are claiming that the Bill, a money bill, was defeated through a voice vote as at least 10 Congress MLAs had cross-voted and called ‘nay.’

The era of plastic-degrading bacteria has begun

It is hardly a hundred years since chemists learnt to make long molecules called polymers and plastics in the lab. Polymers have since been hailed on one hand as the greatest boon to mankind for their manifold uses, and the greatest bane - thanks to the way that they have cluttered the environment. The most common synthetic polymer or plastic used in everyday life is polyethylene terephthalate or PET (also known as Terylene or Dacron). An estimated 311 million tonnes of plastics are produced every year (and 50 million tons of PET alone). Unfortunately many of them, such as PET, are not degraded, digested or broken down like naturally occurring polymers (such as proteins, carbohydrates and fats). We use plastic in everyday life, use and discard them, hardly recycling them (to the extent we actually can), and as a result plastics have cluttered the earth and its oceans. J.R. Jambeck and others have estimated that as much as 5 trillion pieces of plastic have reached and are found in ocean beds across the globe That is anywhere between 5 to 13 million tonnes of them, lying and affecting the health of ocean life (and an area of about 1.4 million square kilometers, or the area of Northern India). There is no clear estimate of how much plastic is fouling the land mass of the earth, surely it has to be an equal amount.

If only we can find ways to degrade such huge amounts of accumulated plastics! And the best agents to do so would be biological life forms such as bacteria which multiply by the millions in days and are themselves completely biodegradable. (Indeed, recall how, way back in 1980, Dr Anand Chakraborty of GE R&D Center at Schenectady, NY, isolated one such microbe that would eat off oil spills). It is towards this challenge that research has been going on, and the latest effort which shows some success has been published in the March 11, 2016 issue of Science by a Japanese group, led by Dr Kanji Miyamoto of Keio University, Kanagawa. The group concentrated on looking for and identifying bacteria from the PET bottle recycling sites, and found one such microbe that they have named Ideonella sakaiensis (the first name identifies the family and the second honours the geographic location where they found the bacterium).

I. sakaiensis sticks to the surface of the PET bottle, secretes one molecule named which they named PET-ase (the suffix “– ase” denotes an enzyme molecule), which breaks down PET into a smaller building block abbreviated as MHET. MHET is now taken up and broken down by another enzyme in the microbe’s cell (called MHET hydrolase) and hydrolysed to produce ethylene glycol and terephthalic acid - the two small molecules (called monomers) using which the polymer PET is made in the first place. We should admire I sakaiensis for its efficiency as a safe biodegradable agent. Biologists will now wonder about how this microbe, which all these centuries and millennia had never known PET (until 70 years ago) has suddenly found (or generated) enzymes to degrade this new man-made polymer. Myriad and wonderful are the ways of mutations and natural selection.

Two interesting points emerge from the Japanese work. One is: can we now isolate the ethylene glycol and terephthalic acid, the two monomers, and reuse them to make PET? This offers a nice self-contained set up where the PET bottles and plastics discarded after use are biodegraded back to the starting materials in a bio-reactor, and then taken to the polymer synthesising unit which remakes the PET.

The other point is more challenging and surely there are molecular biologists already working on it. That is: why not clone the genes that express the enzyme PET-ase and MHET hydrolase into some other properly chosen microbe (other than I.sakaiensis), using genetic engineering methods and thus attempt to biodegrade the vast mountains of PET fouling the earth? If one can do this for PET, surely it can be done for other polymers and plastics.

Even more changeling is the issue of how to clear the millions of tons of plastics fouling the oceans beds. Even if bugs are founds that can biodegrade them, will they be safe for the oceans and their life forms? But this needs to be done and as they say “nothing ventured nothing gained”. It can perhaps first be done in silico using the methods of computational and system biology, to look for optimal ways to do so and then try on a lab scale. Clearly the Kanagawa group has kindled an exciting chapter in environment sciences with their work.

More power to the vaccine arsenal

India has made huge strides as far as public health achievements are concerned, made possible by the use of safe and effective vaccines delivered through quality programmes. For example, small pox was eliminated in 1975, polio in 2014 and maternal and neonatal tetanus (MNT) in August 2015.

While India has shown its ability to undertake massive campaigns to improve vaccination coverage, routine immunisation coverage, which stands at 65 per cent when last measured, remains low. Moreover, the immunisation schedule lacks important vaccines that are already in use in most countries. All that is set to change.

In 2014, the Prime Minister’s Office announced the decision to introduce four new vaccines as part of India’s Universal Immunization Programme (UIP). These are vaccines against rotavirus, rubella and polio (injectable) and an adult vaccine against Japanese encephalitis introduced in districts with high levels of the disease. Earlier in 2011, a vaccine against Haemophilus influenza type B (Hib) was introduced as part of the pentavalent vaccine to contain diphtheria, pertussis, tetanus, hepatitis B and Hib. Thus the government has introduced or committed to introduce more vaccines than it has in the last 30 years of the UIP.

These vaccines could collectively prevent at least one lakh infant deaths, deaths of adults in the working age group and up to 10 lakh cases of hospitalisation each year. India’s UIP will now be able to provide free vaccines against 13 life-threatening diseases to 27 million children annually, the largest birth cohort in the world.

The India Newborn Action Plan (INAP) was launched in September 2014 with the aim of reducing preventable newborn deaths and stillbirths and the goal to attain single digit neonatal mortality and stillbirth rate by 2030. The current rate is 38/1,000 live births. To reach this goal, four additional vaccines are being thought of as priority vaccines for introduction in India.

Priority vaccines

The first of them is the Pneumococcal conjugate vaccine. Singularly, bacterial pneumonias kill more children under the age of five than any other disease. India has the world’s highest number of deaths caused by Streptococcus pneumoniae, the bacteria most commonly associated with pneumonias. There are an estimated 5-6 lakh cases of severe episodes of pneumococcal pneumonia and 95,000-1,05,000 deaths in India annually. An effective and safe vaccine for pneumococcus pneumonia is available.

The Human Papillomavirus (HPV) vaccine is next. Cervical cancer is one of the top three cancers affecting women in the world. Worldwide, every fourth new case is an Indian. It is estimated that in India, there are 1.32 lakh new cases every year and about 75,000 deaths reported. Two strains of HPV-16 and -18 are responsible for almost 80 to 85 per cent of cervical cancers. Preventive vaccines are available and are given to adolescents (9-13 years).

The third is the influenza vaccine. Immunising mothers during pregnancy against vaccine-preventable diseases has the potential to improve health outcomes in mothers and their children. This is likely to emerge as a key strategy to address neonatal mortality in particular which accounts for almost half of the under-five mortality. This strategy has been successfully used to eliminate MNT. Clinical trials have shown that influenza vaccination during pregnancy can prevent influenza disease in pregnant women and their newborn children for the first six months of life with no indication of harm to the recipients or their children .

Given the potential impact of maternal influenza immunisation programmes on maternal and child health worldwide, the World Health Organisation Strategic Advisory Group of Experts on Immunization (SAGE) has recommended that pregnant women having influenza vaccine receipt in countries initiating or expanding their influenza vaccine programmes be made a priority. In India, a large number of deaths were reported during the H1N1 outbreak from 2009 onwards. Infection in pregnant women led to deaths in their third trimester. The Maharashtra government has introduced seasonal flu vaccine for high-risk groups including pregnant women. Season flu vaccine, which includes the pandemic H1N1 strain, is a priority vaccine for use in high-risk groups in India including pregnant women.

The last is the cholera vaccine. Though interventions for the prevention and control of cholera (including an oral vaccine produced and licensed in India) are available, cholera remains an important cause of morbidity and mortality. It is estimated that there are about 7-8 lakh cases every year resulting in about 20,000-24,000 deaths. About 400-500 million people are at risk. Outbreaks occur after the monsoon. Though the oral vaccine is available in India, there has been limited use.

Targeting seven diseases

The UIP is now a much strengthened programme, supported by a transparent system of taking decisions to introduce new vaccines, being sensitive to adverse events following immunisation and with the capacity to add additional vaccines. Through Mission Indradhanush [to cover, by 2020, children who are either unvaccinated, or are partially vaccinated against diphtheria, whooping cough, tetanus, polio, tuberculosis, measles and hepatitis B], India aims to be on track to increase routine immunisation coverage to 90 per cent within a few years. The years to come may well be the golden years of immunisation in India.

After PM’s rap, officials get target to clear up to 30 grievances a week

Senior officials have been assigned a new Key Result Area (KRA)to personally resolve 10-30 public grievances a week — a move that could be construed as a strategy to sensitise officials and improve public perceptions of the NDA government.

Following a rap from Prime Minister Narendra Modi over the abysmal handling of public grievances in some departments, the Cabinet Secretariat has issued a fresh order asking the Secretaries of all departments, involved an interface with the public at large, to personally address 10 individual problems in their domains every week. Officers of the rank of Additional Secretary and Joint Secretary have been tasked with resolving 20 and 30 citizen complaints a week respectively.

This new KRA has been added to e-Samiksha, an IT-based governance platform through which the Prime Minister monitors and can red-flag the performance of the Ministries on different targets.

Top priority has been given to this directive, with the Prime Minister expected to review it from this month’s Pro-Active Governance and Timely Implementation (PRAGATI) meeting, where he interacts with Central government Secretaries and the Chief Secretaries of the States and assesses the progress based on inputs from e-Samiksha and other sources, including the Ministry of Statistics and Programme Implementation.

Citizens’ complaints about government agencies are handled by the Department of Administrative Reforms and Public Grievances in the Ministry of Personnel and the Directorate of Public Grievances at the Cabinet Secretariat. A web-based Centralized Public Grievance Redress and Monitoring System (CPGRAMS) forwards complaints to the departments concerned for remedial action, tracking them till their resolution.

“At January’s PRAGATI meeting, the Prime Minister recommended strict action against officials responsible for complaints and grievances, taking exception to the high complaints arising from the Customs and Excise Departments. He had asked all Secretaries whose departments have extensive public dealings to set up a system immediately for top-level monitoring of grievances,” said an official aware of the development.

“We hope senior officials’ direct attempts at redressing grievances would help them identify more systemic flaws that can be addressed by changes in administrative processes and cumbersome rules, so that grievances of such type can be prevented rather than be resolved post-facto,” he said of the decision to make officers above the rank of Joint Secretary responsible for grievances.

At the PRAGATI review meetings, the Prime Minister monitors the pendency of CPGRAMS grievances. A new module has been added to include the details of grievances addressed by top officials in each department. As per the new norms, Joint Secretaries would have to report the status of 120 public grievances a month, while the number would be 80 for Additional Secretaries and 40 for Secretaries.

An analysis of grievances received on CPGRAMs highlights that a key reason for complaints is the archaic rules, regulations and instructions aimed at shifting the work towards citizens. “Slackness in administration, low morale of the services, inherent inertia, absence of incentives, lack of proper authority and accountability are the delay-breeders, and the delay is the major factor for grievances. Many times, the departments avoid taking decisions by resorting to rejection without application of mind, and lay stress on disposal, and not on the quality disposal. There is inertia to review decisions taken by down-the-line functionaries,” the Department of Administrative Reforms and Public Grievances has noted as key factors for the persistent red tape-related woes in government offices.

India coughs up a cold call: no more sweet nothings

The fall from grace for codeine — once the world’s most lauded cough medicine — had begun nearly half a century ago before it was formally tombstoned by India earlier this week. Corex, a cough syrup whose most important element is codeine and one of pharma major Pfizer’s most profitable drugs in India, was banned along with 300-odd so-called fixed-dose combination (FDC) drugs .

Until the early 20th century, when the world had yet to discover antibiotics and pneumonia and tuberculosis were major killers, physicians often chose to alleviate suffering and prescribed narcotics to address cough, especially the racking, convulsive variety that characterised tuberculosis. When the hallucinogenic morphine seemed to be the only effective solution, codeine emerged in 1832, in the lab of French chemist Pierre Robiquet, as a white knight that promised a restful, relaxed sleep. It was also a breakthrough in chemistry and among the first artificially synthesised drugs educed from opium. Over time, however, its side effects — of being extremely addictive and inducing drowsiness — became such a problem that Heroin (the highly regulated narcotic of today) and a drug developed by German drug manufacturer Bayer was actually sold as the “non-addictive” version of codeine and “10 times more effective as cough medicine”, according to Richard Askwith, in The Sunday Times (U.K.) of September 1998.

Relief at a high cost

Coughs usually occur when people catch a cold and they are nature’s method of protecting our airways, of inducing a reflex response to any irritation in our throat. A cough can linger for up to two weeks as the upper airways are inflamed by the cold virus and mucus trickling down the back of the throat. Cough syrups either try to suppress it or help cough up phlegm. Cough suppressants such as codeine and dextromethorphan directly act on the brain regions responsible for triggering the coughing reflex.

Their mechanism may be simple but while promoted as agents of relief by drug companies, the onset of antibiotics to cure infectious diseases that often had cough as a symptom, also began to throw up a body of medical literature in the 1950s that showed that cough syrups did little to help with the underlying causes of disease and could do more harm than good.

Once ingested, codeine could be rapidly converted to morphine within the body and that could dangerously spike blood levels, especially in children, and reports also started to emerge of its role in hypoxia — or decreased oxygen supply to the brain.

Worse, given its opioid ancestry there were always clinical observations that cough syrups in high doses caused hallucinations, dizziness and were extremely addictive and reports also began to emerge of its popularity as a street drug because of its easy availability in pharmacies. A comprehensive review last year by the U.S. National Institute of Drug Abuse says: “Abusing Dextromethorphan, or DXM (a cough suppressant developed in the ’50s as an alternative to codeine formulations), can cause impaired motor function, numbness, nausea or vomiting, increased heart rate and blood pressure, and at high doses, extreme agitation, increased body temperature, and a build-up of excess acid in body fluids.”

Corex’s recent ouster is connected to a large crackdown by the government on FDCs that are medicines in which two or more active pharmaceutical ingredients (APIs) are combined to form a single drug. Though the combined action of multiple drugs ought to mean improved efficacy, critics says that a combination is a new drug that could lead to unknown side effects.

A socio-cultural problem.

For one, say medical practitioners, Indians are psychologically addicted to prescriptions. Dr. C.M. Gulhati, editor, Monthly Index of Medical Specialities (India), an influential reference guide on drugs and clinical trials, has for several years been arguing that India is “unique” among all the countries in its fixation with “irrational” drug combinations. “In my experience, several patients are dissatisfied if they haven’t been prescribed a certain number of medicines and think a doctor is unfit if he asks for tests before prescribing pills,” he says, “and that’s got to do with doctor fees being usually more than the cost of recommended medicines.”

The World Bank notes that over 85 per cent of the out-of-pocket expenditure of Indians is on private health care. Moreover, to save on a visit to the doctor, Indians are notoriously prone to what Dr. Gulhati terms the “disease” of self-medication. “The combination of poverty, privatised health care and corruption is what’s responsible for the rise of irrationally prescribed medicines in India.” Coupled with lax laws governing the regulation of drugs in India, this opens to the door to pharmaceutical companies entering the doctor-patient interface and significantly influencing the medicines that are being consumed, he adds.

Listing what is permissible

While addressing foundational problems with the state of Indian health care may take time, a more rational way would be for India’s drug regulator to get its act together. “Instead of banning drug formulations, a better way would be list out permissible drug formulations by basing it on efficacy and potency,” says Dr. Sengupta. There are nearly 6,000 FDCs available across the country and imprecise legislation over the years has meant that States — and not the Centre — have usually had the power to vet which formulations were permissible. They gained in popularity due to laws in the 1980s that made it more profitable for companies to sell FDCs than single drugs, though such caps have now been lifted.

In the meantime, there are better ways to treat cough. Dr. Gulhati says that the aim of most cough medication is to soothe the throat and that can be achieved through home remedies such as honey and warm water.

UNESCO updates protected biosphere reserves list

The United Nation’s cultural body UNESCO has added 20 new sites to its network of protected biosphere nature reserves, including two in Canada and two in Portugal.

The status was conferred during a two-day meeting in Lima that ended on Saturday, which brought the total number of biosphere reserves to 669 across 120 countries.

In Canada, the Tsa Tue area in the country’s Northwest Territories that includes the last pristine arctic lake was added to the list, as was the Beaver Hills region of Alberta, which has a landscape formed by a retreating glacier.

Britain’s Isle of Man, located in the Irish Sea in a biologically diverse marine environment, and Mexico’s Isla Cozumel were also selected for the network.

And in Portugal, the entire Island of Sao Jorge, the fourth largest in the Azores Archipelago, was designated a reserve in addition to the Tajo River region between Portugal and Spain.

The list of new UNESCO biosphere reserves also includes sites in Algeria, Ghana, Haiti, India, Indonesia, Iran, Italy, Kazakhstan, Madagascar, Morocco, Peru, the Philippines and Tanzania.

Of the hundreds of locations on the list, 16 are sites that stretch across more than one country. Spain is the country with the largest number of registered reserves.


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