By Jomo Kwame Sundaram
ROME, Dec 11 2015 (IPS)

The latest estimates are that over two billion people in the world suffer some micronutrient deficiencies, often referred to as “hidden hunger.” The main sustainable solution is to ensure adequate public health interventions, including clean water, sanitation and hygiene as well as healthy, diverse diets for all.

Jomo Kwame Sundaram. Credit: FAO

In the short term, however, it will be necessary to provide supplements of vitamins, minerals and trace elements to those especially vulnerable, e.g. due to displacement and emergency situations. There is a general consensus that such needs of pregnant and lactating mothers should be especially prioritized due to the intergenerational consequences of child stunting for such reasons.

Developing countries should be able to affordably access locally produced or imported generics of the vitamin and mineral supplements they require. Many current options associated with public-private partnership will instead strengthen the vested interests of the lucrative, large and fast-growing industry for nutrition supplements.

The need for supplementation to address urgent, short-term micronutrient deficiencies should qualify as part of the public health exception to the Trade-Related Aspects of Intellectual Property Rights (TRIPs) rules of the World Trade Organization (WTO). This has not been fully recognized ostensibly because people do not drop dead immediately due to “hidden hunger.”

TRIPS and generics production for developing countries

Under the TRIPS agreement, intellectual property rights (IPRs) — for copyright, trademark, geographical indication, industrial designs and patents — are extended to all signatory countries. Patents, most relevant to public health and access to medicines, give twenty years of protection to inventions.

In the current language, there are no explicit provisions for generic production of patented nutrition supplements. However, there is supposed to be a great deal of flexibility on the basis of public health needs, which could be extended to minerals and vitamins for supplementation.

The TRIPS Agreement provides space for countries taking measures to protect public health. Under Article 31, countries can issue compulsory licenses allowing firms or individuals to produce generic copies of patented products or processes for the domestic market without the owner’s consent in “case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.” The government can also determine adequate payment to the IPR holder.

At the Doha WTO conference in 2001 launching the Doha Development Round of trade negotiations, the Declaration on the TRIPS Agreement and Public Health affirmed the right of countries to protect public health, enable access to medicines, and determine the criteria for issuing a compulsory license. It emphasized that each country “has the right to grant compulsory licenses” and “the right to determine what constitutes a national health emergency or other circumstances of extreme urgency.”

This new text corrected the false impression that some health emergency was needed to justify compulsory licensing. It also spelt out that “public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.”

Technology transfer

Under Article 66.2 of TRIPS, developed country governments are obliged to actively promote technology transfer in establishing manufacturing capabilities for patented processes in developing countries. The 2001 Declaration also reaffirmed the developed countries’ commitment to provide incentives to their corporations to enable technology transfer to the least developed countries. This was part of the original bargain for developing countries to provide protection of IPRs.

Developing countries also have the right to import generics if they lack manufacturing capabilities. A 2003 waiver allows countries unable to domestically produce pharmaceuticals to import them instead. Hence, under compulsory licensing, such countries can import externally produced patented drugs. Thus, while compulsory licensing allows countries to import cheaper generics from countries already producing them, to take advantage of TRIPS Agreement flexibility, countries need to legislate accordingly.

However, exemptions to pharmaceutical patent protection to the least developed countries, enabling them to import without issuing a compulsory license, were only extended until 2016. The upcoming Nairobi WTO ministerial should extend this exemption beyond next year.

While there appears to be legal space under TRIPS for developing countries to use compulsory licensing, they have effectively be prevented from doing this by complicated rules and procedural requirements. Consequently, use of compulsory licensing by developing countries has been largely limited to HIV/AIDS medicines, and almost exclusively used by middle-income countries. LDCs have not issued any compulsory licenses while the total number of applications has declined significantly in the last decade.

Needed actions

Existing TRIPS texts do not preclude compulsory licensing for local generic production in developing countries. However, extension of the right to use compulsory licensing and other such flexibilities to vitamin and mineral supplements is not explicit. While explicit permission is given to AIDs, malaria, tuberculosis and epidemics, even this is rarely used.

In light of the foregoing, the following revisions to WTO provisions to protect developing countries’ right to produce generic vitamin and mineral supplements should be introduced. This will also be in line with the July 2015 Addis Ababa Action Agenda’s commitment to facilitate technology transfer:

• Developing appropriate model legislation to facilitate development of the national legislation needed for compulsory licensing, etc.
• Provide free legal services to developing country governments interested in accessing TRIPS facilities.
• Identify and investigate relevant national vitamin and mineral supplement production needs in partnership with other governments to enable developed countries to meet their technology transfer obligations.

Developing countries need to act to overcome three major constraints to issuing compulsory licenses and bypassing patent legislation for public health. First, the governments must be strong enough to withstand business and political pressures. Second, it is necessary to have enabling legislation in place. Third, these countries need to have production capacity and distribution arrangements in place.
Also, the UN system should offer appropriate technical expertise to advance progress.

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Excerpt:

By Germán Velásquez
GENEVA, Nov 10 2015 (IPS)

The important relationship between the examination of patents carried out by national patent offices and the right of citizens to access to medicines hasn’t always been well-understood. Too often these are viewed as unrelated functions or responsibilities of the state. And the reason is clear: patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators.

Germán Velásquez

Given the impact of pharmaceutical patents on access to medicines, patent offices should continue to align their work in support of national health and medicine policies, using the freedom permitted by the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) to define patentability requirements.

The TRIPS Agreement requires all World Trade Organization (WTO) member states to incorporate into their legislation universal minimum standards for almost all rights in this domain: copyright, patents and trademarks.

A patent is a title granted by the public authorities conferring a temporary monopoly for the exploitation of an invention upon the person who reveals it, furnishes a sufficiently clear and full description of it, and claims this monopoly.

As with any monopoly, it may lead to high prices that in turn may restrict access. The problem is compounded in the case of medicines, when patents confer a monopoly for a public good and essential products needed to prevent illness or death and improve health.

According to the TRIPS Agreement, the patentability requirements used by national intellectual property offices require a product or manufacturing process to meet the conditions necessary to grant patent protection, namely: novelty, inventive step and industrial applicability (utility).

These three elements, however, are not defined in the TRIPS agreement and WTO Member States are free to define these three criteria in a manner consistent with the public health objectives defined by each country.

It is widely held that patents are granted to protect new medicines to reward the innovation effort. However, the number of patents obtained annually to protect truly new pharmaceutical products is very low and falling. Moreover, of the thousands of patents that are granted for pharmaceutical products each year, a few are for new medicines – e..g. new molecular entities (NMEs).

All of the above led the World Health Organization (WHO), in collaboration with the United Nations Conference on Trade and Development (UNCTAD), the United Nations Development Programme (UNDP) and the International Centre for Trade and Sustainable Development (ICTSD), to develop, in 2007, guidelines for the examination of pharmaceutical patents from a public health perspective.

The guidelines were intended to contribute to improving the transparency and efficacy of the patent system for pharmaceutical products, so that countries could pay more attention to patent examination and granting procedures in order to avoid the negative effects of non-inventive developments on access to medicines. The major problems can be identified in the current use of the patent system to protect pharmaceutical innovation: reduction in innovation, high prices of medicines, lack of transparency in research and development costs, and proliferation of patents.

A study carried out by the journal Prescrire analysed the medicines that were introduced to the French market between 2006 and 2011, arriving at the conclusion that the number of molecules that produced significant therapeutic progress reduced drastically: 22 in 2006; 15, 10, 7, 4 in the following years up to 2011, which was a year in which Prescrire declared that only one medicine of significant therapeutic interest was brought to the market. Given that France is one of the largest pharmaceutical markets in the world, the reduction in innovation confirmed France is a good indicator of the global situation.

Oncologists from fifteen countries recently denounced the excessive prices of cancer treatments, which are necessary to save the lives of the patients, and urged that moral implications should prevail; according to them, of the 12 cancer treatments approved in 2012 by the United States Food and Drug Administration, 11 cost more than 100,000 dollars per patient per year.

Since the 1950s, there have been some references to the costs of Research and Development (R&D) for pharmaceutical products. According to some sources the average cost of research for a new pharmaceutical product these figures have increased from 1 million dollars in 1950 to 2.5 billion dollars for the development of a single product.

During the summer of 2014, a number of European countries, including France and Spain, spent many months negotiating with the company Gilead on the price of a new medicine for hepatitis C known as Solvaldi. The price fixed by Gilead was 56,000 Euros per patient for a twelve-week treatment, or 666 Euros per tablet. According the newspaper Le Monde the price of each tablet was 280 times more than the production cost. In France, it is calculated that 250,000 patients should receive this medicine, the cost of which would represent 7 per cent of the annual state medicine budget.

The application of patentability requirements for medicines, given their public health dimension, should be considered with even more care than in the case of regular merchandise or luxury items. The first and most important step is to use the freedom permitted by the TRIPs Agreement to define the patentability requirements: novelty, inventive step and industrial applicability (utility) in a way that keeps sight of public interest in the wide dissemination of knowledge.

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Excerpt:

Many pharmacies and herbalists in Egypt prescribe their own 'wasfa' (secret drug or herbal elixir). Credit: Cam McGrath/IPS

By Cam McGrath
CAIRO, Aug 10 2014 (IPS)

Magda Ibrahim first learnt that she had endometrial cancer when she went to a clinic to diagnose recurring bladder pain and an abnormal menstrual discharge. Unable to afford the recommended hospital treatment, the uninsured 53-year-old widow turned to what she hoped would be a quicker and cheaper therapy.

A local Muslim sheikh claimed religious incantations, and a suitable donation to his pocket, could cure the cancer. But when her symptoms persisted, Ibrahim consulted a popular herbalist, whose wasfa (secret drug or herbal elixir) was reputed to shrink tumours.

“I felt much better for a few months and thought the tumour was shrinking,” she says. “But then I got much worse.”

When she returned to hospital the following year, tests revealed that the tumour was still there, and the cancer had spread to her lymph nodes. Moreover, the herbal mixture she was taking had caused her kidneys to fail.“Successive [Egyptian] governments have done a poor job at both regulating the medical sector and educating the public on health issues, leaving Egyptians unable to afford their country’s two-tiered health care system vulnerable to ill-qualified physicians, spurious health claims and quackery” – Dr Ahmad Bakr, Egyptian health care reform lobbyist

Egypt is a “minefield” of bad medicine, says paediatrician Dr Ahmad Bakr, a health care reform lobbyist. He says successive governments have done a poor job at both regulating the medical sector and educating the public on health issues, leaving Egyptians unable to afford their country’s two-tiered health care system vulnerable to ill-qualified physicians, spurious health claims and quackery.

“Our health care system is deeply deformed,” Bakr told IPS. “It’s not just a matter of low funding and corruption, ignorance (pervades every tier of) the health system, from government and doctors to the patients themselves.”

He says Egypt’s lax regulation and poor enforcement has created room for unqualified doctors to perform plastic surgery out of mobile clinics, peddle snake tonic on satellite television, and dabble dangerously in reproductive health.

It is estimated that one in every five private medical clinics in Egypt is unlicensed, and thousands of medical practitioners are suspected of using false credentials or having no formal training.

“There are a lot of so-called doctors who practise medicine in Egypt,” says Bakr. “They mostly work out of small clinics, but you’ll even find them in the most prestigious hospitals.”

The incompetency goes all the way to the top.

In February, Egypt’s military announced it had invented a device to remotely detect hepatitis C – along with acquired immunodeficiency syndrome (AIDS), swine flu and a host of other diseases. The device, which is said to work by detecting electromagnetic waves emitted by infected liver cells, is based on a fake bomb detector marketed by a British con artist.

The military also claimed that it had invented a revolutionary blood dialysis machine that can cure hepatitis C, AIDS and even cancer in a single treatment.

“I was shocked when I saw these incredible claims were being made with barely any clinical evidence,” says Dr Mohamed Abdel Hamid, director of the government-run Viral Hepatitis Research Lab (VHRL). “With any new medical treatment you should perform peer-reviewed, double-blind clinical trials before announcing it.”

Critics say Egypt’s government contributes to a climate of medical irresponsibility. State media routinely exaggerates health threats and feeds public hysteria, while the knee-jerk reactions of government authorities – including high-ranking health officials – are coloured by popular sentiment and political motives.

Reacting to the global swine flu pandemic in 2009, overzealous parliamentarians passed a motion to slaughter all of Egypt’s 300,000 pigs.

There was no evidence that pigs transmitted swine flu to humans, nor had the virus been detected in Egypt. But officials, swayed by the Islamic prohibition on eating pork, appeared to seize the opportunity of a like-named virus to rid the Muslim-majority nation of its swine.

“The pigs were kept almost exclusively by poor Christian zebaleen (rubbish collectors), who used them to digest the organic waste,” says Milad Shoukri, a zebaleen community leader. “Thousands of families lost their livelihoods to this absurd decree, which had no scientific basis.”

Global pandemics such as severe acute respiratory syndrome (SARS), avian flu and the latest contagion, Middle East Respiratory Syndrome (MERS), have presented golden opportunities for Egypt’s myriad quacks and swindlers to fleece the uninformed masses.

“With each health scare we see the same patterns,” says Cairo pharmacist Amgad Sherif. “People panic and throw science out the window. The low level of education and high illiteracy among Egyptians makes them susceptible to believe even the most ridiculous medical claims.”

When a swarm of desert locusts descended on Cairo, enterprising charlatans took out ad space in local newspapers offering a “locust vaccine” to anxious citizens.

Not surprisingly, the injected serum, which turned out to be tap water dyed with orange food colouring, offered no protection against “locust venom”. But it did leave duped households poorer, and at risk of blood contamination or hepatitis C infection from jabs with unsterilised needles.

“The people doing this only care about getting money from people who don’t know any better,” says Sherif. “They know nothing about medicine and do not follow even the most basic hygiene practices.”

In one popular scam, people claiming to be state health officials troll low- and middle-income neighbourhoods offering costly “preventative medicine” for infectious diseases. The fake medical personnel, dressed in lab coats and wearing official-looking badges, administer bogus vaccinations to unsuspecting families.

“Sometimes they give people injections – who knows what’s in them,” says Sherif.

Health officials say the sham physicians create confusion that affects legitimate health campaigns, such as Egypt’s national door-to-door polio eradication campaign.

Egyptian authorities have also found themselves in a cat-and-mouse game with thousands of “sorcerers”, whose superstition-based folk medicine draws desperate working-class patients suffering physical and psychological ailments. The self-proclaimed doctors and faith healers are particularly difficult to catch, say prosecutors, because they tend to work out of rented apartments and advertise mostly by word of mouth.

An Egyptian judicial official told pan-Arab newspaper Al Arabiya that despite attempts to prosecute sorcerers for swindling and fraud, most cases are dropped when the sorcerers reach a settlement with their victims. “There is almost one sorcerer for every citizen,” he concluded.

(Edited by Phil Harris)

"Pay to delay" agreements may cost consumers in the United States up to 3.5 billion dollars per year. Credit: Bigstock

By Carey L. Biron
WASHINGTON, Jun 17 2013 (IPS)

The Supreme Court pushed back Monday against a longstanding practise in the U.S. pharmaceuticals industry under which large-scale companies pay producers of generic copies to hold off introducing those low-cost drugs into the marketplace.

The practise, known as “reverse payments”, maintains a company’s lucrative monopoly over a drug, often resulting in significant extra income. Yet critics, including the U.S. government, have for years warned that the practise was both anti-competitive and harmful for consumers, who are forced to pay more for drugs.

While the decision did not declare reverse payments to be outright illegal, as the government had hoped, it does now allow the Federal Trade Commission (FTC) to move forward with court cases against these arrangements, known colloquially as “pay to delay”. The decision also reversed previous rulings by lower courts.

“[T]he specific restraint at issue has the ‘potential for genuine adverse effects on competition,'” Justice Stephen Breyer wrote for the majority in the 5-3 ruling. “Payment for staying out of the market keeps prices at patentee-set levels and divides the benefit between the patentee and the challenger, while the consumer loses.”

According to advocates of the changes, competition from generics can often lower drugs prices by up to 90 percent. The FTC, meanwhile, has estimated that agreements to push off such competition cost consumers some 3.5 billion dollars per year in the United States alone. "Reverse payments are a win-win for both the brand-name and generic companies."
-- Laura Etherton

Beyond setting an important legal precedent, the ruling will likely have little immediate impact outside of the United States, as the patents in question likely do not extend overseas.

Brand-name drugs comprised just 18 percent of all U.S. prescriptions written in 2011, according to statistics from IMS Health, a research company. Yet they accounted for almost three quarters of revenue for the industry, worth some 320 billion dollars a year.

“The incentives to engage in research and development are already out there without these kinds of agreements,” Scott Nelson, an attorney with Public Citizen, a public interest watchdog, told IPS.

“Signing one of these agreements will mean you may have to fight the U.S. government. Hopefully, the impact will be that companies think twice before entering into these types of agreements, which are basically just arrangements to split up profits under which consumers lose out.”

Collusive agreements

The Supreme Court decision revolves around 1984 federal legislation, known as the Hatch-Waxman Act, that was meant specifically to push generic drugs onto the market more quickly. As Nelson noted, this law offers incentives for the development of new drugs such as decades-long patents.

But it also allowed generics manufacturers to challenge these patents for a variety of reasons. According to a study by the FTC, until the early 2000s, the generics companies prevailed in these challenges almost three quarters of the time.

Yet reverse payments arrangements offered a lucrative loophole in this process.

“Today, the court echoed what I, along with many other members of Congress, have repeatedly said:  the over-arching goal of Waxman-Hatch is to foster competition in the pharmaceutical industry,” Henry Waxman, a member of the House of Representatives and co-author on the 1984 bill, said Thursday.

“The type of collusive agreement at issue in this case represents a total perversion of the spirit of this law. This is a significant victory for consumers.”

Increasingly over the past decade, brand-name drugs manufacturers have moved to counter-sue generics companies following the filing of a challenge. Typically the companies would allege patent infringement and threaten a lengthy and costly court fight.

Thereafter, the two companies would arrive at a large cash settlement – the reverse payment – along with an agreement that the generics manufacturer would not introduce any related product into the marketplace for a set period of time.

The case before the court involved a type of synthetic testosterone, called AndroGel, used by cancer sufferers and others. The brand-name version of this drug cost around 379 dollars for a month’s supply.

While the introduction of a generic version could have knocked that price down to around 40 dollars, a deal between AndroGel’s manufacturer and a number of generics companies pushed off the introduction of a low-cost AndroGel until August 2015.

“These reverse payments are a win-win for both the brand-name and generic companies, as the latter essentially gets a share of the profits but the brand name gets to hold onto its monopoly for longer than,” Laura Etherton, a health policy analyst with U.S. PIRG, a consumer rights advocacy group, told IPS.

“The problem is these deals are lose-lose for consumers and taxpayers, as consumers end up paying billions more for these drugs, while taxpayers are forced to foot higher bills for [social safety-net programmes]. That’s the wrong way to go about making necessary medications available for the public.”

According to information provided by U.S. PIRG, such deals have delayed the introduction of generic drugs meant to fight AIDS, cancer and high blood pressure, among other diseases.

Legislative next step

Still, for advocates like Etherton, Monday’s decision did not go far enough.

“We are disappointed the court didn’t take the next step and outright outlaw this anti-competitive practice,” she said.

“But the silver lining in not taking that next step is that the case has really raised the profile of this issue. Our hope now is that Congress will give the issue the attention it deserves and end ‘pay for delay’ once and for all.”

Two pieces of legislation are currently pending in the U.S. Senate that would crack down further on reverse payments. One would seek to reduce the incentive for generic companies to enter into “pay for delay” agreements, by allowing a second generic company to circumvent such an arrangement and bring the drug to market.

A second proposal would outlaw such payments entirely. Federal auditors estimate that such a move would save the government some 11 billion dollars over a decade, in addition to consumer costs.