MultiDrug Resistant Tuberculosis: The Challenge of Adherence among Women in Uganda

In 2018, there were over 484,000 cases of MultiDrug Resistant Tuberculosis recorded around the world, which contributed to 44.21% of deaths caused by tuberculosis. Women diagnosed with MDR-TB are more vulnerable to low mental and social well-being than men, it is imperative that immediate action be taken to address the difficulties experienced by female patients as well as their support networks. This can be accomplished by putting emphasis on ’patient-centered care’, and a strong Primary Health Care system that is adequately facilitated would go a long way in ensuring efficient prevention and response to MDR-TB especially among women. 

By Christopher Ogwang

Christopher Ogwang

Multi-drug-resistant tuberculosis (MDR-TB) is a major public health hazard on a global scale. It is a kind of tuberculosis (TB) infection caused by bacteria that are resistant to treatment with at least two of the most powerful first-line anti-tuberculosis (anti-TB) medications. This is caused by non-adherence to the treatment regimen or poor prescription. In 2018, there were over 484,000 cases of MDR-TB recorded around the world, which contributed to 44.21% of deaths caused by tuberculosis. Over 62% of these instances were not treated, which is more than half. Noteworthy, the treatment of MDR-TB is much more expensive than the treatment of susceptible TB. In Uganda, various health challenges impede the scale-up of Drug-Resistant Tuberculosis treatment and care, treatment is either inadequate or lacking and in some cases, diagnosed patients delay on the treatment waiting list. Having one or more drug stock outs in health facilities treating susceptible TB was significantly associated with the risk of developing MDR-TB which has been noted as one of the factors contributing to poor outcomes and risk of developing drug-resistant TB, especially in rural communities. 

Women diagnosed with MDR-TB are more vulnerable to low mental and social well-being than men. Married women and women of childbearing age are most vulnerable to MDR-TB’s socio-economic, and mental health consequences, such as isolation, financial difficulties, and despair. Besides the intricacies and length of treatment, psychosocial difficulties frequently aggravate MDR-TB. It is essential to broaden patients’ access to psychotherapy and other forms of mental healthcare while they are undergoing treatment for MDR-TB.

The reproductive and parental roles of women and mothers compound the difficulties they already face in coping with, remaining adherent to, and ultimately benefiting from MDR-TB treatment. In most cases, a female patient is also a wife or mother who provides essential care for other members of her family, including those who also suffer from MDR-TB. Women have the social obligation to care for their sick children and spouses, but they may be denied even the most fundamental needs when they are ill themselves.

It is imperative that immediate action be taken to address the difficulties experienced by female patients as well as their support networks. This can be accomplished by putting emphasis on the requirement for ’patient-centered care’” and enhancing the services offered at local health facilities that are closer to the patients. This would cut indirect related costs associated with treatment that female patients may not be able to afford. This is critical because most women are incapable of maintaining adherence to the treatment regimen, yet worse when it comes to women in rural areas that mainly engage in unpaid care work and have no room to create and focus on income streams.

Along the therapy continuum, we need to emphasise  the significance of psychosocial stresses and social support as intermediary predictors for successful treatment results. To be able to ensure that female patients have a supportive environment to sustain adherence, families, patients and their family members should each receive the appropriate health information relevant to the condition and treatment plan in order to establish a support system that is both enabling and supportive. This is critical in sustaining adherence to treatment and care for Tuberculosis.

In addition, in order to improve the overall level of care provided, the screening for and treatment of mental health disorders should be incorporated in the national recommendations for the management of MDR-TB cases.

There is need to develop and implement a comprehensive mechanism for contact tracing of new tuberculosis cases and defaulters, implement an all-inclusive surveillance system such as the community awareness, screening, testing, prevention and treatment to combat TB. As evidenced from the work by the Center for Health, Human Rights and Development (CEHURD) contact tracing in northern Uganda, continuous tracing and reintegration into treatment saves lives not just of those who had dropped out of treatment but also the ones in their communities. A strong Primary Health Care system that is adequately facilitated would go a long way in ensuring efficient prevention and response to MDR-TB especially among women. 

The writer is a Senior Programme Officer at the Center for Health, Human Rights and Development (CEHURD).

Pfizer says to appeal over India drug patent refusal

US drug giant Pfizer said Friday it will appeal against an Indian ruling overturning a patent for a cancer drug, saying the decision raises questions about intellectual property protection in India.

 

Indian generics heavyweight Cipla opposed the granting of the domestic patent for Prizer’s Sutent, which is used to combat liver and kidney cancer.

The patent office’s decision went to the heart of India’s patent act, which says a patent cannot be granted for a drug unless changes make it significantly more effective and innovative.

“The patentee (Pfizer) has miserably failed to demonstrate any improved activity” warranting a patent, the patent office said in its decision.

“The invention that is claimed in the patent does not involve any inventive step… and hence (is) not patentable,” Nilanjana Mukherjee, senior patent officer, said.

A spokesman for Cipla, which revolutionized AIDS treatment by supplying cut-price drugs to the world’s poor and which has been campaigning to be able offer other low-cost generic medicines, had no immediate comment.

But Pfizer managing director Jazz Tobaccowalla said the company believes the ruling “undermines intellectual property rights in India”.

“We will vigorously defend our basic Sutent patent,” the Pfizer executive said in a statement, adding the company would appeal against the ruling to India’s Intellectual Property Appellate Board.

The patent decision marked another win by Cipla against a global pharmaceutical company.

In September, a court threw out a patent infringement case launched against Cipla by Swiss drug maker F. Hoffmann-La Roche over the Mumbai firm’s version of a lung-cancer drug, ruling it had a different molecular makeup.

The cases have been watched worldwide as they involve interpretation of stricter drug patent protection rules introduced by India in 2005 to comply with World Trade Organization regulations.

India has some of the toughest criteria for drug companies to obtain patents, said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, an industry body.

“These rulings show (foreign) companies need to take into account that India will not permit tweaking of formulations for getting a patent. If they had those expectations, they were unrealistic,” Shah told AFP.

Medical charities have expressed concern compliance with WTO rules could reduce the country’s role as a supplier of low-cost medicines. India is the world’s leading exporter and manufacturer of non-branded medicines.

But Western firms — looking to countries such as India for sales growth — have voiced criticism of brand protection in India.

Earlier this year, an Indian ruling allowed a local firm to produce a vastly cheaper copy of German pharmaceutical giant Bayer’s patented drug Nexavar for liver and kidney cancer.

India’s patents chief ruled the price Bayer charged was “exorbitant” and told the firm to give a “compulsory license” — permitted under WTO rules for public health reasons — to Indian firm Natco Pharma to make a less costly version.

Experts say that ruling could pave the way for a rush of other “compulsory license” applications in India and other poor nations, allowing access to patented life-saving drugs at a fraction of the cost.

Read more: http://india.nydailynews.com/business/678d561f1bf06eab53965176d7bfd4cf/pfizer-to-appeal-over-india-drug-patent-refusal#ixzz28ZbSjQ00

Indian patent rules infuriate Big Pharma

A CLASH over India’s drug market was inevitable. Foreign drugmakers, facing paltry growth in the West, are eyeing India hungrily. Rising incomes and rates of chronic disease may push sales from $12 billion in 2010 to $74 billion in 2020, according to PwC, a consultancy. But tapping this growth means having patents that protect intellectual property. India is home to a thriving generics industry, whose copycat drugs make up about 90% of the market. India’s drug-patent laws are just seven years old. Its government is keen to encourage generics and keep prices down.

Now India’s patent rules are being put to the test. Novartis, a Swiss giant, is challenging India for denying a patent for Glivec, its blockbuster cancer drug. The fight is due to reach India’s Supreme Court on September 11th. Bayer, a German drugmaker, has a different problem: in March India’s patent controller ordered it to license a drug to a local manufacturer. Its appeal had its first hearing on September 3rd. The cases will help decide how quickly India’s 1.2 billion people get new drugs, and at what price.

India’s drug industry has a unique history. For more than 30 years, the country did not recognise pharmaceutical patents. Domestic firms became masters at copying medicine and making it cheaply. After joining the World Trade Organisation (WTO) in 1995, India had to change its patent policy. But its new system, in place since 2005, includes special protections for both patients and generic manufacturers.

For example, the law bars patents of minor changes to existing drugs, a practice known as “evergreening”. Drug reformulations are often used to extend patents elsewhere; they get no protection in India. The country also has broad criteria for “compulsory licensing”. A WTO agreement allows countries, in some instances, to force a firm to license a patented drug to a generic company. India’s rules give officials broad powers to do this.

Now both provisions are under attack. In 2006 India denied Novartis a patent for Glivec, calling it an unpatentable modification of an existing substance, imatinib. Novartis insists this is nonsense. Only by making it in salt form, imatinib mesylate, did Novartis have a proper drug: the body absorbed the medicine 30% more easily.

Paul Herrling, the chair of Novartis’s Institute for Tropical Diseases, says the case is a test of what is patentable in India. “We are being accused of evergreening,” he says. “Having that concept applied to Glivec, which was one of the major breakthroughs in cancer therapies, is completely ridiculous.” Michelle Childs of Médecins Sans Frontières, a non-profit, retorts that drug firms such as Novartis should not win patents for minor improvements. This would keep generics off the market, driving up prices.

Bayer’s case is equally heated. In 2008 it won an Indian patent for Nexavar, a kidney-cancer drug. But in March India’s patent controller issued the country’s first compulsory licence. He wrote that Bayer had not made Nexavar “reasonably affordable” (Bayer offered it for a whopping $5,000 a month), that the company failed to provide enough of the drug and, in a protectionist nod, reckoned that importing Nexavar further hurt Bayer’s case. The controller ordered an Indian company, Natco, to sell Nexavar for one-thirtieth of Bayer’s price. Bayer will receive a 6% royalty. Meanwhile Bayer is fending off another competitor, Cipla, which has sold generic Nexavar in India for years.

As these cases drag on, India’s government is considering other ways to get cheaper medicine. It plans to offer free generics in public hospitals, which would drive up sales of very cheap copies. It may also set price controls for patented drugs. However, generic companies are not immune to regulatory pressure. Ministers plan to expand price controls for a broader swathe of generics.

Cost versus innovation

 

 

“We realise the industry will take a hit,” explains D.G. Shah of the Indian Pharmaceutical Alliance, which represents big generic companies. “We’re trying to find a solution so that the government’s concerns on access and affordability are addressed without threatening the long-term growth of the pharmaceutical industry.” Nice work, if they can get it.

Source: http://www.economist.com/node/21562226

Court rules for Cipla against Roche in patent case

MUMBAI: A court has ruled in favour of local drugmaker Cipla in a patent infringement case filed by Switzerland’s Roche Holding AG over Cipla’s cancer drug Erlocip, a senior executive of the Indian company said.

The Delhi High Court made the ruling a week before India’s Supreme Court is due to begin hearing a patent plea by another Swiss drugmaker, Novartis AG, over its cancer drug Glivec. That case is expected to set a precedent for the Indian drug market, where major western companies are fighting to protect their intellectual property.

“The court judgement says we have not infringed any patent,” S. Radhakrishnan, a director on Cipla’s board, told Reuters late on Friday after the Delhi High Court’s ruling.

Roche accuses Cipla of infringing its patent on cancer drug Tarceva, which Cipla sells under the brand name Erlocip.

Roche could not immediately be reached for comment. The company has the option to challenge the judgement in India’s Supreme Court.

The ruling comes nearly four years after the court rejected Roche’s attempt to stop Cipla from selling Erlocip in India.

The court, however, said that Roche’s patent over Tarceva is valid in India, media reports said.

Source: http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/court-rules-for-cipla-against-roche-in-patent-case/articleshow/16302523.cms

HIV/AIDS bell tolls

BY HENRY ZAKUMUMPA

The delay in reforming a critical Bill in parliament may render AIDS drugs in Uganda illegal

We no longer fear AIDS. Eddagala gyelili e Mulago (drugs are available at Mulago Hospital),” says Ssenkindu Moses, 32,  who tells me he has had three sexual partners in the last one month and did not use condoms with any of them.

Many Ugandans take AIDS treatment for granted. This ‘ARV complacency’ has been partly blamed for the recent spike in new HIV infections. Uganda’s HIV prevalence rates have risen from 6.7% in 2005 to the current 7.3%.

Because most antiretroviral treatment (ART) in Uganda has been funded by the American taxpayer, with PEPFAR paying for as much 85% of all AIDS treatment costs in Uganda, you would regard financial sustainability as the challenge to continued access to treatment in Uganda. But you would be mistaken.

According to Dennis Kibira, Medicines Advisor at HEPS, a local NGO, 90% of AIDS drugs in Uganda are generic drugs.

A generic drug is an identical copy of a branded one that is usually developed and manufactured by innovator pharmaceutical giants such as Pfizer and Norvatis.

Pharmaceutical giants invest millions of dollars in developing and marketing new drugs, costs which generic drug manufacturers don’t incur and hence branded drugs are many times the cost of generics.

“Unless the Ugandan parliament revises and re-introduces the Industrial Properties Bill (2009), the permission to manufacture cheap generic ARV drugs will cease in 2016 with thousands affected since Quality Chemicals manufactures generic Aids drug,’’ said Moses Mulumba, Executive Director of CEHURD, a health rights advocacy NGO.

India which supplies most of Uganda’s AIDS drugs, has developed a thriving generics industry, leading to it being dubbed “the pharmacy of the developed world” for the low cost of its generic drugs, especially antiretrovirals, some of which cost as little as a tenth of the brand price.

For developing countries such as India, the ban on manufacture of generic Aids drugs came into force in 2005 under the TRIPS agreement of the WTO whereas a similar ban on poorer developing countries such as Uganda will take effect in 2016 unless the Ugandan parliament revises the industrial properties bill (2009) which would, inter alia provide for extension of this deadline.

According to the WHO, ‘Developing countries are failing to make full use of flexibilities built into the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to overcome patent barriers and, in turn, allow them to acquire the medicines they need for high priority diseases, in particular, HIV/Aids.

With the expiry of the TRIPS grace period, the alternative in Uganda would be to buy these drugs much more expensively from the original western manufacturers.

At the moment, passing the Industrial Properties Bill (2009) in Uganda, after amending it to take full advantage of the ‘flexibilities’ in the TRIPS agreement would, inter alia, extend the grace period for manufacturing generic Aids drugs remains the best hope for the thousands on Aids treatment in Uganda.

In November last year, a consortium of NGOs led by CEHURD took out a half page newspaper appeal to Kahinda Otafiire, the Justice minister to seek his support in revising the bill before it is passed by parliament.

“The bill left our desk. We did our part. It is now before parliament, specifically before the legal affairs committee” sources within the Ministry of Justice said.

However, the Bill which was brought before the committee in 2009 has not been enacted since and the Bill lapsed with the 8th parliament. The Industrial Properties Bill (2009) has now been inherited by the current parliament. The Ministry of Justice, however, indicated that a Bill should not spend more than 45 days before a committee of parliament.

“As stakeholders, we are waiting for the public hearing on this bill. However, since April this year when the Expert Report on this bill was released by Ministry of Trade, there have been no engagements on this Bill by the 9th Parliament,” says Mariam Akiror of HEPS-Uganda.

“Laws take time to enact as you have to follow so many procedures including the draft being presented before cabinet and even formulating policy and objectives and parliament has many priorities,” says a Uganda Law Reform commission official. However, ‘big pharma’ interests are always a part of the story.

Mariam Akiror of HEPS Uganda insists that the Bill as it is would  do more harm than good and even suggests that the status quo is preferable as ‘big pharma’ would be hard-pressed to enforce their patents in the current legal regime. In the current Bill, government would need the consent of a patent holder before making a generic drug yet the TRIPS flexibilities permit poor countries to make a copy without permission on account of a public health emergency.

Charles Birungi of UNDP(Uganda) insists that the current Bill is about “enforcement of certain types of intellectual property rights” which are private rights enjoyed mainly by western pharmaceutical giants. Revising the Bill would be a boost for Ugandan pharmaceutical industries such as Quality chemicals as it would legalize their production of generics.

“There are few priorities before parliament which should take precedence over our very lives as Ugandans. If I was an MP, this bill would be the most important item on the agenda because it affects millions of Ugandans. Look at how many Ugandans are getting infected every day and how many will need these drugs?” asks a dejected Gertrude Namusisi, 42, who is living positively with HIV/AIDS.

Henry Zakumumpa works with Makerere University and is 2011 Media Fellow of the Center for Health, Human Rights and Development (CEHURD).

zakumumpa@yahoo.com

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