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Kabale considers law to force pregnant women into hospitals

 By Robert Muhereza

Kabale District is working on a by-law to compel pregnant women to give birth at health facilities and penalise those who deliver aided by traditional birth attendants (TBAs).

District speaker Pastoli Twinomuhangi said on Wednesday that he is ready to present the draft by-law for the council’s consideration. This follows a recent survey in Rukiga, one of the four counties in Kabale District, where it was found that nearly one in every two expectant women that TBAs help to give birth, die.

“An ordinance is already being drafted to compel mothers in labour to deliver at the established government health centers in order to save their lives and that of the babies,” Mr Twinomuhangi said.

However, according to District Health Officer Patrick Tusiime, the number of women delivered by TBAs has reduced due to intensified mobilisation through media and community meetings.

Half of pregnant women in the district now deliver at health facilities, up from 12 per cent five years ago, the doctor said.

Complaints
However, Ms Allen Busingye, a businesswoman in Kabale town, said some of them prefer the services of TBAs because they offer “motherly care unlike in the health centres where we are attended to by young and abusive nurses.

“The young nurses are rude to the mothers in labour pains,” she said.

The government outlawed the traditional birth attendants, but they continue to thrive especially in rural areas where public health services are either lacking or unaffordable.

The District Deputy Resident District Commissioner, Mr Nickson Kabuye, said his office is investigating reports that some health workers in the district on government payroll extort money from women seeking antenatal care, forcing them to turn to TBAs. The culprits, he said, will soon be exposed.

TBA head responds
The head of TBAs in the district, Mr Charity Mugisha, said an accusation pinning them on causing maternal deaths is baseless because reports of women dying in labour at hospitals are a common place hence not of their (TBAs) own making.

“Traditional Birth Attendants are complementing the government efforts in assisting pregnant mothers to have safe deliveries,” he said.

District vice chairperson Mary Bebwajuba noted that a shortage of qualified staff coupled with lack of ambulances are the reasons behind the delay of referrals, leading to many deaths of expectant women in the area due to delayed birth.

Source: http://www.monitor.co.ug/News/National/Kabale+considers+law+to+force+pregnant+women+into+hospitals/-/688334/1463854/-/iox4poz/-/index.html

LOSING MY LIFE, TRYING TO GIVE LIFE IS NOT HOW I WANT TO GO

By Iryn

A lot of people keep asking me why I want to stay childless and of course, usually I just retort- ‘why not?’ but I’d like to tell everyone who cares to know that while death is inevitable; I don’t want to beg it to come to my doorstep and becoming pregnant lately will do just that. I have enough things bringing me closer to my Maker without having to add child bearing to the list; our life expectancy is at a mere 45years and I should be experiencing a midlife crisis anytime now, then there are those high risk transport things called boda bodas ridden by special men that try to see how far they can tease and coax death and get away with it every time I jump on one, and because of the high unemployment rate which stands at about 78% among youth, I just might die of starvation, desperation or depression- whichever gets me first.

But let me just walk you through the odds women have to go through in Uganda to give that life that so many people demand of them

On average, an estimated 16 pregnant women die every day in Uganda- that’s a lot of pregnant women if you ask me especially given that these deaths are preventable. I read and hear so many stories of women dying in the ward because of complications giving birth and my resolve not to get pregnant just becomes stronger and stronger.

There is the story of Jennifer Anguko who bled to death in a government hospital in October 2010, while waiting to deliver her child as her husband begged health workers for attention. Another lady recently is reported to have lost one of her twins while giving birth in IHK, a respected private hospital in Kampala and when asked what caused the death, the doctors actually dint know so it’s not just a public institutions problem.

I was also shocked to learn that for every woman or girl who dies as a result of pregnancy-related causes, between 20 and 30 more who survive will develop short- and long-term disabilities, such as obstetric fistula, a ruptured uterus, or pelvic inflammatory disease.

But more saddening is the fact that with Uganda’s fertility rate at 6.9%, and with your average Ugandan woman getting married at 18yrs, the number of women getting pregnant is not about to reduce.

Lately also, there have been more women that have pregnancy complications and need caesarian help to produce their child but there are only 200 surgeons out of the 2,105 registered doctors in the country. This means there is only one surgeon for every 400,000 Ugandans. And this morning I was reading an article in the New Vision about how unqualified doctors are operating on patients, case in point being the ongoing case against one Dr. Ssali of the Fertility hospital in Bukoto who admitted the doctor he allowed to operate on a female patient that passed away did not have a practicing certificate in Uganda.

Government hasn’t really done anything to change these statistics; in fact our health care system is falling apart if you ask me. CEHURD, an NGO, brought a petition against government complaining that it violated the women’s rights by neglecting to put essential medical commodities in place for them when they are pregnant and the Constitutional Court threw the case out holding that it could not interfere with the Executive’s mandate- I know, real jokers!

And so tell me reader, why in God’s name with all those odds against pregnant women, would I want to conceive on a whim of faith that at the end of those 9 months, I’ll be sitting on a hospital holding a bouncing baby girl?

I prefer to meet my death in another way, thank you

Source: http://rizzysdiary.wordpress.com/2012/07/04/losing-my-life-trying-to-give-life-is-not-how-i-want-to-go/

Are Ugandan Women Being Denied their “Rights” to Maternal Healthcare Services?

By Mark Omara

“If government cannot protect the welfare of women, as it relates to the delivery of adequate maternal healthcare, then it is indeed a sad day in Uganda.”

SOROTI, Uganda: Women wait at a maternity ward at Soroti Hospital for a midwife to attend to them. Uganda’s maternal deaths per 100,000 liver births are one of the highest in the world. CREDITS: guardian.co.uk

This question is a legitimate and an important question, particularly in light of recent astonishing developments with regards to issues of maternal and child healthcare in Uganda. Three stunning stories will elucidate the prevalence and magnitude of this monumental healthcare issue.

On Monday, July 9, 2012, Hajara Katusabe, a 24-year old expectant mother in Kibaale District was rushed to Isunga Health Center III in the wee hours as relatives frantically sought help from a resident midwife. Their arrival at the compound of the health center went unanswered as the midwife allegedly defied repeated pleas to arise and help the woman in labor, claiming fatigue from a heavy workload the previous day. Ms Katusabe eventually died as she fidgeted to give birth on her own, a sad development that drew the ire of local residents who turned out in droves with the intent to deliver a swift justice to an apparent “soporific, heartless and inept midwife.”

In December 2010, Jennifer Anguko slowly bled to death right in the ward of Arua Hospital. During the 12 hours of incessant bleeding due to complications of childbirth, not one doctor or nurse attended to her. Her husband, Valente Inziku, frantically changed her blood-soaked bed clothes as her life seeped away. “From the time when she arrived at the hospital at 9 a.m. up to the time when she died, she was not even asked anything by one of the nurses or any medical personnel. The nurses were just passing by,” said Anguko’s husband Valente Inziku.

The deaths of Ms. Anguko and another woman, Sylvia Nalubowa, were the catalyst for a lawsuit that was filed in March by the Center for Health, Human Rights and Development (CEHURD), a Ugandan nonprofit group. The landmark lawsuit contended that the Ugandan government violated the two women’s rights to life by failing to provide them with basic maternal care, and sought a declaration from the Constitutional Court to that end.

Ms.Nalubowa’s ordeal in a decrepit Mityana Hospital is particularly illuminating as nurses reportedly demanded a bribe of about Ush60,000 ($24) to buy airtime for a cellphone call to the doctor. Unable to pay the bribe, Ms. Nalubowa was taken to the maternity ward and left unattended, where she bled to death.

Following the lawsuit filed against the government of Uganda for alleged denial of women’s rights to maternal care, the attorney general’s office replied that the “isolated” acts cited in the case “cannot be used to dim the untiring efforts in the Health Sector.” The Constitutional Court eventually threw out the case on June 5, 2012, arguing that upholding the petition would have forced judges to wade into a political issue that was outside their jurisdiction. The petition’s supporters plan to appeal.

Are Ms. Katusabe’s, Ms. Anguko’s and Ms. Nalubowa’s deaths just outliers in an otherwise robust maternal healthcare in Uganda, or are these two experiences indicative of the average Ugandan’s experience as concerns maternal healthcare? It will be informative to take a look at the facts.

Maternal Healthcare Challenges in Uganda

There is a severe shortage of trained midwives and other health workers countrywide (14 health workers per 10,000 people, substantially lower than the WHO recommended number of 23 per 10,000). At most regional hospitals, almost half the positions for doctors are vacant, representative of a shortfall of 25,000 staff. Such extremely low patient-doctor ratios ensure that the physicians on duty will have to work several long hours in a day to meet the demand for healthcare services. One midwife reportedly worked alone and on-call for five months without a break. Under such enormous workload, the consequential midwife’s fatigue, for example, could drive noticeable tardiness in delivering patient care services, further making the healthcare experience deplorable for everyone.

A majority of clinics and hospitals regularly runs out of essential medicines, while only a third of facilities delivering babies are equipped with basics like scissors, cord clamps, and disinfectants, according to a 2010 Ministry of Health Report. Just 1 in 20 facilities has a vacuum extractor for assisted vaginal delivery, whereas a slightly higher number of 1 in 10 facilities have a dilation and curettage kit which is particularly essential for removing a retained placenta.

The quality of maternal services in the 12 regional referral hospitals have not kept pace with the increasingly swelling Ugandan population, putting significant strains on essential hospital supplies, facilities and staff. One regional referral hospital typically handles obstetric emergencies for about 3 million people, but some, like Arua Hospital, routinely runs out of sutures to sew up women after Caesarean sections.

In addition, according to a 2010 World Bank Report on the health services indicators in Uganda, the number of hospital beds per 1,000 population has plunged from a high of 1.65 in January 1976 to 0.39 in January 2008. It is not uncommon to see expectant mothers lying on mats in major hospital verandas while in labor, or overly crowded hospital wards that is indicative of the surge in the number of poor people seeking free medical help. The United Nations estimates that Uganda’s population will almost triple to 94 million, with tens of millions more babies to be delivered. It remains to be seen if any substantial effort will be dedicated toward ascertaining a commensurate improvement in maternal healthcare.

AMURIA, Uganda: A woman bathes her little boy in the female ward of Amuria Hospital. As Uganda’s population rockets, there will be a need for a commensurate improvement in maternal and child healthcare service delivery nationwide. This picture also illustrates the dilapidated facilities (such as beds, bathrooms, etc) in most of Uganda’s hospitals. CREDITS: jakelyell.com

Rampant electricity blackouts continue to jeopardize critical life-saving procedures to help expectant mothers in major hospitals. Indiscriminate load shedding that are routinely carried out by Umeme, the major power company in Uganda, to purportedly save money from high energy use, undermine patient health outcomes in several affected hospitals. Even worse, just a paltry 1 in 4 health facilities countrywide has electricity or backup generators with adequate fuel routinely available during service hours, according to a Ministry of Health report.

Such a dismal infrastructure record was recently lambasted by Primah Kwagala, a lawyer for the Center for Health, Human Rights and Development when CEHURD filed a complaint against Umeme: “How honestly do you expect a worker to perform C-Sections on a mother who is suffering obstructed labor if there is no electricity to sterilize instruments, or even light to see if it is in the night,” asks Kwagala. In Jinja Referral Hospital, it was reported that over 150 patients had died in a space of months due to an unreliable power supply and load shedding.

An important question to ask is this: “Why is Umeme routinely cutting off power supply to hospitals? When a patient dies as a result of an intentional power blackout, who owns the responsibility for his death?” CEHURD deserves credit for highlighting this important issue that not only affects expectant mothers, but all patients countrywide.

It is also interesting to look at the annual earnings of health workers in Uganda, and how that plays out in the debate concerning maternal healthcare in Uganda. In the 2009/10 financial year, the monthly salary of a newly recruited medical officer stood at about Ush650,000 ($265) and the starting salary of a senior doctor at around Ush840,000 (or $342); the entry level salary for a registered nurse was about Ush354,000 ($145). The take-home pay for nurses and midwives was reportedly as little as Ush120,000 ($50).

This dismal salary structure—the lowest for any particular professional level in East Africa—hardly incentivizes medical personnel in Uganda, and is squarely responsible for an increasing exodus of skilled medical personnel out of the country “in search for greener pastures.” Ugandan medical personnel have used words like “inadequate, deplorable, unfair, and poor” to describe how they feel about their remuneration packages. As it is, a significant fraction of medical personnel winds up working two or three jobs just to make ends meet, with government employees also working in private clinics/hospitals.

An unfortunate consequence of this practice is the alleged disappearance of essential medicines and supplies from public hospitals that are ostensibly sold to private clinics and hospitals. Further, health worker’s fatigue resulting from moonlighting is responsible for several bad practices that include alleged rude behaviors towards patients and unexplained absences. In spite of this practice of moonlighting, there is an apparent insatiable desire to bribe patients who want a quicker access to healthcare, a practice that is prevalent in several hospitals, particularly in the countryside.

Another important figure of merit to look at is the out-of-pocket health expenditure, the percentage of private expenditure on health in Uganda. This expenditure includes any direct outlay by households, such as gratuities and in-kind payments, to health practitioners and supplies of pharmaceuticals, therapeutic appliances, and other goods and services whose primary intent is to contribute to the restoration or enhancement of the health status of individuals or population groups.

Figure 1. This chart shows the out-of-pocket expenditures on health by individual Ugandans from 2000 through 2010. In recent years, Ugandans have had to spend more on healthcare, while government spending has stagnated at around 10% of national budget. SOURCE: WHO data

As Figure 1 shows, the percentage of individual Ugandans spending money out of their own pockets on health services dropped slightly from about 57% to 52% in the years 2000 to 2003, coinciding with the government’s decision to abolish patient fees in major hospitals at the turn of the millennium. Although the decision to abolish patient fees resulted into an increasing influx of poor patients seeking free access to healthcare, the out-of-pocket expenditures on health ticked up shortly after, reaching an astronomical high of 65% in 2006, and has remained steady at that rate since.

The immediate implications of this are clear: maternal mothers have got to spend huge sums of cash on stocking own supplies that hospitals routinely, inevitably runs out of—latex gloves, scissors, cotton wool, razor blades, antibiotics, etc. Thus, considering that about 35% of Ugandans live on less than $1.25 a day, it becomes incredibly difficult, if not downright impossible, for a mother with four kids in the countryside to stock up such expensive items in preparation for an impending childbirth. Add to this the unreliability and ineptitude of hospital services and you have a perfect formula for potential disaster at childbirth.

Maternal Mortality Ratio (MMR) in Uganda

The fifth millennium development goal (MDG) aims to improve maternal health, with the target of reducing the maternal mortality ratio (MMR) by 75% between 1990 and 2015. MMR represents the number of maternal deaths in a given period per 100,000 live births during the same period. According to WHO estimates, 10 countries have already achieved MDG 5, with reduction in mortality rates that fell between 76% (Viet Nam) and 95% (Estonia) by 2010. The WHO categorizes a high MMR as that which exceeds 300 deaths per 100,000 live births.

As might be expected, Sub-Saharan Africa had the highest MMR at 500 maternal deaths per 100,000 live births in 2010, while Eastern Asia had the lowest among MDG developing regions, at 37 maternal deaths per 100,000 live births. Chad and Somalia had extremely high MMRs (>1,000 maternal deaths per 100,000 live births) at 1,100 and 1,000, respectively. Uganda’s MMR stood at 310, with the lower and upper ends of the estimate at 200 and 500, respectively.

In 2010, 85% of the global burden of maternal deaths was borne by countries in Sub-Saharan Africa (56%) and Southern Asia (29%). Uganda was among those countries. About 5,200 women died from pregnancy-related causes in 2008, according to a recent University of Washington’s Institute for Health Metrics and Evaluation (IHME) study.
Figure 2. This chart shows the trends in maternal mortality ratios (maternal deaths per 100,000 live births) for the three East African countries from 1990 through 2010. For all three countries, MMR remain high at >300 maternal deaths per 100,000 live births.

Figure 2 shows the trends in estimates of maternal mortality ratios (MMR) by 5-year intervals, between 1990 and 2010, for the three East African countries: Uganda, Kenya and Tanzania. Among the three countries, Kenya is categorized as “making insufficient progress” towards achieving MDG 5; both Uganda and Tanzania are “making progress.” It is important to point out that all three countries had MMRs that exceeded 300, as of 2010. Some experts have put Uganda’s 2012 MMR at 450, suggesting that maternal mortality remains a persistent problem that needs an urgent redress. With the exploding population growth in Uganda, more women are at a significant risk of maternal deaths if current trends in maternal healthcare service delivery continue.

Is Government Spending Enough on Healthcare in Uganda?

All these grim statistics and facts bring into question what actions, if any, the government of Uganda has been engaged in to ameliorate a situation that has obviously gone awry. One of the complaints lodged against the government when CEHURD filed a lawsuit for alleged denial of women’s rights to maternal healthcare was that government was spending way less than what it promised to spend on maternal healthcare.

As experts see it, it is not like Uganda does not have sufficient funding and resources to tackle issues of maternal health. Since 2000, Uganda’s Health Sector Strategic plan has benefitted from direct donor support, accounting for 40% of Uganda’s health sector resources. The United States, for example, has donated $400 million annually as funding for the health sector.

But there has not been any increase in terms of the health sector’s proportional share within the annual budget, which has stagnated at about 10%. Moreover, in order to deliver the minimum healthcare package, the health sector needs an estimated $40 (Ush100,000) per capita per annum, according to experts. In the 2008/2009 financial year, the total public allocation to health per capita was a dismal $10.40 (Ush26,000), which is largely insufficient to meet population’s needs.

FIRED UP: Ugandan women activists carry signs outside the Constitutional Court building in May 2012, protesting the delay of a ruling in a landmark lawsuit regarding two women who bled to death while giving birth in Ugandan hospitals. The petitioners argue that by not providing essential medical commodities and health services to pregnant women, the government is violating the constitutional rights of Ugandans. CREDITS: The Associated Press in Kampala

The inadequate investment in maternal health has recently been described as contributing to an annual loss of about $112 million (or Ush275 billion), according to the United Nations Population Fund. Government has also tarnished its own reputation when it comes to public money as it has been plagued with a web of problems that include corruption and mismanagement of public funds, insensitive and wasteful spending on “trifles” such as the $700 million spent to acquire Russian-made fighter jets and military hardware in peacetime (last year), and the notorious entitlement spending on government ministers and members of Parliament.

Clearly, Uganda’s spending on maternal healthcare and healthcare in general is sorely insufficient, and is responsible, to a large degree, for the myriad problems that have plagued the nation’s healthcare sector. The government continue to pay lip service to propping up the nation’s healthcare funding, and as a result, more lives are lost daily because of poor healthcare.

The constitution of Uganda does not recognize explicitly maternal healthcare as a women’s rights issue. Chapter 4, Section 33, Subsection (2) of the Constitution states that “The state shall provide the facilities and opportunities necessary to enhance the welfare of women to enable them to realize their full potential and advancement.” If government cannot protect the welfare of women, as it relates to the delivery of adequate maternal healthcare, then it is indeed a sad day in Uganda.

Source: http://spookynewsug.com/tag/cehurd/

Medicines Patent Pool Side Event at the International AIDS Conference on Ways to Increase Access to Medicines

JULY 27, 2012 BY MIKE PALMEDO LEAVE A COMMENT
This blog is a summary of a July 25 satellite event at the XIX International AIDS Conference titled “The Future of Affordable Antiretroviral Treatment: Trends in Patents and Price.” The event was hosted by the Medicines Patent Pool (MPP). Powerpoint slides are online at http://pag.aids2012.org/session.aspx?s=319

Pedro Esgueira from the International Dispensary Association (IDA) foundation presented “Intellectual property-related challenges in the procurement of antiretrovirals: the perspective of a procurement agency.” His agency provides essential medicines to 160 million people, and regularly faces obstacles to antiretroviral delivery due to intellectual property rights. These include:

Seizures by customs officials, including those in the Netherlands, Estonia, and the Ukraine. As a result, IDA has had to reroute some of their medicines through less efficient transit hubs.

Limited sources of needed medicines. IPRs can block new entrants to the markets, even when there are bilateral voluntary licenses for generic production.

Lack of clarity regarding patent status and/or licensing status. For example, only one generic firm in Azerbaijan had a license to supply TDF+FTC, and it was unsure what the terms of the license permitted it to do.

High prices due to monopoly or restricted competition. This often puts patients on hold and makes second or third line drugs out of reach.

General delays and transactions costs. If there is a delay, IDA may be forced to go to the branded supplier, and the price can be significantly higher.

Political pressures that keep recipient countries from using TRIPS flexibilities, which forces IDA to purchase more expensive branded products. For example, El Salvador chose not to issue a compulsory license for political reasons.

Esgueira said that what has helped IDA deal with these obstacles is the use of TRIPS flexibilities; the MPP database and its voluntary license with Gilead; and WHO prequalification of medicines. His recommendation for overcoming the obstacles faced by IDA are:

Greater transparency of patent status and license terms in freely accessible public databases

Patent owner responsibility to disclose relevant information

More workshops on IP and the use of TRIPS flexibilities

Continued debate on redesigning the current research and development / IPR regime
More licensing to the MPP.

Gracia Violeta Ross Quiroga presented “Intellectual property-related challenges: a Latin American perspective.” Most countries in Latin America are categorized as middle income, so they are not a priority in global policymaking. There have been some countries that have done a great job in providing access to treatment, but the successes of some mask failures of others.

Concerns for treatment access in Latin America include:
High income inequality

Increased need for second and third line treatment due to first line treatment failure
High level of patenting of ARVs in the region

The patent situation is the worst in bigger countries with relatively high incomes that are considered to be potential markets for the branded firms. People living with HIV/AIDS often still lack the resources to buy medicines in countries where macroeconomic indicators rise.

ARVs are even patented in countries viewed as small markets (like Bolivia)
Many countries have already signed FTAs with TRIPS-Plus provision
Patents in India will also block access to antiretrovirals in Latin America that have Global Fund support

The Medicines Patent Pool is one mechanism (among others) that can help Latin America achieve universal access. However, it is a mechanism for bilateral licenses with pharmaceutical companies, and many company licensing policies do not include Latin American nations. It is important to address the terms of the licenses so that we can maximize the number of people who benefit.

Treatment advocates need to continue to work on intellectual property issues, as well as funding. Greater training on IPR and access to medicines is needed for people at the grassroots level.

Lihle Dlamini from the Treatment Action Campaign (TAC) presented “Mechanisms to address IP related challenges: the Experience of South Africa.”

TAC was born in December 1998 out of the need to supply antiretrovirals to people with HIV. At the time, a first line regime cost R75000 per patient per year (based on the average 1998 exchange rate, this is USD 13,656). Prices elsewhere had fallen, but South Africa couldn’t access the lower priced drugs due to patent issues. Early campaigns included mobilizing against a lawsuit by big pharma against a South African law that legalized parallel imports; the illegal importation of generic fluconazole from Thailand; and a 2003 competition law challenge against the prices of AZT and nevirapine.

TAC currently has a “Fix the Patent Law” campaign launched in 2007 to pressure the South African government to utilize all trips flexibilities. South Africa currently grants the highest number of pharmaceutical patents in comparison to other developing countries . These are often granted without proper examination. Researchers say that 80% of the patents issued in South Africa would not be granted if applications were examined. Therefore, the campaign is advocating for 1) stricter standards of patentability; 2) requiring proper patent examinations; and 3) establishing opposition procedures.

In 2012, TAC met with the Medicines Patent Pool to discuss disputes over the terms of the voluntary licenses reached with Gilead. Also discussed were concerns that the Pool was undermining efforts to achieve more fundamental changes to the global intellectual property regime through the greater use of TRIPS flexibilities.

Denis Broun from UNITAID discussed the issues that the organization considers when determining whether new generic firms can really enter the market and begin delivering medicines. The major problems faced by firms are access to raw materials (APIs); access to tech and know-how; the legal right to manufacture and get stuff on markets; and the ability to meet standards and to register their products.

Access to APIs. There are few firms that manufacture APIs, and generic firms can face patents or contract license issues. Companies with the exclusive APIs may end up using it to gain a competitive edge or to influence the market. For instance, nine years ago Abbotts’ price hike for ritonavir led to Kaletra dominating the market for ritonavir-boosted protease inhibitors.

Access to technology. The technology needed to manufacture medicines is protected by patents as well as by tacit knowledge. Licenses for the technology can come with a whole set of constraints related to its use. In some cases, you have situations where you could obtain a compulsory license, but lack the technology to bring the drug to the market.
Legal right to manufacture. Patents are still obstacles, and the patent landscape is changing. Many countries implemented TRIPS before they were required to do so, and it is among these countries that you find the most restrictive patent laws. Most new medicines now are patented in developing countries, and there are more patents per drug than there used to be. Patents are an even bigger problem for combination precuts, because the combination tends to be protected in more countries than the individual components. Other types of IP barriers to manufacture include data exclusivity and linkage.
Ability to meet standards and register. It is important that countries have fair and competent regulatory authorities. Many do not.

These types of obstacles are exacerbated by the trade agreements that are under negotiation. TRIPS flexibilities are important, and it is bad to undermine them.
Mariângela Simão from UNAIDS presented “Strategies for overcoming patent-related challenges in the generic industry: Different mechanisms to address intellectual property challenges.” She noted that treatment coverage has risen but we still have a long way to go, and that prices are still too high – especially for second line drugs. In some countries 25-30% of patients are already on second line. The vast majority of people with HIV/AIDS live in middle income countries, and the proportion is growing. However, many industry (and other) access policies are based on access for low income countries. A new approach is needed to ensure increased coverage for everyone, including those in upper-middle income countries.

There should also be no double standards regarding drugs prescribed in one region versus another. People in all regions benefit from drugs that are simpler to use and less toxic. Heat-stable drugs are good for patients no matter where they live.
UN agencies should continue to support countries on the use of TRIPS flexibilities and should continue to advise countries to avoid TRIPS-Plus measures in trade agreements.
Strategies for reducing costs of treatment include voluntary license mechanisms like the MPP, compulsory licenses, patent oppositions, and taking steps to avoid granting patents that shouldn’t be patented in the first place.

Chan Park of the Medicines Patent Pool presented “Addressing innovation and access though voluntary licensing: the MPP.” He noted that the patenting of antiretrovirals has increased in developing countries, and that newer drugs are more widely patented. This is true for first and second (and third) line drugs. There are also more follow-on patents. When you consider both the original and follow on patents on important medicines, patent expiry can be 10-15 years away.

The situation is more complicated when you get into fixed dose combinations (FDCs), where a patent on one component can block the whole product. The Patent Pool has found patent barriers on nine of eleven WHO-recommended FDCs, and all seven FDCs under development face patent barriers.

Mechanisms that can overcome patent barriers include taking full advantage of TRIPS flexibilities, as well as using voluntary licenses for generic production.
There are concerns that voluntary licenses are secret because only the basic features are disclosed. There are a wide range restrictions in the licenses that can negatively impact access. Licenses are often given to a few hand-picked manufacturers. There are no voluntary licenses on a number of products, and there are licenses with very restrictive terms on others.

The MPP currently has licenses with two patent holders and is in negotiations with four others. The core principles for MPP licenses are:

public health, pro-access perspective

reach as many people living with HIV as possible

terms and conditions should be consistent with TRIPS flexibilities

improve industry norms for voluntary licensing

manage licenses with a public health focus

work with partners to promote the development of needed formulations

The MPP aims to accelerate the availability of generic versions of new medicines, enable the development of FDCs, and enable the development of new formulations (i.e. – pediatric, heat-stable, etc.) It does sub-licensing work to ensure that the generic companies actually get drugs on the ground. It also provides a patent status database that includes data collected for 24 HIV compounds in 76 low and middle income countries.
Park listed the main achievements of the MPP:

Unprecedented publication of full text of licenses

Patent transparency on what HIV medicines are patented in which countries

Licenses from two patent holders and four more currently under negotiations

Higher standard on the number of countries covered by licenses (but there is still room for improvement)

Recognition of the importance of licensing medicines as early as possible (in pipeline)

Showing that voluntary licenses are TRIPS compliant

He listed the following as what still needs to be done:

obtain licenses from more patent holders

expand the number of countries benefiting from licenses

enable development of more FDCs and new formulations

enhance diversification of the manufacture of antiretrovirals

Source: http://infojustice.org/archives/26759

Intellectual property “still a threat,” to antiretroviral access, says panel

Mara Kardas-Nelson

Patents and intellectual property restrictions continue to affect acess to antiretroviral drugs, particularly in middle-income settings, according to research presented at the 19th International AIDS Conference (AIDS 2012) in Washington DC on July 25.

While generic competition has been essential to reducing the price of first-line ARVs, because of patent protection, the price of second- and third-line drugs have not seen a comparable drop. Presenting on a UNITAID-funded study on ARV price determinants, Jean-Paul Moatti said: “When activists say there is still a major problem for second- and third-line drugs, they are right.” Globally, first-line drugs are 65.3% cheaper than second-line drugs.

The price of branded second-line drugs has actually been increasing since 2008/2009, says Moatti, part of a general trend among pharmaceutical companies to increase the price of their product at the end of a patent life. While there is an average dip in price a few years into the 20-year period – due primarily to pressure from generic competitors – the price actually increases before the drug goes off patent, and increases even more after the patent has expired.

“When the patent is over, branded drugs don’t try to follow the generic companies and engage in competition,” said Moatti. Instead, in both developing and developed world markets, “they try to differentiate their product with packaging and so on”, keeping the price high.

Chan Park, the interim executive director of the Medicines Patents Pool, presented an analysis of current trends in voluntary licensing practices globally. Park noted that engaging in voluntary licenses was “hugely common throughout the industry”, with seven of the eight originator ARV companies signing such agreements. Yet, “there’s very little known about the various provisions that can be included in these licenses….there is wide variance within the industry,” he said.

Considering access to medicine, Park is specifically concerned about the number of licensed generic companies included in each agreement, and whether licensees can produce their own active pharmaceutical ingredients (APIs), and/or purchase APIs from other generic suppliers.

“Limiting the number of licensees may hinder the robust generic competition that can bring prices down,” Park said. “As a general rule, the more competitors there are, the lower the price of the ARV.” Given that the cost of APIs comprise a “significant proportion” of a final generic production cost, “there ought to be minimal restrictions on manufacture and sale of APIs by generic producers”.

Remarking on the methodology of the study, Chan noted that “a full evaluation of the terms and conditions was impossible as a result of the absence of transparency in voluntary licensing practice”, as the full terms of voluntary licence agreements are rarely made public. “Today, I call for increased transparency in voluntary licensing practices, and for companies to adopt access-maximising terms and conditions.”

Park also noted that while low-income countries are generally “well covered” in the scope of voluntary licences, “we still have a long way to go with covering upper-middle-income countries.”

Speaking on the panel, Kajal Bhardwaj of the Lawyers Collective noted that this was part of a trend by pharmaceutical companies to increasingly “cut out” middle-income countries from so-called “access policies”, in which pharmaceutical companies engage in voluntary licences and/or differential pricing, where lower-income and/or high burden countries pay less than their richer counterparts. This is despite the fact that, according to the Human Development Index, “more than half of the world’s poor actually live in middle-income countries,” said Bhardwaj, with huge economic discrepancies in places like India and South Africa.

As a result of the exclusion, Bhardwaj explained, middle-income countries have to “negotiate separately on a case-by-case basis with these companies, which makes it harder for them to get lower prices.”

While middle-income countries could utilise TRIPS flexibilities, specifically compulsory licences, many do not have the legislative framework to do so, and are being pressured by the world’s superpowers to ramp up intellectual property protection. (TRIPS – The Agreement on Trade-Related Aspects of Intellectual Property Rights – gives pharmaceutical companies the legal right to patent their drugs and applies to all the member states of the World Trade Organization.)

“What’s happening with the global aid and the global trade structure and how that shapes our countries’ decisions going forward should not be under-estimated,” said Bhardwaj. “The reality is that we’re actually going back on ten years of progress. The minute you have exclusions, you will be leaving many, many people out of treatment and access.”

But countries can flex their muscles. Francisco Viegas Neves da Silva of the Brazilian Ministry of Health spoke on the country’s compulsory licence for efavirenz. Initially granted in 2007 for a period of five-years, and recently renewed for another five, da Silva noted that the compulsory license – which allowed for local generic production of the drug while still under patent – significantly brought down the price of a 200mg tablet from $2544 per patient per year to $259 per patient per year (the current price is even lower at $107 per patient per year). Between 2007 and 2011 Brazil achieved savings of 58% in efavirenz drug costs as a consequence of compulsory licensing, da Silva explained.

“Increasing access is more important than economics,” said da Silva. “This is about how we can save money to put more patients on treatment.”

da Silva said that Brazil’s president, Dilma Roussef, would consider compulsory licences for more antiretrovirals and other drugs, such as for non-communicable diseases. He noted that simply having the threat of utilising a compulsory licence is an important tool in negotiations with pharmaceutical companies.

But according to Brazilian activists, the country can do more to promote access to medicines. Pedro Villardi of the Brazilian Interdisciplinary AIDS Association, or ABIA, presented the outcomes of a survey done by the Working Group on Intellectual Property to consider whether and how pharmaceutical patents were blocking access to medicine.

By conducting a thorough patent search on ARVs, the group found multiple patents on a single medicine, which could block access to generic versions. For example, while the patent for darunavir is meant to expire in 2017, a new patent filed could extend the patent to 2025. Villardi also noted that eleven drugs included in the survey were only supplied by one producer; lack of competition was keeping prices high.

Villardi said that increased transparency was essential. “The patent system is extremely non-transparent and patents are supposed to be public,” he said. “If you don’t know [about] the patent and the patent application…you can design neither public policies nor advocacy strategies to increase access to medicines, not just in Brazil, but in all of the global south.”

Villardi suggested that the country utilise the Bolar, or early working, provision; implement stricter patentability standards; and strengthen pre- and post-grant opposition mechanisms.

References

Viegas Neves da Silva F et al. Compulsory licence and access to medicines: economic savings of efavirenz in Brazil. 19th International AIDS Conference, abstract WEAE0102, Washington DC, 2012.

Park C et al. Understanding voluntary licensing: an analysis of current practices and key provisions in antiretroviral voluntary licenses.19th International AIDS Conference, abstract WEAE0103, Washington DC, 2012.

Villardi P. Panorama of the pharmaceutical patenting and sanitary registration of ARVs drugs in Brazil: implications to access and to health industrial complex. 19th International AIDS Conference, abstract WEAE0104, Washington DC, 2012.

Sagaon Teyssier L et al. Affordability of HIV/AIDS treatment in developing countries: an analysis of ARV drug price determinants. 19th International AIDS Conference, abstract WEAE0105, Washington DC, 2012.

Bhardwaj K et al. The ‘middle-income’ curse: should global aid and treatment access decisions be based on national economic criteria? 19th International AIDS Conference, abstract WEAE0106, Washington DC, 2012.

View information on the session, including links to the abstracts and slides from the presentations, on the conference website.

source: http://www.aidsmap.com/page/2453627/