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

Sisters in Death – Women in Kenya profiting from ARVs

In the video below NTV Kenya investigates a story of HIV+ women in various slums in Kenya who profit from ARVs given to them.

[youtube_video id=”xeiie4nusqA” width=”560″ height=”315″]

 

They are the people for whom free anti retroviral treatment was designed; HIV+ women do not have the money to access the medicine they need.  Yet for a group of HIV+ women in various informal settlements in Nairobi, the ARVs they receive do not profit their health, but they do profit from them.  Many unsuspecting Kenyans may be settling down to a drink that they’ve made, using the very same drugs that could save their lives. Here now is NTV’s Jane Ngoiri with a brand new NTV Investigates documentary, on women driven by poverty into a game of chance with their own lives, those of many others. These are the Sisters of Death.

Technology opens the doors of Africa’s health sector

By Fiona Graham
Technology of business reporter, Nairobi and Kampala

WATCH: In Kenya, only the very richest are guaranteed quality healthcare. The BBC’s Fiona Graham looks at the technology that could change that
“I had just attended too many funerals, people dying from completely preventable causes and treatable diseases.

“Standing at the sides of the graves and holding the babies of parents who had died from basic infections that are treatable in other parts of the world.” Stephanie Koczela is one of the founders of Penda Health, and she’s explaining what motivated her and her colleagues to open their first clinic in the town of Kitengela.

It’s a huge, sprawling, dusty conurbation that’s growing explosively, absorbing the overflow of people from nearby Nairobi.

A trip to the doctor’s in much of East Africa can be something of a game of Russian roulette.

As co-founder Beatrice Ongoce puts it: “In Kenya, healthcare quality is associated with being rich, being able to pay more, and bad options are related to being poor.”

Stephanie Koczela and Beatrice Ongoce at the Penda Health Clinic
The start-up aims to provide quality, affordable healthcare for the middle and lower income segments of Kenyan society. And to do this technology plays a big part.

“The surprising thing is that middle 70%, they spend about $1bn a year on outpatient healthcare alone in Kenya,” according to the third part of the team, Nicholas Sowden.

Lock, stock
This means there’s plenty of incentive to find ways to cut costs while keeping standards high.

“I think that most of the health care providers that we’re competing with don’t use technology at all to supplement their systems,” says Ms Koczela.

“They’re all paper records, their drugs are often out of stock.

Kitengela lies next to the Nairobi National Park, and is growing fast, as its neighbour Nairobi continues to expand
“We have a system that gives us a warning if any of our drugs are expired, and it forces our providers to dispose of those drugs immediately.”

Penda Health’s system is bespoke, tracking stock and expiry dates through a simple interface accessible from a PC. When supplies run low, this triggers a warning to make sure more is ordered.

“It raises our medical quality. One of the most common problems with healthcare providers in Kenya is that they don’t have the equipment that’s necessary to provide medical care.

The start-up had originally focused on women’s healthcare, including family planning and reproductive health, but soon realised that to attract women you need to treat the whole family
“This system ensures that we will always have what’s necessary for our patients.”

The clinic uses mobile broadband, meaning the system is completely portable – and mobile technology is useful in other ways.

Staff text patients to make sure they’re taking their drugs at the right times and in the right way, or to tell groups of patients that a specialist is visiting. Investing in an internet connection means accessing online resources to build up-to-date treatment protocols is fairly straightforward.

The start-up is now working on developing their own electronic medical records system – that ultimately will allow them to share those records if need be with specialists both within Kenya and internationally.

“We want to be the most friendly and highest quality provider for the low and middle-income Kenyan, and in order to do that we need to have tech systems that are backing our chain,” says Ms Koczela.

Right of way
For some Kenyans even the most basic clinic can seem out of reach. For many people living in rural areas, the nearest hospital could be many days’ journey away. Living in a rural area can mean that a trip to a doctor could take days. If you need to see a specialist, this means a referral, another long journey and probably a lengthy wait.

So to tackle this Amref – the African Medical and Research Foundation – is using computers and the internet to let local healthcare professionals consult urban experts.

The next step is to build an online knowledge base, says Amref’s Frank Odhiambo
“This technology is important because it helps cover the great distance that the poor have to cover while seeking healthcare,” says Frank Odhiambo, Amref’s telemedicine project officer.

The telemedicine equipment – computers, printers, scanners, and digital cameras – is provided by Computer Aid International.

The technology has been installed in around 50 hospitals in Kenya, as well as in Ethiopia, Tanzania, and Uganda, with more planned.

Operating in rural areas means connectivity is one of the project’s biggest challenges.

Although fibre-optic cable is gradually being rolled out through the region, large areas are still reliant on 2G mobile broadband, and even satellite broadband, which is pricey.

The telemedicine technology lets rural doctors share pictures and x-rays with specialists to find the right diagnosis. A reliable electricity supply is the other conundrum in rural areas. So Computer Aid is supplying Amref with solar-powered Zuba boxes – shipping containers fitted out as cyber cafes.

For Mr Odhiambo, the rewards of the project are clear.

“What I find most rewarding is availing a solution to someone in the most remote location, who does not have hope. IT just does it like magic.”

Beat of your heart
The mobile phone in your pocket can also prove an effective way to give people in isolated areas access to healthcare technology.

“Africa has a high mobile penetration rate,” says Aaron Tsushabe, an app developer with Uganda start-up ThinVoid.

The team behind WinSenga got the idea for the app after watching a nurse using a pinard horn . “They actually say that in about three years’ time there will be more phones in Africa than in the US.”

Mr Tsushabe and his team – all students at Makere University in Kampala – have developed an app that matches smartphone technology with the pinard horn, which has been in use for over 100 years to monitor the heart rate of unborn babies.

Joseph Kaizzi and Aaron Tsushabe have renamed the adapted pinard horn the senga horn
It resembles an old-fashioned ear horn, and is used by placing the wide end of the cone on the abdomen of a pregnant woman, and listening.

You then count the beats to calculate the fetal heartrate – one of the primary indicators of the health of the child.

This simple piece of technology is still widely used in developing countries.

The students took the pinard horn, and fitted it with a microphone, which plugs into the phone. The app monitors the sound of the baby’s heart, and can then indicate if there is any cause for concern.

The team recently took part in Microsoft’s Imagine Cup, the student technology competition, placing in the top 20 globally.

WinSenga is still in the prototype stage, although ThinVoid’s Joseph Kaizzi says they hope that it will be available generally very soon.

WinSenga takes smartphone technology and matches it with a pinard horn, a device invented in the 19th century by a French obstetrician, Dr Adolphe Pinard
“We’re working hard with the consultant from Unicef trying to make this as adaptable as possible, and we’re trying to localise it.

“It’s currently in English, we’re trying to get it in some of our local dialects.”

Dr Felix Olale is executive chairman at investment banking firm Excelsior Firm, based in Nairobi. He is also an adviser to the Kenyan government.

He says the future for healthcare in the regions depends heavily on investment in technology innovation.

“Ultimately it’s about patients and outcomes.

“It’s about increasing access to care for these folks who may not have access to facilities. It’s about increasing the socio-economic growth of these communities. Technology allows you to do all these things, right?

Dr Felix Olale: The future for healthcare in rural areas depends on investment in technology
“If we can take technology and build off of the infrastructure that’s already in place, what that does, it allows us to push these at a low investment for the amount of return that you actually get.”

In Kitengela, Penda Health has taken its reliance on technology one step further, issuing what they call “social shares” to fund their first clinic.

They used social media platform Facebook to find investors prepared to lend them the money to pay for the bricks, mortar and equipment needed.

They have big ambitions – and those ambitions rely heavily on technology to push growth.

“Technology allows us to have quality healthcare at scale,” says Penda Health’s Stephanie Koczela.

“With one clinic you could imagine we could monitor our drug supplies and do chart review with paper and all those things.

“But with a hundred clinics that’s just not possible. The only way to do that is to leverage amazing systems.”

Source: http://www.bbc.co.uk/news/business-18969646

Uganda needs 3,000 surgeons

By Francis Kagolo

http://www.newvision.co.ug/news/631729-uganda-needs-3-000-surgeons.html

The high rate of brain drain is continuing to wound Uganda’s health sector with fresh revelations indicating the country is short of over 3,300 surgeons.

An expert said many people who would have survived treatable surgical conditions like cataract blindness, hernia, clubfoot and injuries end up dying due to inadequacy of surgeons in the country.

“Every year, Makerere University, other institutions and hospitals pass out surgeons. But due to low pay, many quit the country for greener pastures abroad,” said Dr. Edward Naddumba, the secretary general of the College of Surgeons of East, Central and Southern Africa (COSECSA).

“Currently we are less than 100 specialist surgeons for 34 million people. This means one surgeon for every 340,000 people.”

Other potentially productive people become disabled and destitute because of treatable surgical conditions, he said.

Naddumba made the remarks while briefing New Vision online on COSECSA’s efforts to improve the numbers and working conditions of surgeons in sub-Saharan Africa.

The efforts include offering specialized postgraduate surgical training at major hospitals like Mulago, Nsambya and Masaka.

The college passed out four graduates at its first graduation ceremony in 2004. About 113 trainee surgeons are to sit the COSECSA exams this year, 51 of whom are in their final year.

The college charges $1700 (about sh4.2m) as entry, examinations and graduation fees.

His revelations come amidst a public outcry over the underfunding of the health sector.

A report by Makerere University Medical School two years ago revealed that health spending in Uganda covers about a third of what the country needs to meet its minimum healthcare package.

It said Uganda spends only $14 per-capita on health. Of this, $9 is out-of-pocket and $5 from public sector (government and donor funding).

Today, less than 100 specialist surgeons available for 34 million Ugandans.

Yet, as the country’s health system remains in a coma, the Government still spends at least $150m (about sh368b) annually treating top government officials abroad.

This amount is nearly half of the combined budgets of health and education ministries.

Makerere’s development expert Prof. Augustus Nuwagaba recently argued that Uganda’s problem is not lack of medical practitioners but poor remuneration.

“Almost half of the 40,000 Ugandan professionals in North America are health personnel, which means our problem is not the human resource,” he said.

Do We Really have Drug Shortage?

Analysis by Paul Abusharizi

Nalongo’s son had just under­gone an operation and it was long past the time he was supposed to get his final pain killer for the day. She looked on helplessly as he whimpered in pain as his father went in search of the doctor on duty.

The nurse on duty, when she came around three hours after the 6:00pm prescribed time for the young man’s doze, claimed the drugs were not in stock and that they should go outside the hospital to buy the drugs, which prescription she hastily scribbled on a piece of paper.

As it turns out the drug was very much in stock. For those in the know this was a subtle attempt by the nurse to extract some money from the parents of the in-pain boy.

All this happened at the national referral hospital — Mulago. While the end user is un­der the impression that our health centres are suffering a perennial drug shortage, National Medical Stores is sitting on tons of drugs which are reportedly in short supply.

“My warehouses are full of drugs to the point that I am asking my suppliers to hold with future deliveries as I try to work these ones out of the system,” NMS boss Moses Kamabare told Sunday Vision.

Clearly, between NMS warehouses and the end users, there is a bottle neck that is pre­venting the end users from accessing lifesaving drugs.

Three years ago in an attempt to alleviate the perennial drug shortages in public facili­ties, government centralised the procurement process under NMS.

Previously, the procurement of drugs was decentralised to the national referral hospitals ‑Mulago and Butabika, the regional referral hospitals and the districts, which supplied the health center II to IV.

By centralizing drug procurement govern­ment hoped to take advantage of the discounts possible with the ensuing economies of scale, create uniformity of supply and curb drug thefts.

Under the current system the referral hos­pitals and the districts provide NMS with a procurement plan, which guides NMS as to the drugs and their quantities to buy for the year as well as how regularly they should be dis­bursed. NMS only procures according to these plans.NMS has a delivery schedule which is monthly for Mulago and Butabika and once every two months for everybody else.

Since the capacity to quantify needs was lacking at the lower health centres the health ministry came up with a basic kit, which has most of the essential drugs and supplies like gloves, which are supplied to the health cen­tres two and three.

So NMS clients are supposed to requisition their drugs according to their pre-determined procurement plans and only then will they be supplied with the drugs.

“That is where the problem starts. We quick­ly found out that either they do not requisition, so we don’t dispatch or they requisition less than they already planned for leaving us with unused stock,” Kamabare said.

That is where the discrepancy between shortages at the health centres against the contradiction of NMS’ full warehouses begins.

By not requisitioning or under requisition­ing you have health centres without drugs for months or running out of supplies ahead if schedule respectively.

Why this happens is a mixed bag of motives that range from incomprehensible incompe­tence to sabotage of an innovation that would expose the old practitioners to individual abuse of the system to meet personal needs.

“For example some prescribers can prescribe medicines that are not on our national essen­tial medicines list. The idea being the patient would have to go out of the hospital to order the drugs living the impression that the hos­pital is short on drugs while the truth is that a perfectly adequate drug is readily available in the health facility’s dispensary,” Kamabare said.

Clearly a holistic solution to the prob­lem including increasing health workers pay and welfare and training many more health workers is required.

But as a start beyond the streamlining procurement Kamabare counsels the use of medicines only listed in the national Essential Medicines List and prescribe as stipulated in the Uganda Clinical Guide­lines – which has detailed descriptions of common ailments in the country and how they should be prescribed for.

“Artificial scarcities are being created and sustained contrary to the truth, “ the NMS boss says. “Among the drugs we are over laden with are those for cancer, TB, ARVs, family planning supplies, rabies vac­cines, insulin and mama kits.

My concern is not that my warehouses are full but what is happening to the rightful patients of these drugs …. Aren’t they dy­ing because of a failure of our systems?”

https://www.cehurd.org/2012/05/do-we-really-h…-drug-shortage