Drugs cut cost, but highten the risks

By Shan Juan and Wang Qingyun (China Daily)

Poor cancer patients turning to Indian copies from illegal traders

BEIJING – When Zong Jiujin was diagnosed with leukemia in his senior year at college, his doctor told him only two things could save his life: a bone marrow transplant or Gleevec, an approved cancer drug.
Both are expensive options in China, far too costly for the son of poor farmers from East China’s Jiangsu province.

Yet, as he got up to leave the examination room, the doctor suggested another alternative: unapproved, “generic” cancer medication imported from India. The costs are low but the risks are high.
“My parents could never have afforded the other remedies, so I began to take the Indian drugs,” said Zong, who has been successfully battling his condition since December 2010.

Instead of spending 24,000 yuan ($3,800) a month on Gleevec (or Glivec in some parts of the world), the 24-year-old said he pays a black-market trader just 1,600 yuan for generic copies.

“Another patient introduced me (to an agent),” he explained. “We’ve never met, we just communicate over the phone. The drugs are mailed to my home.”

Although illegal, health experts say there is a huge demand for such services in China, particularly among cancer patients, who are increasing in number at a rapid rate.

Ministry of Health data released ahead of World Cancer Day on Saturday show that there are 2.8 million new cases reported nationwide every year, with the disease killing an annual average of 1.8 million people. Over the past three decades, the mortality rate among cancer patients has soared by 80 percent on the mainland.
“I’ve been consulted about India-made drugs quite a lot by patients,” said Zhu Guangying, a lung specialist and head of radiotherapy at Peking University Cancer Hospital. “I always recommend my patients stay away from them, as without scientific evaluation it is difficult to determine the effect.”
Demand and supply

The wide availability of India’s generic drugs stems largely from patent laws it introduced in 2005, which state that only new compounds developed after 1995 can be protected. This means that many products are recognized as new versions of old treatments.

Jia Ping, a Beijing lawyer who specializes in public health cases, explained that, without intellectual property rights protection, manufacturers of generic drugs can freely copy these medicines and slash the price, sometimes by as much as 90 percent.

Analysis by Medicins sans Frontieres, an international health organization, suggests India now makes one-fifth of the world’s generic drugs, with about 50 percent shipped abroad and sold (often illegally) at a fraction of the cost.

An online sales agent for Bao An Tang, which supplies generic drugs, said the most popular product among Chinese customers were copies of Gleevec, Iressa, Tarceva and Nexavar, which are all used to treat cancer.
“We’ve been doing business for three years,” said Lu, the agent, over the QQ messaging service. “It’s kind of special business, so we only mail drugs and never meet clients in person.”
Lu added that the company sells hundreds of units every month.

The people who market generic drugs in China claim the medication can have the same effect as the expensive originals. However, manufacturers of the approved drugs warn otherwise.

“A number of noted authorities, including the World Health Organization, estimate that drugs purchased on the Internet are more likely to be substandard or counterfeit products,” said Novartis, the Switzerland-based pharmaceuticals company that makes Gleevec, in an e-mail statement. “Counterfeit and poor quality drugs may contain impurities and metabolic products exceeding international standards, which may pose health issues for patients using these medicines.”

In 2010, authorities in Jiangsu’s Huai’an reported that a man diagnosed with lung cancer had suffered adverse reactions after taking an India-made generic copy of Iressa purchased online.

An investigation by the State watchdog found that the drug was produced by a US-trained biochemist identified only as Zhang.

To tackle the problem of illegally imported drugs, the State Council last year launched a special health campaign.

“It mainly aimed at Internet scams in which profiteers promoted and sold fake drugs or those sourced through illegal channels,” said Bian Zhenjia, deputy director of the State Food and Drug Administration, who added that medication designed for long-term use, such as treatments for impotence, diabetes, hypertension and cancer, are major targets for criminals.

In November, public security officials in Guangdong province seized almost 40,000 illegally imported anti-cancer tablets and capsules during a raid on premises being used by an online-drugs seller.

“Drugs were special commodity and should be given special attention in terms of intellectual property rights protection,” Bian said, referring to India’s patent laws.

With research and development on new drugs sometimes taking more than 10 years, patents should be secured, “otherwise counterfeit and substandard drugs will enter the market, threatening public health and delaying treatment”, he added.

Crackdown on crime

Like many people in his position, Zong Jiujin knows the risks of buying generic drugs on the Internet. However, he argues that the more the government cracks down on black-market traders, the fewer options poor people have.

Treatments like Gleevec, which typically cost upwards of 10,000 yuan a month, are not covered by the government-run medical insurance system on the mainland. However, official data shows the average salary of Chinese urbanites in 2011 was about 24,000 yuan, and far less for rural residents.

“If I had the money, I’d definitely buy the legal drug, as it’s more secure,” Zong said. “But (with the crack down) it’s almost like we are being deprived by the government of the right to affordable treatment. Poor patients have no other choice but to buy cheap drugs. If the government wants to crack down, it should at least give us more subsidies.”

Lung specialist Zhu agreed, and added that more local governments should follow the example of Guangdong province, which has started to cover the cost of Iressa for cancer patients who respond well to the medicine.
International watchdogs such as Medicins sans Frontieres say generic competition has dramatically reduced drug costs in some countries. For pharmaceuticals that treat AIDS and tuberculosis, countries such as Brazil, South Africa, India, and Thailand have introduced compulsory licensing systems for domestic drug suppliers, allowing them to better guarantee safety.

However, lawyer Jia Ping said he fears that the drugs market is not currently a priority for authorities in China.
“The decision-makers have varied opinions,” he said. “Some say China has become rich and can afford patent drugs, others say the country should depend on innovation and develop its own drug research.”

Although there is no legal barrier to such a system in China, “no domestic pharmaceutical company has so far applied for compulsory licensing of a foreign patent drug”, he said, adding that Chinese manufacturers had a “relatively poor understanding about World Trade Organization treaties and public health”.

Li Jiancheng, an attorney based in Shandong province, said that, under current law, compulsory licensing of drugs can only be granted in the event of a major public health crisis.

“Conditions like cancer hardly fit that category,” he said.
China Daily


WHO Board Plan For Fake Medicines Mechanism Excludes Trade And IP

By William New, Intellectual Property Watch

The World Health Organization Executive Board this week agreed to propose to the May World Health Assembly the establishment of a mechanism for international collaboration on counterfeit and substandard medical products, but with the exclusion of trade and intellectual property issues.

The Executive Board resolution would “establish a new Member State mechanism for international collaboration among Member States, from a public health perspective, excluding trade and intellectual property considerations, regarding “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” in accordance with the goals, objectives and terms of reference annexed to the present resolution.”

The next Assembly in May will decide on this resolution. The mechanism would be reviewed by the World Health Assembly after three years, and will submit a progress report after one year.

The Executive Board resolution on “substandard/spurious/falsely-labelled/falsified/counterfeit medical products,” EB130.R13, is available here [pdf].

Documents from 130th Executive Board meeting, held from 16-23 January, are available here.

The resolution as proposed by the board has only one modification from the earlier draft version from the Working Group of Member States on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, as established by decision WHA63(10) from 2010.

The draft version urged member states to: “participate in and collaborate with the Member State mechanism referred to in operative paragraph 4” (which establishes the new member state mechanism). The Board added at the start of the sentence, “on a voluntary basis.” This was suggested by China, according to participants.

Other elements of the resolution include a statement of the role of WHO in these issues, which is: “ensuring the quality, safety and efficacy of medical products; in promoting access to affordable, quality, safe and efficacious medicines; and in supporting national drug regulatory authorities in this area, in particular in developing countries and least-developed countries.”

It also declares that WHO should “continue to focus on and intensify its measures to make medical products more affordable, strengthening national regulatory authorities and health systems which includes national medicine policies, health risk management systems, sustainable financing, human resource development and reliable procurement and supply systems; and to enhance and support work on prequalification and promotion of generics, and efforts in rational selection and use of medical products. In each of these areas, WHO’s function should be: information sharing and awareness creation; norms and standards and technical assistance to countries on country situation assessment; national policy development; and capacity building, supporting product development and domestic production.”

And it calls on WHO to increase its efforts to support members in “strengthening national and regional regulatory infrastructure and capacity.”

A contentious issue around counterfeits has been the suspicion on the part of some developing countries that concerns about counterfeit and substandard medicines are being purposely confused with trade in legitimate generic medicines from those countries. Removing intellectual property and trade from WHO discussions likely minimises the possibility of confusion.

Participants said a lack of agreement persisted during the Executive Board meeting over definitions and the WHO’s involvement in the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

Meetings of the new mechanism would normally take place in Geneva, but could be held elsewhere. Argentina offered to host the first meeting after the WHA, according to participants. Regional groups will provide input as appropriate, according to the resolution.

The resolution also places the provision of financial resources on member states.

The report on the financial and administrative implications of this resolution, document EB130/122 Add.1, show that over three years (2012-2015) it would cost between US$ 3.56 million and US$4.84 million. This includes staff costs of $2.72- $4 million, and activities of $840,000. This would assume only one annual meeting of the mechanism. These costs were not within the approved 2012-2013 budget, and could not be implemented by existing staff. It would require two professional staff and one general services staff member.

For 2012-2013, funds of $2.37-$3.23 million would be needed from voluntary contributions from interested governments, as it may not fit with donors, the analysis said.


Kaproron health centre a death trap


Patients bask in the sun as they wait for doctors to attend to them.

By Frederick Womakuyu

Rose Chelangat, 24, had just delivered and had lost a lot of blood that she was bed-ridden. She could hardly stand up or speak. She urgently needed blood transfusion. Her newborn baby also needed some blood.

But Kaproron Health Centre IV — the only health facility in Kween district serving a population of about 205,000 people, did not have any. The newborn needed to be fixed on an oxygen concentrator  but the health facility did not have any.

Chelangat needed oxytocin to control bleeding but it was out of stock. Therefore, the health workers recommended that Chelangat and her baby be transferred to Kapchorwa Hospital, 40km from Kween.

But the health facility ambulance did not have fuel, so they asked her to pay for fuel. “But we did not have money, so we strapped her on a stretcher and rushed her to Kapchorwa Hospital,” explains Peter Chemisto, her husband.

However, halfway the journey, the mother died, leaving behind three children. The newborn baby was still alive but Chemisto did not have any more energy left to continue. Weeping, he decided to go home instead and by the time he reached, he had two dead bodies.

“I lost my child and the mother due to poor health services. A health facility is supposed to save lives but this one has become the leader in taking away lives,” says Chemisto.

Blood shortage

According to the in-charge, Boniface Muge, three newly born children die everyday because the facility has no blood transfusion services.

He adds that the facility also loses about two mothers every three months due to lack of blood.

In the maternity ward, there is nothing to write home about. While the three-bed labour suite glitters with new equipment including delivery kits and beds, there is no single doctor to operate on mothers who need a caesarean section yet the facility receives about 10 women per week that need one.

No wonder an average of 500 women in the district die of complications related to child birth annually, which is the second highest in Uganda, after Karamoja.

While the three enrolled midwives try as much as possible to help the mothers deliver properly, lack of an oxygen concentrator for the newborns to re-energise their breath and lack of oxytocin plugs the facility.

Like many rural facilities, this health centre also has no electricity yet a power line passes over their roof.

A huge generator that can power a full trading centre lies silent in the compound because they cannot afford fuel. Since they bought it, they have never used it due to lack of funds to get fuel to power it.

The health facility receives less than sh20m annually to carryout repairs and rehabilitation, fuel for vehicles and generator, administration and secretarial services. The facility uses charcoal to boil and sterilise delivery instruments. The fact is, Muge admits, most times the kits get contaminated, which affects the health of mothers.

While some mothers are able to deliver normally without any problems, they are told to buy everything including drugs, syringes, gloves and disinfectants like jik because the facility does not have them.

Jane Chebet, 34, a mother who had just delivered says she was asked to buy a syringe and the drugs at the nearest clinic which she suspects is owned by one of the health workers.

She was also asked to buy the gloves and Jik and all this cost her about sh30,000. At least she could afford it since her husband is a teacher. However, it took three days for her to finally get treatment.

“We buy everything here. The health workers tell us that they do not have what we need,” adds the mother five.

Death everyday

Despite having shiny new buildings, Kaproron health facility is known for having deaths almost every day. On the day New Vision visited the facility, all the drugs were out of stock and the few patients at the facility were advised to either buy some from the drug shops and clinics or go to Kapchorwa Hospital or simply go back home.

Alice Chelimo, 30, of Benet sub-county, had stayed for a week. Her son was suffering from severe malaria. The health facility did not have any antimalarial drugs to help him.

So, the health workers advised her to buy one from a clinic. She bought some at sh15,000 — the only money she has saved for close to a month and did not have anymore, yet by that time the boy had not yet recovered.

Severe staff shortages

Serving at a level of a hospital — this facility is supposed to have at least an X-ray or C-scan and several specialists. But the facility is serving at almost less than 10 percent health staffing professionals.

While they are supposed to have at least seven doctors, they have none. The only doctor at the district is the district health officer and due to his overwhelming duties, he rarely attends to the patients that need him.

The facility has no registered nurse except three enrolled nurses, yet these are supposed to be 25. The bottom line is that the health workers at Kaproron are some of the most overworked in the country. Some work for nearly 24 hours a day. No wonder many frustrated patients who cannot understand what goes on in there, are crying.

Boniface Muge explains that they want to recruit more staff but many people do not want to work there because the place is difficult to access with an impassable muddy road during the rainy season and poor pay.

According to Muge, while their counterparts in other districts like Bukwo are being paid a top up allowance of over 50% of what they earn, the health workers in Kaproron do not have any of this.

He, therefore, requests the ministry to pay them a hardship allowance to attract health workers there.

Amuru:Medics, patients abandon health centres

By Norman Katende

Staff and patients have abandoned over nine health centres in Amuru district due to the failure by the National Medical Stores (NMS) to supply them with drugs for over a year.

Among those health facilities abandoned is the sh120m Apaa Medical centre, which was constructed under the office of the Prime minister projects.

The centre, which has two houses, had a health assistant and three medical nurses to serve the population of Apaa and its neighbouring districts but after failing to get the drugs they entire team relocated to Pabo town.

The residents of the area have since then resorted to using traditional (herbal) medicines and self-medication.

“It was the nurses that first left after seeing that they had nothing to treat their patients with and also feared that the community might end up shifting blame on and attack them,” the LCIII chairman for Pabo county Christopher Ojera said.

“Most of them have resettled in Pabo to wait for the arrival of drugs. It is now over six months without getting drugs.”

He said that over eight health centres across the county have been forced to close.

“There are no drugs yet we have written letter to the district and National Medical stores with no results at all. We have also tried to request the area MPs and other politicians to try and meet these people to see that we at least get the basic drugs like for malaria and save the people from dying,” Ojera sounded disappointed.

He added that so many lives have been lost because of the long distance to other health units in the districts of Pabo, Gulu and Adjumani, also worsened by the poor state of the roads.

Source: New Vision


Rwanda to buy Uganda’s drugs

President Kagame examining drugs at Quality Chemicals in Kampala

By Conan Businge

President Paul Kagame has pledged that his Rwandan Governemnt will soon start buying some of its antiretroviral and anti-malarial drugs from Quality Chemicals in Uganda.

President Kagame made the pledge on his visit to Quality Chemicals factory in Kampala city’s suburb, Luzira, yesterday morning.

Quality Chemical’s chief executive officer, Emmanuel Katongole, in his brief to the press after the inspection of the factory on Friday, said President Kagame’s pledge will start with purchases for the public sector.

“We will also be selling to the private sector, on top of the public sector,” Katongole added. Katongole promised President Kagame drugs which meet the international standards.

“We shall offer you first-world quality of drugs, at third-world prices. Our prices are not the lowest, but are comparable to those recommended by World Health Organisation.” Quality Chemicals has already registered its products in Rwanda, and have a pre-qualification by WHO.

President Kagame also promised to work with Uganda, to locally process anti-malarial drugs’ raw materials- ‘Artemisia annua.’ Artemisia annua is the source of artemisinin, an antimalarial compound recommended by the World Health Organisation. Widely cultivated in China and Asia, Artemisia is a new crop for Africa and is largely limited to Kenya, Tanzania and Uganda.

Today, the harvested plants in Uganda are exported for processing in India, after which Quality Chemicals, like other pharmaceutical companies, buys it as a raw material to produce antimalarial drugs.

“With Rwanda opening up its market for our products, it will greatly resonate Quality Chemicals in the rest of Africa and spur more investments in the rest of Africa,” Katongole said.

Katongole added that Quality Chemicals is also considering investing in Rwanda.

Quality Chemical Industries is a state-of-the-art pharmaceutical manufacturing plant located in Kampala, Uganda.

It exists as an additional contract manufacturing site for CIPLA Ltd, which manufactures and sells combination therapy antiretroviral and antimalarial drugs that have proven to be most effective in combating HIV/AIDS and Malaria.

Source: New Vision