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.

Source:http://www.ip-watch.org/2012/01/28/who-board-plan-for-fake-medicines-mechanism-excludes-trade-and-ip/

Kaproron health centre a death trap

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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

www.newvision.co.ug/section/53-10-Health.html

Rwanda to buy Uganda’s drugs

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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

http://www.newvision.co.ug/news/628633-rwanda-to-buy-uganda-s-drugs.html

East African Community: Are we running fast yet standing still?

Presidents L-R; Museveni, Kagame, Kikwete,Kibaki and Nkurunziza after the adoption and signing of EAC Customs Union in Arusha in 2009.

By Sheila Naturinda

The just concluded East African Community summit in the Burundian capital Bujumbura, has revealed that the political leadership is more optimistic about the process than its citizens.

The summit also reveals that there is a lot of political will to see that the federation is achieved, come 2015. However, it yet again brought out the underlying challenges that the community is facing, further justifying the call from observers that the step toward forming one state should be greeted with “caution optimism.”

The optimism seems warranted because the EAC leaders have shown a consensus that trade and private sector investments are crucial inputs to sustained growth and development. But some caution regarding what to expect from the EAC is hardly surprising, as the collapse in 1977 of an earlier effort at regional integration, suggests that the road ahead is not straight forward, with numerous barriers left that must be overcome.

The EAC observers argue that factors that led to the collapse of the bloc in the 1970s are playing out differently at the moment and efforts to form a federation are being carried out under very different set of political and economic circumstances.

Catching up
They point out that the fast growth of Uganda and Tanzania in comparison to Kenya over the past 20 years, has not only narrowed the gap between them and their larger neighbour, but it has given these nations confidence in their competitive abilities.

On the political front, all three countries are much closer politically than they were 30 years ago. Changes in the economic structures of these countries and a growing middle class that has increasingly sophisticated product demands, suggest that the benefits from trade may be greater than earlier times when the commodity structures of all these countries were mainly agricultural.

“These three reasons may give us confidence that “This time is different when it comes to the gains that each country can capture from deeper regional integration,” Prof. Ethan Kapsteine, in a paper on the future of the integration, said.

While the observers say the integration this time is different, research shows that the citizens are skeptical and doubt that the changes are significant enough to give greater confidence that the East African integration will promote trade, investment and job creation in the years ahead.

Reports from experts hired to look into integration issues and the recommendations from the council of ministers that provide a road map for the way forward, have been largely adopted by political leaders.

The reports, however, show that citizens have a feeling that democratic deficits and lack of accountability that exists in some countries may be replicated at the regional level.
The fears and concerns registered by the populace were categorised into political, economic, legal and socio- cultural, among others.

From a political perspective, the East Africans are scared of losing their sovereignty. And since the 2015 political federation means creating one single state, it means partner states should prepare to cede some political powers.

On legal grounds, the people insist that there are many disparities in governance, probably the reason why Tanzania, the largest of all the states is taking a slow motion in signing most policies as developed by the states.

“I believe these are very pertinent issues and we should take them very seriously. When Burundi and Rwanda joined the community, there was a special programme for bringing them on board,” Ms Dora Byamukama, a Ugandan representative in East African Legislative Assembly, says.

Land wrangles
There is a fear that with the limited land in some states, some people may lose the little space they have. The fear to lose land therefore continues to be a sensitive issue and as the experts reported, “a potential source of conflict” when the countries finally federate.

Source: Daily Monitor

http://www.monitor.co.ug/SpecialReports/-/688342/688342/-/eduqir/-/index.html