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WHO will set generics apart from counterfeits

By Vineeta Pandey

World Health Organisation (WHO) has adopted a resolution to clearly define counterfeit medical products (CMP) so as to set them apart from genuine generic drugs.

The resolution follows intense lobbying by India at the World Health Assembly (WHA) last week and is seen as a major diplomatic win. The country has worked through back-channel ways at the inter-governmental level for almost two years to pressurise the international organisation.

This also means WHO will limit its role to public health issues and not get into the debate of intellectual property rights (IPR) raised by multi-national companies to block generic drugs from India and other countries from getting into international markets.
Generic drug shipments from India have often been seized at European Union ports on charges of infringing IPR and therefore qualifying as counterfaeit or spurious products.

Sources said innovator pharma companies have used multiple routes, including raising IPR issue with WHO through its arm International Medical Products Anti-Counterfeiting Taskforce, to stop generic drug consignments from India.
In 2009, for instance, a Brazil-bound consignment from India was stopped at Amsterdam.

“The authorities applied definition of CMP for these generic drugs as the history of such drugs showed patents in EU. Hence, they termed it as infringement of their IPR and seized them,” said a Union health and family welfare ministry official.

Such seizures forced India and some other countries to aggressively take up the matter at WHA. Expressing concern over the involvement of WHO’s Western Pacific Regional Organisation in the enforcement activities relating to combating CMPs, India strongly argued that WHO was mixing up issues of public health and private IPR in the context of defining counterfeit drugs.

The Indian delegation, backed by Brazil, Thailand and other BRICS and SEARO nations, sought to limit WHO’s role only to public health and said it should concentrate on affordability and accessibility of drugs rather than be engaged in IPR enforcement issues.

WHO now appears to have put in place a new mechanism with the consensus of all member states to clearly define CMP as “substandard, spurious, falsely-labelled, falsified” drugs to bring uniformity for better global acceptance of these definitions without interrupting the supply of genuine generic medical products in the world.

India is now pressurising WHO to give more funds to strengthen the national regulatory authority for drugs.

Source: http://www.dnaindia.com/money/report_who-will-set-generics-apart-from-counterfeits_1697759

CONSTITUTIONAL PETITION NO. 16 RULING TO BE DELIVERED WITHIN 14 DAYS FROM TODAY (25TH MAY 2012)

By Racheal Aduk (rachealaduk@gmail.com)

Today the Registrar for Constitutional Court, His Worship Erias Kisawuzi promised to deliver the ruling on the maternal health petition before a delegation of civil society advocates who are fighting maternal mortality in Uganda.

Nakibuuka Noor From CEHURD listening to the Registrar as he responds to the CSO complaint

“The maximum days of delivering this ruling will be 14 days from Today. It can be less, it could even be ready by next week” His worship Erias Kisawuzi Said.

This announcement follows a march to Constitutional Court organized by the Coalition to Stop Maternal Mortality in Uganda on Tuesday May 22. The protesters, including more than 150 activists, grassroots home based care providers, and community leaders, were objecting to a 7-month delay by the Constitutional Court.  Mr. Kisawuzi apologized to the protesters on Tuesday for the delay by Court to deliver the ruling (see: “Judiciary Apologizes over Delayed Maternal Health Ruling,” Daily Monitor 23 May 2012).

“The Court is finally responding to concerned citizens,” said Nakibuuka Noor Musisi of CEHURD. “We appreciate that. Maternal mortality is a crisis in this country, and Court has the power to change this crisis”

Constitutional Petition No.16 of 2011 argues that by not providing essential medical commodities and health services to pregnant women, the government is violating the Constitutional rights of Ugandans. The Petition highlights the cases of Sylvia Nalubowa and Jennifer Anguko, both of whom died unnecessarily in childbirth.

CEHURD filed this petition on 3rd Match 2011 and the same has not been heard up to date.  On 11th March 2011 the Attorney General filed a response, on 27th May 2011 Scheduling conference took on before you. On 7th July 2011 the case was fixed for hearing but unfortunately it was not heard due to lack of quorum. On 20th July the case was fixed again for hearing but the Attorney general requested for more time to secure two affidavits so the case was adjourned to 28th September 2011 on which date the case wasn’t heard due to lack of quorum.

On 26th October 2011 the case came up for hearing but an objection was raised to which the justices stated that they will be giving a ruling on the objection raised by the state Attorney on short notice.

NGOs give EU commission a beating over anti-counterfeit pact

BY NIKOLAJ NIELSEN

BRUSSELS – Amnesty Intentional, Oxfam, Reporters without Borders as well as internet rights groups and the Council of Europe all spoke out against the Anti-Counterfeiting Trade Agreement (Acta) at a European Parliament hearing on Wednesday (11 April).

“The vision set out by the Universal Declaration of Human Rights is at stake,” warned Marianne Mollmann, senior policy advisor of the London-based organisation human rights group Amnesty International.

Mollmann said the trade agreement threatens the right to the freedom of expression, the right to health, the right to due process and fair trial, and the right of an author to benefit from the protection of moral and material interests resulting from any scientific and literary production.

“These are all human rights that need to be balanced [in Acta], and they are not,” said Mollmann, adding that the trade agreement shifts liability of copyright infringement onto service providers and encourages private entities to enforce and police its users.

The NGOs raised a number of issues surrounding the controversial agreement, qualifying it as dangerous for promoting over-policing, unreasonable levels of surveillance, risks to privacy, and even development.

None of the NGOs present at the hearing had been invited and asked to provide input during the treaty’s negotiation, creating a cloak of secrecy that some believe has further undermined its legitimacy.

As an international trade agreement, Acta is supposed to help countries work together to tackle large-scale intellectual property rights violations, according to the European Commission. It also targets counterfeit goods and generic medicines.

But mounting public pressure and protests from around Europe may derail its ratification by the European Parliament, scheduled for either June or July.

EU trade commissioner Karel de Gucht last week requested the parliament refrain from any ratification until the treaty has been scrutinised by the European Court of Justice (ECJ), a process that could take months.

The European Parliament’s international trade committee, however, voted on 29 March not to send the treaty to the ECJ.

NGOs refute Commission’s claims on Acta
The commission claims the agreement is in line with European fundamental rights such as the freedom of expression and information or data protection and the right to property including that of intellectual property.

But experts at Wednesday’s parliament hearing, organised by Dutch Liberal MEP Marietje Schaake and Bulgarian Socialist MEP Ivailo Kalfin, all refuted the commission’s claims, arguing instead that there is a clear imbalance in the favour of intellectual property rights rather than natural rights.

The treaty mentions intellectual property rights 43 times. Fundamental rights are not mentioned at all, while freedom of expression is mentioned twice as a principle rather than as a right, said Gabrielle Guillemin, a legal officer at the London-based NGO Article 19.

“The criminal provisions under Acta lack the legal certainty required under international law, under article 10 of the European Convention on Human Rights as well as article 52 of the EU Charter of fundamental rights,” she explained.

The commission also says the treaty would safeguard European businesses, promote growth, stimulate innovation and create and protect millions of jobs. Again, experts at the hearing refuted the claims.

Sebastiano Toffaleti of the Pan European ICT & eBusiness Network for small businesses (PIN-SME), which represents some 50,000 small-ish IT companies, said the treaty would instead undermine European enterprise and innovation.

“Acta would hamper innovation and growth of SMEs that develop content and market it online,” said Toffaleti.

According to Toffaleti, criminal liability threats in the treaty would deter internet service providers (ISPs) from hosting products developed by SMEs irrespective whether the claims are legitimate or not.

Meanwhile, a US-based study, entitled The Sky is Rising , concluded that the entertainment industry grew by 50 percent in the last decade. The overall industry, including books, music, video games and films, grew from €341 billion in 1995 to €567 billion in 2010.

The study infers that the commission’s argument that Acta is needed to safeguard and promote such sectors is not based on fact.

“More content is being produced than ever before,” said Mike Masnick, who conducted the study. “More content is available to the public than ever before. In short, we found that the overall industry is thriving.”

Source: http://euobserver.com/22/115846

UGANDA: Senior health officials suspended amid TB drug shortage

KAMPALA/GULU, 23 March 2012 (PlusNews) – Uganda’s Minister of Health, Christine Ondoa, has suspended several senior health officials, including the managers of the national HIV/AIDS and tuberculosis programmes, for poor performance and drug shortages.

Health centres across the country have been facing critical shortages of TB drugs in recent weeks and officials say the lives of an estimated 50,000 people have been put at risk as a result.

Dr Francis Adatu, the national manager of the TB and Leprosy Control Programme, was suspended over a critical shortage of TB drugs, and Dr Zainab Akol, programme manager for HIV/AIDS, over the unstable supply of antiretroviral (ARVs) drugs. Her suspension comes one week after a national AIDS Indicator report revealed an increase in the HIV prevalence rate from 6.4 percent to 6.7 percent.

Three other senior managers – Dr James Sekajugo, the programme manager for non-communicable diseases, Sarafin Adibaku, in charge of the Malaria Control Programme, and Rachael Senyange, from the UN Expanded Programme on Immunization, were also asked to leave office immediately. Dr Robert Basaza, a senior planner arrested on 20 March to assist the police with their financial investigations, was also suspended.

“I have withdrawn her [Akol] and four others from their assignments. I have adopted the changes to overhaul the departments in order to improve on service delivery, supervision, monitoring and financial management,” Ondoa told IRIN/PlusNews. “I have left it to the technical persons [permanent secretary and director general of health services] to get people to take over the management of the programmes.”

At Gulu Hospital in northern Uganda, 37 newly diagnosed patients and more than 50 continuing patients are without TB medicines. “The TB clinic has been running without drugs for the past three months,” said Rebecca Akuu, the senior nursing officer at the TB clinic. “We are telling patients to keep checking.” IRIN/PlusNews found frustrated and frightened patients at the clinic. “I don’t know what to do, my life is in danger,” said Otto Ayella. “My cough is getting worse… making it hard for me to breathe.”

Blame game

Shortages of ARVs and drugs to treat TB and malaria occur frequently in Uganda.

Dr Asuman Lukwago, permanent secretary in the Ministry of Health, told IRIN/PlusNews that most public health facilities had run out of drugs due to changes in the procurement and supply responsibilities introduced by the new Public Procurement and Disposal of Public Assets Authority (PPDA) international guidelines.

Drugs were previously procured by the National Tuberculosis and Leprosy Centre, but since late 2011 the procurement and distribution of drugs and pharmaceutical products has been handled by the National Media Stores (NMS), an autonomous government corporation. The new procurement policies are aimed at improving the management of the supply chain.

“It’s true we have some problems… The transition will be managed. We are doing everything possible to have drugs distributed to the affected hospitals,” Lukwago said.

Moses Kamabare, the NMS general Manager, blamed the current drug shortage on a shortfall in foreign funding. “The government has just now started funding the drugs,” he said. “The country had some problems with the Global Fund [to fight AIDS, Malaria and Tuberculosis]. This brought some shortages. However, we now have… drugs… for three months.”

Kamabare said part of the blame also lay with local health authorities who did not put in requests for drugs on time. “If they don’t requisition, we can’t know whether they have the drugs or not. We can’t keep following up on them.”

Photo: Charles Akena/IRIN

Supply chain problems have led to regular drug shortages

Rectifying the situation

Health Minister Christine Ondoa said the government has procured enough TB drugs to cater for 50,000 patients for the next three months. “We want to assure the public that there is no cause for alarm as there are now sufficient drugs. All patients are therefore advised to report to health facilities for treatment,” she told a recent media briefing.

The procurement of medicines for the next six months with funding from the Ugandan government was ongoing she said, and the government had also, for the first time, procured second-line TB drugs for 250 patients diagnosed with multidrug-resistant TB. “The first consignment of TB drugs under the Global Fund arrangement will arrive in the country in September,” she added.

Dr Nathan Nyachi the director of Gulu Hospital, confirmed that medicines were now available. “We have the drugs. I have just been collecting the hospital’s consignment, and for several other health units in the district,” he told IRIN/PlusNews.

An estimated 102,000 Ugandans become infected with TB annually, and about 50,000 cases have been diagnosed and are on treatment. The country ranks 16th on the UN World Health Organization’s list of 22 high-burden countries that make up 80 percent of global TB cases.

Source: http://www.plusnews.org/PrintReport.aspx?ReportID=95134

Bugiri Hospital suffers brain drain

By Frederick Womakuyu

FROM the Bugiri-Malaba highway, Bugiri hospital appears to be a deserted facility. The tin roofs hovering over the facility are rusted, its doors broken down and the infrastructure is dilapidated. But coming closer to the facility, you see a number of patients are lining up for different services.

This is around 9:00am in the morning. However, a keen look around the facility reveals absence of the senior workers — the medical superintendent, the administrator and junior cadres, are yet to show up. I am told to wait. Within half an hour, the administrator shows up but she tells me to wait as she attends to the Resident District Commissioner of Bugiri, who had also showed up to check on the facility.

The hospital is in dire need of equipment ranging from beds to drugs. A fresh coat of paint would also be nice

After almost three hours, the administrator, Sarah Nabulime, a short talkative woman, invites me to her office. Nabulime starts by lamenting that as much as sick people fl ock the facility for treatment, the centre itself is “like a patient on drip.” Nabulime laments that the hospital has failed to retain its staff who vanish after training.

On the day I visited, the medical superintendent was away. He went for further studies but, unfortunately, after the course that was sponsored by the Government, he vanished.

TWO DOCTORS

The facility is also supposed to have three doctors but only two are available — the third went to Nairobi, Kenya for further studies. However, Nabulime fears that when he completes his studies, he is also likely to look for greener pastures elsewhere. Nabulime has lost count of the number of doctors from Bugiri hospital who enroll for further studies but never return. “Every year, we lose about three doctors who go for further studies and do not come back. According to Dr. Stephen Kirya, the Bugiri district director of health services, the staff of the facility stands at 52% against the 65% recommended by the Ministry of Health. “This seems like a good percentage but it’s the core staff who are missing,” he said. Kirya explains that while the facility is supposed to have about 12 doctors, they have only two. Out of the five specialists they should have, there is none. Because there are no specialist gynaecologists and obstetricians, every month, two babies and a mother die at the facility due to this shortage. Thankfully the facility has an x-ray and c-scan machine but no expert to operate it.

The infrastructure can best be described as sick. The beds in each ward are broken, mattresses torn or missing and the few available ones are dirty. The beds are also few forcing some of the patients to sleep on the floor.

The ceiling needs to be replaced

Yet deep in the toilets and bathrooms, a sanitation problem that is likely to cause disease is going on. The toilets are all broken down; sewerage leaks inside the wards and into the consultancy. The floor, walls and the entire infrastructure is dirty, dilapidated and unsuitable for human use. The facility uses water from an electric pump. However, power cuts have forced the facility to go without water for weeks. The maternity ward has become so filthy – a powerful stench that is indescribable threatens lives there. “Life is tough in this hospital. We have talked to the district to give us more money to buy fuel for the generator to power the whole hospital but the district is also broke,” adds an health worker, who preferred anonymity.

SHOE STRING BUDGET

Bugiri district prepares an annual budget of sh20b but they get only sh50m. However, at the end of each month, they use over sh20m to run the hospital. The facility budgets for sh1m per month to buy fuel for the generator but their annual budget for running the generator is about sh15m. “This clearly shows you the shortage we face,” adds Dr. Kirya.

Dr. Kirya explains that when there is no power or generator, they are always forced not to carry out any surgeries refering the cases to Iganga or Jinja hospital. However, by the time they cover a distance of about 30km to Iganga or 60km to Jinja, the patients are dead. No wonder, at the facility, 600 people – including children, women and men die annually. While the facility, like any other in the country receives its drugs, medicines and supplies from the National Medical stores, the supplies are often inadequate. Essential drugs like malaria, anti-biotics are often out of stock. And simple supplies like gloves, gauze, cotton, syringes and intravenous fluids are often out of supply. But she is also frustrated that they have promised each year in and out but nothing has so far come. Patients like Alice Nantume who has just given birth without the help of a doctor but a nurse, are desperate.

“I came here to get better care but life is instead tough. At least in the village, a traditional birth attendant will give you some herbs but here there is nothing.” Nantume explains that she did not fi nd any gloves, so she was advised to buy some. She also brought her own soup since the facility did not have any. “We request the government to help us,” she pleaded.

WAY FORWARD

Dr. Kirya calls upon the Government to help them recruit human resource and pay them well, “because the districts do not have capacity to attract and retain health workers. It is a pity but we need help.” Nabulime calls on the government to speed up the plan to rehabilitate the facility to give it a new facelift. Bugiri district chairman Malijani Azamwa Balubireire called upon the Government to increase funding to local governments and also stop creating more districts so that they are able to pay health workers well.

source:  http://www.newvision.co.ug/news/629245-bugiri-hospital-suffers-brain-drain.html