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Europe struggles to face down Big Pharma

Belgium and the Netherlands teamed up three years ago to negotiate cheaper drugs in the hopes of for..

Belgium and the Netherlands teamed up three years ago to negotiate cheaper drugs in the hopes of forming a new front against Big Pharmas high prices.

It was an attractive idea: Banding together, EU health ministries would wield bargaining power against pharma companies based on their bigger patient pool. Luxembourg, Austria and Ireland agreed with the logic and signed on, stung into action as drug prices reached eye-popping highs. Hepatitis C drug Sovaldi reached a price of €50,000 per full treatment course in 2014, and many cancer drugs have shot past €100,000 for treating one patient.

“By joining forces, we stand stronger against the power of the pharmaceutical industry and we can also deliver a clearer voice at the European level,” Dutch Health Care Minister Bruno Bruins said when Ireland joined in February.

It hasnt quite worked out.

Three years since the launch of the pact, the lack of any concrete deal shows that EU countries will have to play a longer game than initially thought.

That hasnt deterred imitation. Nine countries mainly from the EUs south and southeast got together in the so-called Valletta Declaration group last May. The group now includes Cyprus, Greece, Ireland, Italy, Malta, Portugal, Romania, Spain and Slovenia. Croatia intends to join, according to the groups technical committee.

The number of countries in a group, their languages and their legal differences also make cooperation challenging.

In Central and Eastern Europe, Poland is leading an alliance that includes Hungary, Slovakia and Lithuania. The Czech Republic is an observer and may sign on.

Each of the three groups has its own potential advantages, with the Valletta Declaration countries representing almost 160 million people, for example. But the number of countries in a group, their languages and their legal differences also make cooperation challenging. And the Valletta Declaration and the Central European group have barely started work.

Heres how they are all doing.

BENELUXAI

Belgium and the Netherlands were the trendsetters but have run into various problems that have prevented them from making breakthroughs. They and their three partners have significant differences on how decisions are made on what medicines should be paid for by the health system and timelines about when these decisions should be made.

The expansion of the group beyond the two original Dutch-speaking administrations created an extra layer of linguistic complications. The group had to start performing assessments of added value of medicinesin English to be comprehensible to all the countries involved.

The five countries are negotiating prices with several drug companies, said an official from one of the countries, who was not authorized to speak on the record, without being able to disclose what those were. Some of the drugs under discussion have not yet been approved in the EU.

The only negotiation Belgium and the Netherlands have made public is when they didnt strike a deal with drugmaker Vertex for a cystic fibrosis medicine called Orkambi, because they couldnt agree on the price. No figure was disclosed, but the drugs official price in December 2016 in Ireland was estimated at €159,000 per patient per year.

The Dutch eventually negotiated with Vertex on their own, because Belgian law prevented the government from restarting negotiations within six months of them collapsing. The Netherlands struck an agreement in October for an undisclosed price.

Vertex is one of the smaller drugmakers willing to engage with the cooperating countries, as its negotiations with Belgium and the Netherlands show.

Big Pharma has been more reluctant. The European pharma lobby group EFPIA said it supports “any initiative that helps drive access to new medicines for patients” such as joint assessments of clinical added value. “However, price should remain a member state competency based on each individual countrys circumstances,” it said.

While the Belgo-Dutch negotiations with Vertex didnt work out as hoped, the fact that the two countriescould negotiate together was an encouraging sign the concept could still work, a national representative said.

The European pharma lobby group EFPIA said it supports “any initiative that helps drive access to new medicines for patients” | Christopher Furlong/Getty Images

Drug price negotiations are the most politically sensitive of the groups efforts. Other work includes assessing the added therapeutic benefit of certain new drugs and work to get insight into what drugs will hit the market over the next two years.

“Many of the concrete outcomes that we see are not really something you can discuss publicly,” said Vinzent Rest, the Austrian country coordinator for the cooperation. But all the common work would eventually give results that could be shared, Rest said he believes.

The Valletta Declaration

A more ambitious initiative pulling together nine countries that started last year is just getting off the ground.

Countries of differing sizes, from Cyprus and Malta to Italy and Spain, want to follow in the steps of BENELUXAI in jointly assessing the added value of medicines and negotiating prices together.

A technical committee was set up to prioritize the medicines that should be considered for joint negotiations, based on the diseases they treat, their cost and whether they respond to an unmet need for treatment. Agencies from two participating countries then evaluate the added benefits of the drugs.

The group is assessing one drug for a rare disease and a second one that couldnt be disclosed, said Rui Dos Santos Ivo, the vice president of the Portuguese drug agency executive board and a member of the committee. The endgame is to negotiate the price of these two drugs for a population the size of about a third of all of Europe.

Portugal and Spain announced a month before the start of the Valletta Declaration group that they wanted to negotiate drug prices together.

Before they get to the negotiations, the countries have a lot of decisions to make, said a representative of one of the countries involved who was not authorized to speak on the record. Will the prices be set for all countries or will there be a range of prices for different members? Will drugmakers have to negotiate with each national authority or with a smaller group representing all countries? These questions came up in a discussion between the Valletta Declaration group and Roche, one of first companies it spoke with, according to the official.

The group meets in April in Lisbon to try to settle on some of the answers.

Some countries want a price ceiling, while smaller countries want a fixed price, the official said. Bigger countries want to set a range of prices and have national authorities negotiate them, because they already have the expertise, the official said.

“We are sailing in uncharted territory both politically and technically, legally. One cannot really predict whats going to happen,” the official said.

Irish Health Minister Simon Harris | Olivier Hoslet/EPA

Ireland is curious enough to find out: It decided to put its eggs in more than one cooperation basket. The country is the only one that belongs to two regional groups. Membership is not mutually exclusive, Irish Health Minister Simon Harris told POLITICO last June. At some point all these groups will have to come together around common interests, he said.

Portugal and Spain announced a month before the start of the Valletta Declaration group that they wanted to negotiate drug prices together. Their first target has been to procure vaccines together, also betting on getting a lower price together than on their own, according to one of their Brussels-based diplomats.

The Fair Pricing group

This Central European regional cooperation group comprising Poland, Hungary, Slovakia and Lithuania is also a year old and taking initial steps toward joint negotiations of drug prices, despite differences in national legal systems.

A coordination committee representing each country selects the drugs the group wants to negotiate on, and the first target is a breast cancer medicine, said Marcin Rynkowski, director of the international cooperation department at Polands health ministry.

“Its all new for us and we have to pave the way” — Marcin Rynkowski, director at Polands health ministry

National authorities from each country will negotiate with the drugmaker in parallel, with each of them trying to get the lowest price, he said. The countries will then share information on the price they reached.

When he spoke to POLITICO last May, Lithuanian Health Minister Aurelijus Veryga hoped this international cooperation would bring down prices for his country of almost 3 million. Together with the other three countries, Lithuania is part of a market of almost 60 million people, which greatly increases its bargaining power.

But the different national systems are a challenge to a smooth-running operation. Negotiating a drug price together without changing laws in some countries would be difficult, Rynkowski said. “Its all new for us and we have to pave the way.”

Shirley S. Wang contributed reporting.

This article is part of a series on drug pricing, Pharmas Market.

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Burkina Faso: Growing Violence Threatens Health Care

Away from the worlds attention, Burkina Faso has been slipping into violence. In less than a year, t..

Away from the worlds attention, Burkina Faso has been slipping into violence. In less than a year, the number of displaced has increased fivefold, from 50,000 last December, to 270,000 in August. As ever, the most vulnerable suffer most: the very young, and the very old.

When Alidou Sawadogos elderly mother fell ill, he faced a long and dangerous journey to get treatment for her.

“When she collapsed, a friend called me,” he explains. “By the time I arrived she was already unconscious. I decided to take her to the health center and luckily someone who had a motorcycle helped me. Because of the violence many people who are sick wait at home and die. Everyone is afraid of taking the road to the health center in Barsalogho.”

Across Burkina Faso, the rising insecurity has forced over a hundred health centers to close, or to limit their work. Half a million people now have little or no access to health care. Dedicated health workers, among them Dr Bertrand Dibli in Barsalogho, are struggling to meet the needs, and to stay safe themselves.

“This is one of the few health centers that isnt closed,” he says. “We dont have enough equipment. And the insecurity has caused huge anxiety among health workers. Even coming here to Barsalogho is a huge challenge because the route is so dangerous.”

The ICRC has been working to support Burkina Fasos health professionals, with medical kits, and vaccination campaigns. During his visit to the country, ICRC President Peter Maurer expressed his concern at the multiple challenges facing Burkina Fasos people.

“We are very concerned,” he said. “Very worried about the upsurge in violence, its a vicious circle that is trapping the civilian population between armed groups.”

“We also see,” Mr Maurer added, “that it is not only the violence that is affecting the country, it is also under development, and climate change. Together with the violence that is obstructing the health services, its an accumulation of factors.”

And so the ICRC – jointly with the Burkinabé Red Cross – is also delivering food to the displaced, and helping to improve access to water supplies. All of this, says nurse Jeanette Kientega, is desperately needed by a population uprooted by conflict, and denied access to basic health care.

“By the time they are able to get here, it is often too late” she says. “Sometimes we can help, but if they have already been ill a long time, it is difficult. We try to do what we can.” (more…)

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World Bank and WHO Statement on Partnership & Deployment of Financing to WHO for Ebola Response in DRC

WASHINGTON, August 23, 2019—The World Bank and the World Health Organization (WHO), along with the G..

WASHINGTON, August 23, 2019—The World Bank and the World Health Organization (WHO), along with the Government and other key partners, are working in close partnership on the Ebola Crisis Response in the Democratic Republic of the Congo (DRC). Central to this partnership is the assessment of the financing needs, and deployment of resources, with the goal to put an end to the current deadly outbreak.

The World Bank is today announcing that US$50 million in funding is to be released to WHO for its lifesaving operational work on the frontlines of the outbreak. The WHO is announcing that this US$50 million in funds will close the financing gap for its emergency health response in DRC through to the end of September 2019, and is calling on other partners to mirror this generous support in order to fund the response through to December.

The funding comprises US$30 million from the Pandemic Emergency Financing Facility (PEF) and US$20 million from the World Bank. The US$50 million in grant funding is part of the larger financial package of approximately US$300 million that the World Bank announced last month to support the fourth Strategic Response Plan for the DRC Ebola outbreak.

“WHO is very grateful for the World Banks support, which fills a critical gap in our immediate needs for Ebola response efforts in DRC, and will enable the heroic workers on the frontlines of this fight to continue their lifesaving work,” said Dr. Tedros Adhanom Ghebreyesus, Director-General, World Health Organization. “We keenly await further funding from other partners to sustain the response through to the end of the year.”

The DRC government, working in collaboration with the World Bank, WHO, and other key partners, has finalized the Fourth Strategic Response Plan (SRP4), which outlines the total resources needed for the DRC Ebola Crisis Response from July to December 2019. The financing announced today is part of the World Banks previously announced financial package of up to US$300 million and covers over half of SRP4s needs, with the remainder requiring additional funding from other donors and partners.

“The World Bank is working closely with WHO, the Government of DRC, and all partners to do everything we can to put an end to the latest Ebola outbreak,” said Annette Dixon, Vice President, Human Development at the World Bank. “The partnership between our organizations and the Government is critical for responding to the emergency as well as rebuilding systems for delivery of basic services and to restoring the trust of communities.”

The Government of DRC requested US$30 million from the PEF Cash Window to be paid directly to WHO. The PEF Steering Body approved the request bringing the PEFs total contribution to fighting Ebola in DRC to US$61.4 million. The PEF is a financing mechanism housed at the World Bank; its Steering Body is co-chaired by the World Bank and WHO, and comprises donor country members from Japan, Germany and Australia. The quick and flexible financing it provides saves lives, by enabling governments and international responders to concentrate on fighting Ebola—not fundraising.

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Borno State launches first Malaria Operational Plan, reawakens fight against malaria

Maiduguri, 13 August 2019 – Following recommendations from malaria interventions in Borno State Nige..

Maiduguri, 13 August 2019 – Following recommendations from malaria interventions in Borno State Nigeria, the Malaria Annual Operational Plan (MAOP) was developed and launched on 08 August 2019 with technical support from the World Health Organization (WHO) and partners. Aligned to the National Malaria Strategic Plan (2014 -2020), MAOP was developed through a broad-based stakeholders workshop involving malaria stakeholders, reviewed on different thematic areas and endorsed by the Commissioner for Health and Permanent Secretary, Borno State Ministry of Health.

Speaking during the launch, the Borno state Malaria Programme Manager, Mr Mala Waziri described the MAOP as the first to be endorsed and disseminated in Borno State. “WHO has made us proud by supporting the first ever Malaria Operational Plan right from development, review, printing to dissemination.”

Dr Ibrahim Kida, the Ministerial Secretary Borno State Ministry of Health and Incident Manager of the state, described the launch as “an historic event as stakeholders across the health sector made commitments to use the document as an implementation guide for all malaria programs”. The plan was also described as an advocacy tool for planning domestic funds mobilization.

The MAOP has seven objectives among which are: provide at least 50% of targeted population with appropriate preventive measures by 2020; ensure that all persons with suspected malaria who seek care are tested with Rapid Diagnostic Test (RDT) or microscopy by 2020 and all persons with confirmed malaria seen in private or public health facilities receive prompt treatment with an effective anti-malarial drug by 2020.

The MAOP will further ensure that at least 50% of the population practice appropriate malaria prevention and management by 2020, ensuring timely availability of appropriate anti-malarial medicines and commodities required for prevention, diagnosis and treatment of malaria in Borno State by 2020.

In addition, it seeks to ensure that all health facilities report on key malaria indicators routinely by 2020 and finally strengthen governance and coordination of all stakeholders for effective program implementation towards an A rating by 2020 on a standardized scorecard. These strategic objectives have specific targets and the MAOP takes into account the humanitarian response.

“Malaria remains a leading cause of poor health in Nigeria. According to the 2018 WHO Malaria Report, 53million cases are recorded annually in Nigeria, roughly 1 in 4 persons is infected with malaria contributing 25% of the global burden,” says Dr Nglass Ini Abasi, WHO Malaria Consultant for the North East.

“Furthermore, 81,640 deaths are recorded annually (9 deaths every hour), which accounts for 19% of global malaria deaths (1 in 5 global malaria deaths) and 45% malaria deaths in West Africa. The Nigeria Malaria Strategic Plan (NMSP) 2014-2020 has a goal to reduce malaria burden to pre-elimination levels and bring malaria-related mortality to zero and WHO is working assiduously with Government to ensure the burden is reduced accordingly.”

Results from WHO’s Early Warning, Alert and Response System (EWARS) week 30 report from 223 sites, (including 32 IDP camps) show that malaria was the leading cause of morbidity and mortality accounting for 35% of cases and 46% of reported deaths. In addition, results from the Nigeria Humanitarian Response Strategy (NHRS 2019-2021) indicate 7.1million people are in dire need of healthcare and 6.2million are targeted for immediate attention.

Despite recent improvements, insecurity remains a challenge limiting access to the functional health facilities. Easily preventable and treatable diseases such as malaria, acute respiratory infection and diarrheal diseases account for the greatest proportion of morbidity and mortality among the vulnerable population. Furthermore, Malaria is endemic in North East Nigeria and the transmission is perennial with a marked seasonal peak from July to November every year. (more…)

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