Connect with us


After Amsterdam high, EU drugs regulator feels the pain

The European Medicines Agency’s move to Amsterdam after Brexit was supposed to make for smooth saili..

The European Medicines Agency’s move to Amsterdam after Brexit was supposed to make for smooth sailing and a happy 900-member staff.

As the afterglow of winning the contest to host the EU’s drug regulator subsides, some unpleasant realities of the shift to the Dutch capital are coming to light.

The building that will eventually host the agency will not be ready until the end of 2019 or even early 2020, according to two Dutch officials. The EMA has to move out of London by the end of March 2019, so it faces using one or more temporary buildingsin different parts of Amsterdam for its sensitive work on drug approvals until the new permanent premises are ready.

An EMA official wrote that “each of the proposed temporary premises has weaknesses which raises concerns about EMA’s continuity of operation even if this is only for a period limited in time,” according to an internal email from November 28seen by POLITICO.

“We know that it will not be smooth, they know,” EMA Executive Director Guido Rasi said, pointing to Dutch officials at a meeting with all agency staff in London on November 24, according to a video recording of the meeting seen by POLITICO. “We already shared some common concerns, which means that we are realistic, we are not overpromising, but we are deeply committed to make it the best that can be done.”

Delivering on promises and expectations

Amsterdam topped the preferences of EMA employees in a September survey, with 81 percent of them saying they would move to the Dutch city if the agency relocated there.

“Amsterdam ticks many of our boxes,” Rasi said soon after the city was chosen to be the new host. “It offers excellent connectivity and a building that can be shaped according to our needs.”

Amsterdam won’t even settle on a contractor for the EMA’s new building until March 2018

The city has a major airport connecting it to the rest of the world and is just across the English Channel from London. The Dutch promised to ensure the agency could function seamlessly after its relocation. Amsterdam’s proposed transition plan included individual support for each agency employee and doing whatever it took to get the building site ready.

“We also have a very stylish queen and eat fish and chips,” boasted the video presenting Amsterdam as the perfect new home for the EMA.

The Netherlands made it clear when applying to host the EMA that the new offices wouldnot be ready by March 30, 2019, when the agency needs to move out of London because the U.K. ceases to be an EU member that day. It didn’t specify when the agency’s building would be fully ready, though, noting only that the offices would be made available throughout 2019.

The European Medicines Agency building in Canary Wharf | Neil Hall/EFE

What it did promise was critical conference facilities would be ready by April 1, 2019, the first working day after Brexit. The EMA relies heavily on experts from across the EU coming together to assess new drug applications, which is why those fully equipped conference facilities are the agency’s most urgent need.

Amsterdam says those meeting rooms in the new building will be ready by April 1, 2019. But that leaves no time to address any issues that come along with new construction. And while the Dutch bid promises to deliver meeting spaces, it’s not clear it will have the 4G internet connection, audio and video conference equipment, and a voting system per seat to satisfy EMA needs from Day One.

And it will be a further seven or eight months before the time the rest of the building is completed and all EMA staff are in one place, said Udo Kock, Amsterdam’s deputy mayor for finance and economic affairs.

Temporary workspaces for some staff could “have implications for the operational efficiencies during the transition period,” said one assessment published in September which was commissioned by the pharma lobby EFPIA. It’s not yet clear whether staffers would be split between multiple sites in Amsterdam.

One proposed temporary office building is two metro stops away or a maximum 10-minute walk from the EMA’s ultimate destination in Amsterdam, Maurice Galla, the project leader of the Dutch EMA candidacy, said at the EMA meeting.

“The biggest hurdle is that by the time we have to move, our new building in Amsterdam will not be ready for us,” Rasi told members of the European Parliament’s environment and public health committee Thursday. “We are working with the Dutch authorities to find another solution — the temporary building will be crucial for our business continuity as of March 2019.”

Winning strategy becomes Achilles’ heel

Constructing a new building was supposed to be a strength of the city’s bid, with the Dutch authorities wanting to give the EMA a fully customized new home similar to the one it has to leave in the Canary Wharf business district of London, Kock said.

For others in the 16-way race to win the agency that had a ready-made space, including Italy and Denmark, Amsterdam’s win may now seem especially bitter. The Italian and Danish cities competed head-to-head with the Netherlands in the three-round voting session on November 20.

The agency needs a minimum 850 workspaces and 15 internal meeting rooms.

Amsterdam won’t even settle on a contractor for the EMA’s new building until March 2018, Marcel van Raaij, a director in the Dutch health ministry, told EMA staffers at the November 24 meeting.

And an internal EMA email sent late November 28, after the EMA staffers in charge of the relocation visited the premises in Amsterdam, raised concerns that the proposed temporary premises had weaknesses, “especially in terms of the amount of workspaces, of internal meeting rooms, of facilities as regards reprographics, local archiving.” The agency needs a minimum 850 workspaces and 15 internal meeting rooms, with at least one of them able to host 30 people and the necessary space for reprographics and internal archives, preferably in only one building, the email said.

“Therefore due consideration should be given first at finding alternatives where not only these weaknesses can be addressed, but in addition also external meeting rooms could be provided (to minimize as much as possible travel time for staff for running and contributing to the external meetings),” the email said.

The EMA has to move out of London by the end of March 2019 | Robin Utrecht/EFE via EPA

This email is “completely outdated,” an EMA press officer said, adding that site visits are ongoing and that a first official step on the relocation process will be announced at the EMA Management Board scheduled for December 13 and 14. A spokesperson for the Dutch Health Ministry said it does not recognize concerns about the weaknesses of each of the proposed temporary premises because the EMA team is still visiting some of the potential temporary buildings.

A European Commission assessment in September said the office floors were expected to be ready as much as six months after April 1. The Commission did not inspect the building plans and said it was up to the country that won the agency to comply with the promises it made in its bid.

Asked whether the Commission can help speed up the building in any way, one Commission official responded: “Volunteer.”

Original Article


The post After Amsterdam high, EU drugs regulator feels the pain appeared first on News Wire Now.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *


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…)

Continue Reading


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.

Read from source

Continue Reading


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…)

Continue Reading