European drug regulation at risk of stalling as agency prepares to leave London

First published in Nature, 12.10.2017

Drug regulation in Europe could temporarily freeze if the European Medicines Agency (EMA) loses staff during its post-Brexit move from London. Up to 70 per cent of its 900 staff have said they would quit if the agency relocated to some of the cities bidding to host the organisation.

According to a battle plan drawn up by agency management, failure to retain enough staff would result in a shutdown of essential operations until more people could be hired. If fewer than 30% of the staff move with the agency to its new destination — to be decided next month — it would cease operation, Guido Rasi, the agency’s executive director, told Nature.

The EMA, an agency of the European Union, needs to leave London — where it has been headquartered since 1995 — as a result of Brexit. In addition to its permanent staff, the agency hires many other experts on a short-term basis. Following an internal staff survey undertaken in September, the agency urged European heads of state to pick a location to which at least 65% of staff would relocate.

Bids for a home

Some 19 cities across Europe have applied to host the prestigious organization. Last week, the EMA released its own assessment of the applications, and warned that several locations are entirely unsuitable for the agency’s location. Proposals for Sofia, Malta and Warsaw met almost none of the requirements put forward by the agency and could result in huge staff losses, Rasi warned. Amsterdam was the most popular alternative to London.

“The best case is, of course, a continuum of our activities, with only about 20% staff loss,” he says. “The worst case scenario we have come up with is 94% staff loss. For our business-continuity plan, we found three levels of activities we can delay, put on hold or stop completely.”

According to Rasi, the agency’s core mission — the regulation and monitoring of innovative drugs across Europe — would be the last thing to stop. But even with 50% staff loss, the agency would have to reduce advisory support to new research projects, which could stall work on innovative medicines, he says (see ‘European Medicines Agency chief raises alarm at forced relocation‘).

The agency assesses all medicines, including veterinary products, to be sold on the European market, and passes on recommendations to the European Commission for authorization. It evaluates reports of adverse reactions and, if necessary, works with national agencies to ban medicines that are suspected of being dangerous. The EMA also has in-house scientists who provide advice to drug developers on which criteria they need to fulfil to get a product passed.

In 2016, the agency recommended 81 new medicines for authorization and answered more than 450 requests for scientific advice.

Medication mediation

The European Federation of Pharmaceutical Industries and Associations, headquartered in Brussels, has called on member states to put the agency’s well-being first when choosing a location. “There are many cities that could have the right criteria for the agency to settle,” said a spokesman. “There is a potential for disruption, but also a potential for harmony. It all depends on what you choose.”

In the United Kingdom, pharmaceutical companies worry about how they will get their medicines approved after Brexit. The BioIndustry Association, a group of British life-sciences companies, has backed a UK government proposal to maintain authorizations for medicines granted before Brexit and the continuation of work with the agency during a transition period.

“The alternative — organizing and delivering a wholesale change — would be a gargantuan task for companies and regulators across the UK and Europe,” says Steve Bates, the association’s chief executive officer. “It would be extremely challenging to successfully deliver in the short amount of time left until Brexit in March 2019.”

Meanwhile, the uncertainty about the agency’s future is already causing problems. The agency has been unable to fill a position as head of veterinary medicine; all three potential candidates said that they would wait for the final location to be announced before deciding whether or not to take the job, according to Rasi.

Europe’s heads of state will meet on 18–20 October to begin hammering out an agreement. A decision is due to be announced on 20 November, at the next EU General Affairs Council meeting.

United Kingdom sees dip in European research applications after Brexit vote

First published in Nature, 21.09.17

21 September 2017

The number of researchers applying for Europe-funded Marie Curie fellowships in the United Kingdom has dipped slightly since the country’s vote to leave the European Union, data released to Nature show. But there is no evidence yet of a sharp collapse in interest, which some scientists had feared in the wake of the Brexit referendum.

Every year, the European Commission funds thousands of experienced researchers — most of them European — to undertake work in other EU countries, typically for one or two years, with individual fellowships usually worth between €150,000 (US$180,000) and €200,000. More than 9,000 academics have applied for the popular programme this year, in an application round that closed on 14 September. Of those, 1,997 people — around 22% of the total — requested to work in the United Kingdom. In 2016, the United Kingdom had received 2,211 applications, some 25% of the total that year; while in 2014, the UK share of applicants reached 28%.

Continue reading this article here.

UK universities push for last-minute Erasmus deals

First published in Research Europe, 23.02.17

Universities in the UK are rushing to sign Erasmus+ deals to secure access to Europe for their students and academics after Brexit, Research Europe has learned.

Universities in Germany and Denmark have said that they are witnessing an increase in UK demand for partnerships under the EU’s flagship exchange programme, including deals on researcher exchange. They hope that agreements signed before Brexit will survive even if the UK pulls out of EU programmes.

EU destinations remain attractive for British students and researchers, said Tobias Hochscherf, a vice-dean at Kiel University of Applied Sciences in Germany, which has received more offers for Erasmus+ deals since the Brexit referendum in June 2016.

“The EU as a community of values has generally much in common with academia: both are built upon debate and partnership,” he said. “But what is irritating at the moment, for both students and staff, is the state of uncertainty.”

The UK risks losing significant clout and funding if it is forced to withdraw from Erasmus+. Last year was the country’s most successful year in funding terms, with €126 million awarded to UK universities compared with €118m in 2015. According to the British Council, an education and culture body, more than 40,000 people from the UK went to Europe to study or do research under Erasmus+ in the 2015-16 academic year.

A source from the British Council, which hosts the UK National Agency for Erasmus+, said that the programme had helped UK universities “broaden their connections and increase their competitiveness”. The council said that it was aware of a rush by British institutions to get agreements signed, but added that it could not speculate on future scenarios.

The European Commission echoed that it was too early to tell what was going to happen to UK participation. However, a spokesman for Erasmus+ said that the option of a Norway or Switzerland-style deal—where the country pays into the programme in return for access—could be tricky, because UK prime minister Theresa May has said she opposes “huge payments” to the EU after Brexit.

Meanwhile, the general situation remains a concern for the UK’s EU partners. Hochscherf said that he has stopped looking for joint EU research bids with partners in the UK, at least for now.

“What I fear is that higher education and research will be used as a bargaining chip in the negotiations between Westminster and Brussels,” he said.

EU climate spending criticised by auditors

31.11.16 – Original story on Climate News Network

The EU is billions of euros below its climate target and there are insufficient checks on where much of the €1 trillion budget is going.

The European Union could miss its climate spending targets due to fragmented funding and inflated numbers, warns the European Court of Auditors (ECA).

Although in percentage terms the figures look small, the fact that the total budget is €1 trillion means a great deal of money is being spent on purposes other than mitigating or adapting to climate change.

A report by the ECA reveals that some of the funds labelled climate adaptation were “not proven” to be that. If other criteria were used, the actual spending on climate-related issues in fisheries and agriculture alone would be €33 billion less than estimated.

The report says the EU will spend just under 19% of its budget on climate-related activities by 2020, short of the union’s 20% spending goal. Between 2014 and 2016, EU climate spending hovered at around 17.6% of the budget, but did not increase significantly, the auditors found. Spending was meant to have reached 19.7% of the total budget by 2017.

With the EU budget for 2014-2020 standing at just over €1 trillion, the projected loss of climate investment could be in the billions.

Fragmentation

One reason for missing the target is the fragmentation of EU climate spending, the auditors say. Instead of pooling the funding into one climate action pot, the European Commission decided to channel money from different streams towards climate activities, leaving it up to the respective fund managers to decide how this would be done.

Sources of climate funding include fisheries, farming and technology development. In these areas there has been “no significant shift towards climate action and not all potential opportunities for financing climate-related action have been fully explored”, says the ECA.

Markus Trilling, finance policy coordinator at the watchdog Climate Action Network, thinks the EU needs better management of its spending. “Large parts of the funding to European farmers, both direct payments and under rural development programmes, are labelled climate adaption, but positive environmental impact is not proven,” he says.

Another reason behind the shortfall identified by the auditors in their 22 November report is the European Commission’s habit of using planned expenses, which, the report says, do not always mirror actual spending.

“The European Commission should immediately
improve its so-called ‘climate action tracking’
methodology to get a more accurate picture of the
volume and actual impact of climate action spending”

However, a spokeswoman for the European Commission’s climate action directorate says efforts to ramp up climate activities are under way, and that the EU is still broadly on track to meet the target by 2020. “We have already managed to integrate climate-related spending into our policy and this is an achievement of its own,” she told Climate News Network.

Such efforts, however, have not extended to all parts of the climate action budget. Horizon 2020, the EU’s research programme, spends only 24% of funds on climate-related work, while its target is set at 35%, the auditors reveal.

Furthermore, they say that the EU lacked a specific plan as to how it would ensure programmes that have fallen behind will catch up. Spending on climate action would have to increase by 22% every year until 2020 for the target to be met, the report found. “Progress has been made, but in key spending areas it is largely business as usual,” says Phil Wynn Owen, the auditor who oversaw the compilation of the report.

Climate tracking

In addition, the EU’s efforts to track climate spending are poor, the auditors say. If the commission used what the court deems “internationally established methodologies”, such as those used by the OECD, actual climate spending under the agriculture and fisheries heading would be around €33 billion less than currently estimated.

“The European Commission should immediately improve its so-called ‘climate action tracking’ methodology to get a more accurate picture about the volume and actual impact of climate action spending,” says Trilling.

The EU’s 20% spending promise is a vital contribution to meeting the UN emission reduction targets set out for its member states. According to Trilling, the EU cannot maintain its aspirations to lead on the Paris Agreement if spending is not ramped up in time to meet the promise. To be a climate action leader, “the whole EU budget has to be 100% climate-proof”, he says. – Climate News Network