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A baptism of fire for Europe's new health commissioner

Controversial trade deals, the spread of Ebola and the threat of austerity are just three of the issues facing Dr Vytenis Andriukaitis
Vytenis Andriukaitis

A former health minister for Lithuania Dr Vytenis Andriukaitis is no stranger to hardship, having spent the first six years of his life in one of the Soviet Union's notorious gulags in Siberia.

But despite this difficult start, Dr Andriukaitis grew up to become a surgeon and a long-time member of his national Parliament.

His new role at the European Commission may however prove one of the toughest of his professional career, given the current ongoing challenges from both the economy and the healthcare sector.

Jean-Claude Juncker, the new president of the European Commission, and Dr Andriukaitis's new boss, wrote a letter to his new health commissioner in November saying: “You are becoming a member of the new European Commission at a particularly challenging time for the European Union.”

This is an understatement. And right now his biggest and most immediate concern is to keep Europe safe from the spread of Ebola from the neighbouring African continent.

The World Health Organization (WHO) in August declared the outbreak a global health emergency, with more than 7,000 deaths recorded in the past four months and around 16,000 people believed to be infected with the virus.

Ebola, one of the most lethal diseases known to man, is predominately contained in West Africa, but there have been a number of cases and even several deaths in European countries from those who have been working in the affected areas.

The African continent is also geographically very close to the southern European Union states, increasing the risk of the virus spreading, with both Italy and Spain having already had infected citizens in their countries.

The overall risk of a European outbreak remains low, but the media coverage has caused concern; the new Commission is also keen to help those in Africa contain the outbreak.

In one of his first duties in late November Dr Andriukaitis declared that more doctors, especially epidemiologists and other health professionals, will be needed to halt and eradicate the spread of Ebola. The best way to stop the virus from coming to Europe is to beat it at its source.

Speaking to journalists after returning to Brussels from the worst affected areas in Africa, he said: “We need these people to provide treatment and also to locate Ebola victims, guide them toward clinics, train local personnel, perform contact tracing, and implement awareness programmes.”

Pharma's view

Outside of epidemics, politically his appointment in itself came during a difficult period for the EU. The new Commission began a five-year cycle of power in September as it looks to shake up how it works, its structures and who within the Commission has responsibility for what.

But despite such a short period of power, it has already been mired in controversy on the health front after it announced plans to transfer its pharmaceutical policy from its health department to its industrial department. After much public professional obloquy, this was later reversed - this was not, however, the most auspicious of starts.

But despite this, many in the pharmaceutical industry are in fact optimistic that the new structure for health and pharma in the European Union can work in its favour.

Eli Lilly says that the new Commission structure of vice-presidents with specific projects and objectives “promises greater coherence for health and life science policy”.

The firm says: “An integrated life science approach looking across multiple policy areas could also help secure high value-added jobs, restart economic growth in Europe, and improve the health and well-being of an ageing population.”

The company's hope is that the restructured Commission will be more integrated, involving wider collaboration from commissioners dealing with overlapping issues. “This should not be on an ad-hoc basis, or a principle that is only adhered to in theory, but the start of a truly collegial approach that forms the basis of coherent integrated strategies,” the company says.

“A good outcome for patients and the biopharmaceutical sector would be for the current Commission mandate to deliver improved health outcomes and economic growth through better regulation and implementation, not simply more legislation and regulation.”

In a positive for the industry, Dr Andriukaitis is keen to push the agenda for better science and says he is 'disturbed' by the wave of distrust of science among the public. He told MEPs at his inauguration hearing that the EU needs to “increase public confidence in science” in policy-making.

He is also keen to progress the digital agenda. When asked by the German MEP Jens Gieseke what EU can do to promote e-health, he says he knows from personal experience that digitising health records would be an enormous help.

But when it comes to cross-border records he says: “The problem is Member States aren't communicating between themselves and different programmes don't work together. We need to ensure this process works smoother, which will be a top priority for me.”

He added: “As a cardio-surgeon who has worked a lot with electronic devices, that is a very topical issue.”

Economics and trade pacts

On the business side, the commissioner must also tread a difficult path as Europe's economy is still struggling with austerity and stagnation, with many countries such as Greece, Spain and Italy particularly feeling the pinch.

But even the biggest pharma market in the EU, Germany, narrowly missed going into recession at the end of 2014, showing just how delicate the recovery from the economic woes of 2007-08 remains.

For pharma, austerity in Europe has meant cuts to the healthcare budget, with a major focus on the medicines budget, which has hit its revenues on the continent for the past five years.

Many countries have also been failing to pay their drug bills, including more recently Greece and Italy, with other countries such as Germany introducing draconian new policies such as the AMNOG law to help cut the costs of new medicines.

In November, President Juncker unveiled a new €315bn plan to help resuscitate Europe's economy, a fund that will be built on just €21bn in EU seed money, and therefore will rely heavily on financial engineering to mobilise private investment, such as that from pharma.

An economic boost could help appease anxious companies who are seeing their margins shrink on poor sales in Europe, but the industry will still want more financial security before committing to greater investment.

One of the ways pharma hopes this will happen is from the new - but controversial - Transatlantic Trade and Investment Partnership (TTIP).

In a nutshell, TTIP aims to allow free trade between Europe and the US and potentially lower the regulatory (and thus financial) barriers between the two continents.

The deal is not yet done with both regulatory issues and tariff negotiations still to be had, but this could open up a trade pact between two major economies that house 600 million of the richest consumers in the world. The two markets also made nearly $16tn worth of goods and services in 2012.

Timothy Cook, Lilly's vice president of oncology international, believes this deal could help bring not just economic benefits, but also more drugs to patients in the EU.

He says that the industry recommends a 'pharmaceuticals annex' to TTIP similar to the one included in both the US and EU trade agreements with Korea.

“Such an annex would enshrine principles that reward innovation and promote fair, predictable and transparent processes for deciding which medicines patients can have access to,” he argues.

“Certainly the biopharmaceuticals industry would benefit from a TTIP focused on these areas. But so would its hundreds of thousands of employees and suppliers in the EU. So would the cities and regions in which it operates. So would the universities, research hospitals, and other partners with whom it collaborates. And most of all so would patients benefit.”

As a company with its HQ in the US but a major presence in Europe, the company will naturally be a key winner in any TTIP deal.

But there are concerns that the TTIP will water down food and drug regulations, meaning new medicines could be entering the EU under the deal which are not meeting strict European standards.

Speaking to MEPs at the European Parliament in November, Dr Andriukaitis assured them that safety standards would not be lowered as a result of negotiations over the TTIP.

“As a doctor, I will say no to any attempt to lower EU standards. One cannot compromise on that. These standards shall not be sacrificed for free trade. The high EU standards have also facilitated our global exports,” Dr Andriukaitis said.

Article by
Ben Adams

is a health and life sciences writer

19th January 2015

From: Sales, Regulatory, Healthcare



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