The European Parliament has withdrawn its threat of sanctions on the Innovative Medicines Initiative (IMI), the multibillion public-private partnership on pharmaceutical research that has come under fire for its accounting practices.
Voting during its plenary session in Strasbourg on Wednesday, 402 members of Parliament (MEPs) rejected a motion to postpone approval of the programme’s accounts.
Members of the assembly’s budgetary control committee had this week asked for clearer information on the contribution of drug companies to the research initiative, following recent complaints the programme’s deck is unfairly stacked in their favour.
Set up in an effort to remove the major bottlenecks in drug discovery and development, the €3.3 billion IMI 2 is the biggest public private research programme in Europe. While half of the value of the programme is in hard cash from Horizon 2020 to fund academics and small biotechs, the remainder is in the form of in-kind contributions from pharma companies.
On the industry side IMI is managed by the European Federation of Pharmaceutical Industries and Associations (EFPIA). As the contracting body, EFPIA is responsible for compiling an amalgamated audit of the in-kind contributions made by member companies that take part in IMI.
In a draft presented to the Strasbourg plenary this week, the budgetary control committee called for, “Detailed information on the in-kind contributions of EFPIA [members], especially on the type of the in-kind contributions and their respective value.”
With the initiative’s accounts now cleared, these additional reporting requirements can be shelved, and IMI can shake off the allegation of financial ineptitude.
A statement issued by IMI on Wednesday said it was “extremely pleased” that its accounts received a tick from the Parliament’s budgetary control pen.
It continued, “Nevertheless, IMI takes the concerns raised during the debates seriously. Over the coming weeks, we will carefully review the comments made by MEPs and reflect on how we can draw on them to improve our procedures and reporting in the future.”This is the annual event that sees the Parliament taking stock of EU programme accounts. MEPs begin looking at numbers in November and make their positions known by springtime the following year. The investigation tries to get to the bottom of whether EU money was spent in accordance with the rules, rather than the return on investment.
IMI, a research initiative between the EU and EFPIA, began in 2008 with IMI 1, a €2 billion programme. The successor, IMI 2, has a total budget of €3.3 billion for 2014-24.
Old debates resurface
The threat to censure IMI comes not long after the German current affairs magazine Der Spiegel published the results of a six month investigation of the programme, which concluded that it amounts to a subsidy from the public purse to the pharma industry. In addition, the results achieved by IMI to date have been “disastrous”, Der Spiegel claimed.
The interim executive director of IMI, Irene Norstedt, said, “The story that was told is not what we see on a day to day basis.”“I was surprised by its inaccuracies,” she told Science|Business. “Big pharma pays its own way.”
For anyone keeping an eye on IMI, aspects of the Der Spiegel story had a familiar ring. Going back to the beginning of the initiative, there have been similar complaints that universities, research institutions and small businesses are not treated as equal partners.
A lot has been made of the thorny issue of intellectual property (IP) and arguments over IP have proved a sticking point in agreeing IMI collaborations in the past, with would-be academic partners feeling they were not being treated fairly.
There is no mystery around IP, said Norstedt. “It’s very similar to collaborative research rules [so] I think it’s more of a perception,” she said. “It’s all discussed up front so there’s no surprises going in and we have very good lawyers [to help universities and small business].”
And as for what small business gets from the initiative: some 169 small businesses, mostly biotech companies, have participated in IMI and drawn in around 16 per cent of total IMI funding to date, Norstedt added.
Responding to Ebola
Norstedt is a Commission official who took the wheel of IMI after the European Commission’s human resources department failed to secure a replacement to take over from Michel Goldman, who stepped down in mid-December. Since the start of the year she has had to face up to a slate of new challenges, not least the ongoing Ebola crisis.IMI’s response to the Ebola virus epidemic in West Africa, was a new rhythm for the group, and proves the programme is flexible enough to, “respond rapidly to emerging healthcare emergencies,” says Norstedt.
IMI kicked off its first eight projects on Ebola in mid-January, covering vaccine development and manufacture, clinical trials and storage and transport, with a budget of €215 million.
The lion’s share of the cash is going to a combination vaccine being developed by Johnson & Johnson and Denmark-based biotech company Bavarian Nordic.
Currently no vaccines are available to protect against Ebola but other vaccines developed by Merck & Co and GlaxoSmithKline, are now in phase III trials in infected areas in West Africa. It is too early to say whether any will show a positive effect, said Norstedt.
The IMI Ebola projects were selected from 19 proposals submitted under a call launched only last November. Norstedt said the competitions were deliberately different from IMI’s usual approach, involving only one stage submissions.“Ebola’s been a good showcase for proving we can quickly mobilise funding,” Norstedt added.
New members, directions
Norstedt, who normally helps run the European Commission’s unit for innovative and personalised medicines, is firm on the programme’s goals. “Europe used to be the hub of new pharma in the 70s and 80s,” she said. “But by the 90s, a lot of this moved abroad: our job is to help stimulate the pharma scene and make it more attractive for companies to do research.”
In its first phase from 2008-2013, when its total budget was €2 billion, IMI was active in research for cancer and Alzheimer's among other diseases. In IMI 2, the programme is beginning to branch into new areas and take on board more associate partners. It has, “a more open nature”, Norstedt said.
“Confidence has been growing,” she said. “The scope is broader; the budget is bigger.”
IMI’s most recent call, and its fourth overall since the programme started last year, included a project on whooping cough, to which the Bill & Melinda Gates Foundation is contributing. JDRF, a patient organisation focused on type I diabetes, is investing €2.8 million in new diabetes projects as well as offering its expertise, while Helmsley Trust is putting in €2.2million.
The date for the next round of IMI calls has not yet been announced but information on the topics they will cover is online.
Who will take the controls?
There is little intrigue surrounding IMI’s failure to announce a full-time executive director yet, Norstedt said. Although the job has been posted since June of last year, it is common to move slowly and carefully when hiring for a high-level post, she said.
Norstedt did not want to speculate on who will fill the leadership hole left by Goldman, who has taken up residence as a professor in the Free University of Brussels. “The recruitment is in the hands of the human resources department in the European Commission,” she said.
Is her hat in the ring? “I’m not a candidate,” she replied, saying that she will return to her day job.