Within the past decade, Spain has developed into a top player in the European clinical trial network. The pharmaceutical industry has been increasing its investment commitment in the market and taking advantage of the country’s outstanding public health system.
These activities are being well received by the government, so much so that in December 2015 the Spanish Council of Ministers passed a Royal Decree regulating clinical drug trials and set up the Ethics Committees for Investigation (CEIm), and the Spanish Clinical Studies Registry (REec).
By establishing that clinical trials may be approved with an evaluation and report from just one accredited ethics committee and the Spanish Agency of Medicines and Medical Devices (AEMPS), the decree sought to increase transparency, simplify procedures for clinical trials, and foster public research to cover non-priority areas for the pharmaceutical industry. Furthermore, Spain was the first to apply the most recent European regulations on clinical trials which went into force in May 2016.
In 2016, total R&D investment from the pharmaceutical industry reached EUR 1,085 million, making it the leading R&D industry in Spain with 21 percent of total investments. While today’s expenditure is rather healthy, the narrative was not always so. Looking back, R&D investment took a turn for the worse starting in 2009 at EUR 1,029.8 million until finally hitting rock bottom in 2013 at EUR 921.6 million, a -10.5 percent drop caused by the widespread economic crisis. Nevertheless, the tides turned in Spain and investments have seen an impressive 17.8 percent recovery from 2013 to today.
Of this total R&D spending, Farmaindustria reveals that EUR 557 million is allocated to clinical trials, followed by EUR 150.7 million for basic research, EUR 106 million for post-authorization studies, and EUR 70.4 million for Galenic research.
With clinical trials accounting for nearly half of research expenditure, the 48.12 percent growth in the number of clinical studies conducted in Spain between 1997 and 2016 is unsurprising.
Spain’s strongest clinical research area by far is oncology with an investment rate of 38.6 percent, followed by cardiovascular (8.1 percent), anti-infectives (7.1 percent) and neuroscience (6.7 percent).
Taking the country’s autonomous communities into consideration, the geography of clinical study locations is highly concentrated in Spain’s two principal communities — Madrid and Barcelona. Combined they conduct over half of the studies on a national level, the former at 23.3 percent and the latter at 27.1 percent.
Drawn by the appealing R&D environment, many top tier MNCs have brought their clinical projects to Spain to take advantage of the country’s skilled workforce, quality infrastructure, and favourable policies. Novartis, one of the largest pharmaceutical companies by both market capitalization and sales, has started 64 studies since 2015, giving the MNC a strong lead over Abbvie with 48, BMS with 40, and Roche with 39 studies.
Within Europe, Spain ranks fifth in the number of clinical trials conducted since 2008 at 9,980; after France, Germany, UK, and Italy. However, in terms of clinical studies started in 2017, Spain falls fourth after France, UK, and Germany, having begun 656 trials.
In a global context, Europe has grown healthily in clinical trial investment over the ten years between 1995 and 2015. From EUR 11.5 million invested in 1995 to EUR 33.6 million invested in 2015, financing in Europe has matured by 192 percent compared to 296 percent in the US and 127 percent in Japan during the same timeframe.
As Europe continues to cultivate its innovative ecosystem, we can expect Spain to continue nurturing its research potential and remain as a chief partner of the pharmaceutical industry within the region.
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