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THE CHALLENGES OF THE BIOTECHNOLOGY SECTOR IN SPAIN

The biotechnology sector in Spain has experienced an immense development in the past decade, already being the world ninth and European fifth ranked country in scientific production. In 2012 it had an impact on the Spanish GDP of 7,8 % (last known data according to the Spanish National Institute of Statistics – INE- ). Keeping in mind that this indicator did not surpass a 3% of the Spanish GDP in 2008, we can then establish the fast development of this sector, and how Spanish companies are increasingly relying on biotechnology use as a means to innovate and grow in their respective markets.

Other statistics also prove this development, according to the Annual Report of ASEBIO (Spanish Association of Biotechnology Companies)[1]: the employment rate has grown, creating almost 800 new jobs in 2012, the number of companies that declare to perform biotechnology activities has risen to more than 3.000 and the turnover has reached an annual 80.000 million euro. Finally, another note that shows the importance of the sector in Spain is that 2014 has been declared as the “Biotechnology Year in Spain”.

Catalonia is the region where most biotechnology companies are, concentrating almost 20% of all Spanish biotechnology companies, followed by Andalusia (with almost 15%) and the Madrid Community (with 13%). The Autonomous Community has traditionally been the headquarters of numerous biotechnology companies: for example, 50% of all Spanish pharmaceutical companies are located here, including the five biggest companies, including Almirall, Esteve and Ferrer Internacional. Catalonia also leads the statistics on number of newly created companies, followed by Andalusia and Galicia, fast becoming one of the most strategically important regions in the biotechnology sector in Europe.

There are several reasons why Catalonia has become the biotechnology leader region in Spain and one of the most important in Europe, alongside BioTOP in Berlin, One Nucleus in Cambridge (London) or Medicen Paris Region, among others. It has 56 investigation centers with a biotechnology activity, 17 university hospitals, two big infrastructure centers (Barcelona Supercomputing Center[2] and Sincotrón ALBA-CELLS[3]), as well as 12 technology centres and 16 scientific and technology parks, which have greatly favored the setup of new companies and the attraction of investment.

The scientific and technology parks located in Catalonia have been a key factor in the development of the sector and the creation of new companies, as their mission has been to facilitate the step from R+D groups and departments to startups. They also offer common use facilities, which mean an important saving on the initial investment necessary to create a new biotechnology company. The possibility of interaction and synergies between startups, technology centers, big companies and R+D facilities have created a perfect space where to establish new companies and develop as a competitive business.

As a consequence, and if we take a look at the number of funds granted by the European Research Council[4], Catalonia is the destination of more than half of those collected by Spain and it is where more than 29% of the funds bestowed to Spain by the European Seventh Framework Programme[5] are located. Catalonia has also attracted specialized investors, including corporate funds (which right now amount to more than 136 million euro in resources) and investment banking, as well as venture capital funds. Between 2009 and 2013 the venture capital investment has multiplied by five, being one of the most recent examples the venture capital company “Caixa Innvierte BioMed II”, created by the Spanish financial entity “La Caixa” in partnership with the Spanish Economy and Competiveness Ministry and the Catalonian Financial Institute, and which will invest 35 million euro in developing biomedical companies.

However, the access to investment funding continues to be the biggest challenge that the Spanish biotechnology sector has to face in order to continue growing and being competitive within the European market. Much of the startups and small and medium companies that focus their activities in biotechnological R+D depend on public funding to subsist and this has dramatically decreased in the last few years due to the economic crisis: the resources and funding of the Spanish Industrial Technological Development Center (CDTI)[6] and of the Agency of Competitiveness for Companies in Catalonia (ACCIÓ)[7] have decreased more than 50% since 2012.

Another challenge of biotechnology companies is not only the adequate protection of their research results through patents (in 2012 more than 700 patent applications were published and only 294 were authorized), but also the necessity of continuing research and a reformulation of the business models once the patents have expired.

The biotechnology regulatory framework is also a barrier for companies that want to start manufacturing and commercialising the products resulting from their research. The Spanish Medicines Agency and Sanitary Products (AEMPS) and the European Medicines Agency (EMA) are the competent entities in charge of the approval of clinical research, manufacture and commercialisation of cosmetics, medical and sanitary products, while the Spanish Agency for Food Security and Nutrition (AESAN) and the European Food Security Authority (EFSA) are the competent authorities for the authorization of manufacture and commercialisation of functional foods and products which contain genetically modified organisms. All of these institutions require expensive clinical essays as well as bureaucratic procedures that are a hindrance for many small and medium companies due to their costs.

The last two challenges mentioned revert back to the first one mentioned: the difficulty of accessing public and private funds to develop the business is seriously affecting the sector. Therefore, and now that it seems that the worst of the economic crisis is over, it is time for the Administration to address the problem and again gradually increase the public funds destined to R+D and scientific innovation: with only a few exceptions of companies with a turnover of more than 100 million euro, such as Grifols or Almirall, the vast majority of the Spanish biotechnology businesses are small and medium companies that greatly depend on private or public funding for their subsistence and growth.

Last but not least, it is highly necessary to value and commercialise R+D and innovative investigation in order to encourage private investment, promoting a closer collaboration between the public and private sector. The number and funding of universities and public research centres with biotechnological projects has to increase and a sustained commitment by the Government of R+D is imperative if we want to remain competitive, now that the emerging countries such as China or Brazil are slowly becoming firm competitors in the worldwide market. The creation of more public and private entities would without doubt attract private investment, being able in this way to compete with our worldwide equals.

[1] Annual Report of ASEBIO (Spanish Association of Biotechnology Companies) 2013 (www.asebio.com)

[2] Barcelona Supercomputing Center:  www.bsc.es

[3] Sincotrón ALBA-CELLS: www.cells.es

[4] European Research Council (http://erc.europa.eu/)

[5] Seventh Framework Programme of the European Community for Research, technological development and demonstration activities: http://europa.eu/legislation_summaries/energy/european_energy_policy/i23022_en.htm

[6] The Industrial Technological Development Center (CDTI) is a public company dependent on the Spanish Economic and Competiveness Ministry, which promotes the innovation and technological development of Spanish companies (www.cdti.es).

[7] Agency of Competitiveness for Companies in Catalonia (ACCIÓ): http://accio.gencat.cat/