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Can Pharma Reign in Spain? – Part 3

Spain Posted on: 23 Dec 03


The growth of the pharmaceutical market and an improvement in the conditions for R&D, have led to increased emphasis being placed on Spain by pharmaceutical companies. Measures have also been taken by the Spanish government to directly boost pharmaceutical R&D innovation.
Greater clinical research in Spain

In the past, pharmaceutical companies often regarded Spain as bureaucratic when it came to running clinical trials. Partly this was due to sponsors having to deal with three distinct bodies, Ethics Committees, Hospital Administrations and the “Agencia Española del Medicamento” (AEM), when setting up trials (1). The delays involved dissuaded certain sponsors from investing in clinical development in the country. However, in recent times there has been a great improvement in the time to approval due to a simplification in the Spanish submission process (1).

Those with experience in running clinical trials in Spain believe that it has a large potential clinical trial population and an extensive pool of enthusiastic and highly qualified investigators (1).  Therefore, as well as setting up production facilities and laboratories, pharmaceutical companies are also running an increasing number of clinical trials as part of their R&D commitments in Spain (1). Farmaindustria reports that in 1999, nearly 48% of pharmaceutical R&D expenditure in Spain was devoted to clinical trials (2). In 1994, the number of clinical trials in Spain was around 330, but by 2000 this had risen to over 570, reflecting the improving conditions for clinical drug development (1).

The EU Clinical Trials Directive should further improve the conditions for clinical development in Spain as the Directive is intended to standardise conditions for clinical trials across the EU. However, key to successful clinical development in Spain is previous experience of running trials in the country or a partnership with an organisation that is familiar with the local conditions. Companies which do not have a presence in Spain have often been the least successful when running local clinical studies as they find it difficult to cope with the array of specific national procedures involved (1). In contrast, those that have been most successful have been the multi-national firms who have run many studies over the years and put full trust for study set-up with the local affiliate or have used the services of a contract research organisation (CRO) (1). Companies with limited clinical experience in the EU, will find that such situations exist in other EU Member States and so should not be put off by the initial complexity of local procedures in Spain. Taking account of the conditions upfront and following the local guidelines will allow sponsors to gain the advantages for clinical development offered by Spain in terms of research excellence and investigator and patient participation.

Encouraging pharmaceutical R&D in Spain

Although the Spanish government has tried to reduce healthcare expenditure through cost containment policies it understands the growing importance of the pharmaceutical industry to the economy and has thus also taken steps to encourage its viability. Since 1990, there has been a steady shifting of pharmaceutical R&D investment out of Europe to the USA and this has been a worry for both European politicians and those in the European pharmaceutical industry (3). The UK has managed to maintain its level of pharmaceutical R&D investment through the setting up of schemes that benefit organisations investing in R&D and Spain has attempted to follow a similar path (3, 4).

Specifically, the Spanish government has encouraged companies to invest in local R&D through its National Pharmaceutical Program Scheme (4). The first of these (Farma I) was started in 1986 and was followed in successive years by Farma II (1991 - 1993), Farma III (1994 – 1997) and Farma IV (1998 – 2000).

The most recent public programme, Profarma, which ran from 1998 to 2000, set four goals to support innovation in the pharmaceutical sector (4). Namely these were:

  • R&D expenditure as a percentage of ethical drug sales should reach 8%
  • R&D investment and expenditure should rise to €312 million
  • There should be at least 3,000 employees in R&D roles
  • The pharmaceutical trade balance should be improved

Companies that participated in the scheme were evaluated in line with these objectives and were assigned a grading. The grading had important implications as it potentially translated into financial support through direct subsidies or zero interest loans (4). To a degree the Profarma programme was successful as it involved 56 pharmaceutical companies, whose product sales represented 85% of the Spanish market (4). Although financial support was possible as a result of the grading system used, it has been argued that the main benefit from the scheme was in terms of enhancing company reputation, which was helpful for when products were undergoing regulatory and pricing approval (4).


The growth of the pharmaceutical market and an improvement in the conditions for R&D, have led to increased emphasis being placed on Spain by international and national pharmaceutical companies. A series of measures have also been taken by the Spanish government to directly boost pharmaceutical R&D innovation and this has further encouraged company investment in the country. The availability of a highly educated workforce, an improvement in the conditions and opportunities for clinical research and Spain’s strategic location in Europe means that it will remain a key region for the pharmaceutical industry in the future.

Dr Faiz Kermani

Last updated on: 27/08/2010 11:40:18

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