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Spain creates legal uncertainty over biosimilars

01 August 2014 Angelica Kershaw

From a government perspective, the potential benefits of biosimilars are pretty clear: they offer great potential to improve healthcare access through significant cost savings. The benefits to national health systems appear irresistible, especially those with ambitions to cut back on spending. So it was perhaps somewhat surprising that the government in Spain last week published a Ministerial Order that enforces the Royal Decree of Reference Prices and did not take the opportunity to clarify biosimilar regulation in Spain.

Biotherapeutic medicines have over the last couple of decades transformed healthcare services offering innovative treatments for chronic diseases, which were challenging to treat. At the same time, the patent cliff and high costs of reference biotherapeutic medicines have boosted interest in biosimilars. Biosimilars are biological base products with more affordable prices since they are similar (not identical) copies of a biological drug, whose period of patent protection has expired.

The European biosimilars framework (Directives 2003/63/EC and 2004/27/EC) and international legal systems (World Health Organisation and the FDA) establish a clear differentiation between generic and biosimilar medicines, and state that they should be regulated by different rules. Indeed, these regulations make it impossible to treat interchangeability rules for biosimilars in the same ways that those rules regulate generic medicines. Substitutability - which is left to national legislation to address - is also treated differently for biosimilars.

Confusing Spanish landscape The need for specific biosimilars regulation transposing the EU Biosimilar Directives into Spanish law has been highlighted by the pharma industry and some areas of the public administration in Spain. Nonetheless, Spain has not yet introduced a specific regulatory framework for biosimilar products and the few legal references to biosimilars have been inadequate and confusing.

The first piece of legislation that introduced the concept of biosimilars in Spain was the law-decree 16/2012 that in Article 4 incorrectly equates the concepts of generics and biosimilars. Subsequently the law 10/2013 - which came into effect just a few weeks ago - partially corrected this since Article 32 introduces a difference between generics and biosimilars. Indeed it establishes that biosimilars must be subject to a set of special regulatory rules. However, the same piece of legislation in Article 38 again incorrectly regulates prices for biosimilars and generics under the same rules, treating biosimilars as being part of homogeneous groups in the application of the reference-pricing system.

This situation has been strongly criticised by the Spanish pharmaceutical industry. Sánchez Fierro, a board member of the Spanish Health Law Advisory Association, wants legal reform to address the discrepancy as a minimum. Without reform implementing a price system and financing that take into account the special characteristics of biosimilars, a sustainable biosimilar industry in Spain and the benefits it offers to the Spanish national health system will not be realised.

Future requirements The current state of biosimilars regulations in Spain creates uncertainty for pharmaceutical companies in Spain. On the one hand, there are no clear rules requiring substitution: in the absence of those, building a sizeable market share would be difficult. On the other hand, pricing regulations treat biosimilars in the same way as generics - the implicit assumption being that there would be a large market share and economies of scale that would allow manufacturers to lower biosimilars prices.

What the industry, patients and doctors need is the introduction of a special biosimilar regulation that provides clarity and legal certainly in the Spanish biosimilar market. This would provide pharmaceutical and biotechnology companies with legal certainty to invest in the development of biosimilars and would increase health professionals' and patients' confidence in the use and prescribing of biosimilar medicines. As a minimum, reform in the Decree Laws 16/2012 and 10/2013 is needed to rectify the current legal discrepancy. However, if and when steps are taken by Spanish legislators to address the lack of biosimilars regulations, remains to be seen.



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