19/01/2015
Julio Sanchez Fierro, vice-president of the Spanish Association of Health Law
The pharmaceutical industry is undergoing a radical change driven by the growing weight of biological drugs. From conventional medicines, of chemical origin and simple molecular structure, we are now moving into a new era featuring drugs of organic origin, complex structure and capable of producing very precise therapeutic targets against prior incurable and fatal diseases. These medicines are the result of strong investments in research and demand time and numerous clinical trials for quality, safety and efficacy.
Facilitating patient access to biological drugs has become a priority in health policy. However, their price is usually high due to the large investments required. But ‘high price’ does not mean ‘high cost’ for the health system, since the use of biological drugs prevents or reduces costs resulting from hospital admissions and re-admissions or the use of ineffective drugs. In any case, the price of biological medicines will decrease due to competition between pharmaceutical companies and the authorisation of the so-called biosimilars (when the original drugs lose their patent). Recent experiences speak for themselves.
From a legal point of view, our pharmaceutical legislation is insufficient for biological drugs, and this is not surprising since it is basically designed for chemical drugs. We therefore need a new regulatory framework that eliminates uncertainty for patients, health professionals, health authorities and pharmaceutical companies.
In order to decide when these drugs are interchangeable and/or replaceable, some specific rules are needed. As acknowledged by Law 10/2013 on pharmacovigilance (article 86.5). To this end it would be appropriate, similar to what is already being done in France, to create a working group comprising physicians, pharmacists, patients and pharmaceutical companies. This Working Group could advance proposals shedding light and certainty on the availability and proper use of biological medicines, which are one of the best hopes for patients.