On Thalidomide Tragedy and the duty to compensate victims

To prevent, to detect and assessing adverse reactions from drugs is subject to the rules of pharmacovigilance. The 2010/84 directive sets the rules that govern the European Union, being the European Medicines Agency, in coordination with the health authorities of the States members, responsible for ensuring the Community dimension of the surveillance. The reciprocal recognition and the existence of a large market whose solvency largely depends on State health services, is allowing a drug to be distributed in another country and recover their development costs. The protection of public health justifies this delimitation of the principle of free enterprise in a market economy, which offers us a reasonable peace of mind in the consumption of drugs.

It has not always been so. The lack of enough safeguards in Europe caused the so-called catastrophe of thalidomide, active principle of the drug that patented the German company Grunenthal and with different denominations, was marketed as a sedative to alleviate nausea and dizziness of pregnant women between October 1957 and, at least, May 1962. Germany, when were confirmed congenital malformations in fetuses that if survived, they did so with irreversible consequences in the hands and feet, withdrew the drug in twelve days. Lack of a central European authority made that six months more passed before that order was given in Spain and it is possible that some years until no longer administered.

The German public Foundation Contergan, name of the drug in that country, was created in 1972 to take care of victims www.contergan.grunenthal.info has distributed more than 600 million euros, 108 provided by the company between 1972 and 2009.

In Spain, in development of the 2010 State general budget law, the Royal Decree 1006/2010 established aid depending on the degree of disability, as an expression of solidarity and support to those affected to try to compensate, to the extent possible, the difficulties that these sequels bring them.

At the same time, a lawsuit brought by the Association of affected (AVITE) http:www.avite.org obtained judgment partially favorable, in November 2013, from the Court of first instance number 90 in Madrid, which condemned to indemnify people affected by Thalidomide, after a diagnosis of the Instituto de Salud Carlos III.

On the occasion of the inauguration of a monument in memory of the victims, in August 2012, in Stolberg, Rhineland, the company expressed its deep regret for what happened. She asked forgiveness for his long silence for nearly 50 years and said that they had learned how important was entering in an open dialogue with those affected and listen to them. However, appealed against the first instance Court judgment before the Provincial Court of Madrid which, in October 2014, revoked it as considered that the legal action to claim had prescribed. The company released a statement in which it indicated that the allegations of the plaintiffs had not been proven. It reiterated that all those affected still have the right to receive the same benefits of the Contergan Foundation, which grants pension annuities to all victims of Thalidomide from Grünenthal products or its distributors and stated that the decision on aid granting is up to an independent expert committee appointed by the Foundation, which depends only on the German Government.

Still pending the judgment of the Supreme Court in a cassation appeal lodged by AVITE, I think that our Government should make diplomatic efforts, if necessary together with other Governments of States with affected citizens in the defense of an equitable compensation for the Spanish victims. If the German Government brought its concerns to the Spanish authorities on the threat of demolition of buildings owned by its own nationals in the line coast, which like all in the same situation have been legalized through the reform of the coastal Act, in the same way the Spanish Government should seek to obtain from the Contergan Committee to recognize as their own, the diagnosis of affected by Thalidomide provided by the Spanish health services. If a greater number of recognized  people it must give way to a new contribution to the Foundation from the company, it is something that is up to her consideration.

Enric R.Bartlett Castellà. Professor ESADE Law School (Univ. Ramon Llull)

The original of this article was published in Spanish in “Directivos y Empresas” April 2015

Administrativo, Derechos Humanos, Máster en Abogacía, Regulatorio | , ,