The president of the Spanish Association of Orphan and Ultra Orphan Drugs(AELMHU), Beatriz Perales, took part this Tuesday in the VI Symposium of the Observatorio de la Sanidad of El Españolto address the position of the sector with respect to the Draft Bill on Medicines and Medical Devices.
She was accompanied at the round table by María Aláez, Technical and Quality Director of Fenin; Elena Casaus, Secretary General of the Spanish Association of Generic Drugs (AESEG); Jaume Pey, Director General of the Association for Self-Care in Health (Anefp); Jordi de Dalmases, Vice-President of the General Council of Pharmaceutical Associations (CGCOF); and Encarna Cruz, Director General of the Spanish Association of Biosimilars (BioSim).
In her remarks, Beatriz Perales noted that the preliminary draft is “a necessary reform” after 10 years without an update to this law, as well as “a good opportunity to continue making progress on many issues of concern to the pharmaceutical industry.”
“The preliminary draft has been a very good opportunity to discuss issues and points of interest that were of concern to the sector. We’ve had the chance to debate them within the sector and with the government, which is a good exercise for the future,” he emphasized.
In this regard, it has applauded the inclusion of some measures proposed by AELMHU during the allegations period, such as the accelerated, conditional and/or provisional incorporation into the pharmaceutical provision of new drugs or authorized indications for unmet medical needs.
However, he also expressed the sector's concern about the new wording of point 4 of the sixth additional provision, which includes hospital drugs for the first time in the scope of application of the company's contributions.
“Our position is that orphan and ultra-orphan drugs should be excluded from this provision in order to provide an incentive for the development, manufacture, and marketing of these drugs,” argued the president of AELMHU.
He also called for the “crucial moment” the pharmaceutical industry is currently experiencing to be taken into account in the final draft of the preliminary bill : “Any legislation proposed regarding medicines must protect and promote innovation in the pharmaceutical sector and, in particular, medicines for rare diseases.”
Finally, Beatriz Perales expressed AELMHU's willingness to collaborate with all the agents involved (patients, healthcare professionals, researchers, industry and public authorities) to make rare diseases a strategic priority within these new legislative initiatives and, above all, to respond to all the needs of patients.