Una nueva oportunidad
EL GLOBAL
Dejamos atrás un año particularmente difícil para el sector, que, desde luego, no nos ha dejado demasiados motivos para volver la vista atrás con añoranza. A los duros ajustes que han tenido que asumir industria y distribución, y a los retrasos en el pago a los proveedores por parte de las administraciones, se ha venido... Read More
Pharmacies may not engage in the wholesale of medicinal products
Royal Decree 782/2013, of 11 October, on the distribution of medicinal products for human use (Official Journal No 251/2013)
CAPSULAS Nº 148
Background On September 2011, the Health Authorities of Cantabria fined a pharmacy upon detecting that such pharmacy had sold medicinal products to a wholesaler on several occasions. The Cantabrian Health Authorities understood that the pharmacy committed a serious administrative infringement by carrying out these sales and, consequently, decided to impose a fine of 30.000 Euros.... Read More
The Department of Health regulates the Internet sale of medicinal products for human use that do not require medical prescription
Royal Decree 870/2013, of 8 of November, regulating the distance sale to general public, through Websites, of medicinal products for human use not subject to medical prescription
CAPSULAS Nº 148
Law 29/2006 limited the Internet sale to the medicinal products that were not subject to a medical prescription, as long as they were supplied by a pharmacy, with the intervention of a pharmacist, after such pharmacist has provided personalized advice and in accordance with the rules applicable to the medicinal products to be sold. The... Read More
The new regulatory framework for the distribution of medicinal product was finally approved
Royal Decree 782/2013, of 11 October, on distribution of medicinal product for human use (Official Journal No 251/2013)
CAPSULAS Nº 148
This new provision, which replaces Royal Decree 2259/1994, seeks to adapt the activity to the new times, regulating the concepts that have emerged in the market, and reinforcing the obligations of the operators regarding pharmacovigilance and fight against the counterfeit of medicinal products. Requirements for the practice of this activity The new regulatory framework will... Read More
Minority shareholder’s right to information: scope and limits to the request of “accounting documents, in a broad sense”
Judgment of the Plenary of the Supreme Court, Civil First Chamber, of 19 September 2013, on shareholder’s right to information
CAPSULAS Nº 148
A minority shareholder of a stock company, holding 25% of its shares, demanded, before the shareholders board was held, exhaustive information about the annual accounts that such company pretended to approve. The company did not offer all the information that he requested and therefore, after the rest of the shareholders approved the accounts, he decided... Read More
La guía de preparación merece una reflexión
EL GLOBAL
El origen de la guía se encuentra en el artículo 7 del Real Decreto-Ley 16/2012, aprobado en abril de 2012 al amparo del artículo 93 de la Constitución, que dice que “en caso de extraordinaria y urgente necesidad, el Gobierno podrá dictar disposiciones legislativas provisionales que tomarán la forma de decretos-leyes”. El mismo real decreto-ley... Read More
El Real Decreto de Precios de los Medicamentos
EL GLOBAL
La semana pasada, la Fundación CEFI tuvo la amabilidad de invitarme a un seminario sobre Contratación Pública de Medicamentos celebrado en Madrid y pedirme una ponencia relativa al futuro real decreto de precios de los medicamentos. Sería ilusorio pretender resumir mi intervención en esta columna, de modo que me limitaré a apuntar algunas ideas de... Read More
Some ideas for the new Royal Decree on prices and public financing of medicines in Spain
Summary of the conference given at the Seminario CEFI on Public Procurement of Medicines held on 12 November 2013
CAPSULAS Nº 147
Now that the publication of the long expected new Royal Decree on pricing and reimbursement of medicines in Spain is near, I was kindly invited by the CEFI Foundation to speak about this matter at a Seminar on Public Procurement of Medicines held in Madrid on 12 November. My speech, which is summarised in this... Read More
CEFI Seminar on public procurement of medicines in Spain
Jordi Faus and Juan Suarez speak about therapeutic equivalence and about the new rules on pricing and reimbursement for medicines in Spain
CEFI, Centro de Estudios para el Fomento de la Investigación, has organized this one day seminar to deal with the most relevant aspects affecting public procurement of medicinal products in Spain. The event has been opened by Maria Alonso Burgaz, General Counsel for Lilly Spain and President of Fundacion CEFI; and by Jose Julian Diaz... Read More
Ley de Garantías y Proyecto RD de precios. Precio seleccionado
Presentation at the CEFI Seminar on Public Procurement of Medicines in Spain
CEFI, Centro de Estudios para el Fomento de la Investigación organized this one day seminar to deal with the most relevant aspects affecting public procurement of medicinal products in Spain. The event was opened by Maria Alonso Burgaz, General Counsel for Lilly Spain and President of Fundacion CEFI; and by Jose Julian Diaz Melguizo, Director... Read More