New European Regulation on jurisdiction and the recognition and enforcement of judgments
Regulation (EU) No 1215/2012, of 12 of December of 2012, on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters
Capsulas Nº 139
In order to facilitate the free movement of judgments in the EU and to improve access to justice, the European Parliament and Council have enacted on 12 of December of 2012 a new Regulation 1215/2012 on jurisdiction, recognition and enforcement of judgment in civil and commercial matters, which shall apply to legal proceedings instituted from... Read More
The European Union approves new measures in order to refine the working of the pharmacovigilance system
Directive 2012/26/EU and Regulation (EU) number 1027/2012, both of 25 of October, which modify Directive 2001/83/EC and Regulation (EC) number 726/2004
CAPSULAS Nº 138
Background It is well known that in the year 2010 the European Union authorities approved an important package of measures in order to improve the efficiency and coordination of the European pharmacovigilance system. The aim was to rationalize the procedures for the detection and evaluation of adverse effects, to avoid duplication and unnecessary procedures, to... Read More
Green light to the amendment of the Law on Guarantees and rational use of medicinal products and medical devices
Agreement of the Council of Ministers on the draft law introduced by the Minister of Health, Social Services and Equality
CAPSULAS Nº 137
In its meeting of Friday 19 of October the Council of Ministers agreed to give green light to the draft law through which a series of amendments will be made to the current Law 29/2006 on guarantees and rational use of medicinal products and medical devices. Without meaning to be exhaustive, and without prejudice to... Read More
A reflection on the often discussed confidentiality of the proposals of bidders
Report 15/2012, of 19 of September, of the Consultancy Board for Administrative Contracting of the Autonomous Region of Aragon
CAPSULAS Nº 137
On 19 of September of 2012, the Consultancy Board for Administrative Contracting of the Autonomous Region of Aragon (JCC-CAA for its Spanish acronym) issued a report on the confidentiality of the proposals of bidders. Confidentiality versus transparency In its Report the JCC-CAA begins by highlighting the possibility that there may be a conflict between the... Read More
To publicly declare the need of a price increase in a sector can turn out to be costly
Resolution of the Spanish Competition Authority (CNC) of 26 of September of 2012 (Case S/0335/11 CEOE)
CAPSULAS Nº 137
Background In the framework of the International Tourism Fair in Spain of 2011, one of the vice-presidents of the Spanish Confederation of Business Organisations (CEOE for its Spanish acronym) declared the following at a round table: “at the risk that there may be someone in this room with authority to initiate proceedings against me, increase... Read More
The automatic application of the deduction of 7,5% imposed by Royal Decree Law 8/2010 has been questioned
Judgment of the contentious-administrative Court number 8 of Seville, of 6 September 2012
CAPSULAS Nº 136
Background Royal Decree-law 8/2010 was issued in May of 2010. Among other things, it imposes the obligation to apply a deduction of 7,5% to the purchases of some medicinal products starting from 1st of June of 2010. One of the issues that the pharmaceutical industry raised in the hospital market on the occasion of the... Read More
The administration must respect the rules of procedure even in urgent cases
The Judgment of the National High Court of 25 July 2012 annuls a decision of the AEMPS that ordered the cessation of the manufacture of certain medicinal products
CAPSULAS Nº 136
Background In July 2009, during an inspection, the inspectors of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS for its acronym in Spanish) ordered a company to immediately cease the manufacture of certain homeopathic medicinal products. The inspection report stated that the order was based on the serious nature of the irregularities detected,... Read More
“Guidelines” may have an interpretative value, but the judicial criteria will always prevail
Judgment of the ECJ of 6 September 2012, Case C-308/11, Kreussler, on the concept of medicinal product
CAPSULAS Nº 136
On 6 of September, the Court of Justice of the European Union pronounced one more judgment on the concept of medicinal product, on when a product must be considered as such and may only be marketed after having received the appropriate authorization. Fitting certain products in European regulations on medicinal products is a complex issue,... Read More
An exclusivity clause with a duration of more than 5 years may be valid if it does not significantly affect competition
Resolution of the Spanish Competition Authority (CNC) of 30 July 2012 (Case S/369/11 Texaco)
CAPSULAS Nº 136
Disputes among wholesale distributors of fuels and the operators who run service stations have resulted in a number of judgments of the Spanish courts, resolutions of the CNC and the European Commission, and even several interpretative judgments of the ECJ. One of the many issues discussed in such lawsuits is the validity of exclusive supply... Read More
The Court of Justice confirms that pharmacies cannot distribute medicinal products without an authorisation to operate as a wholesaler
Judgment of the Court of Justice of 28 of June of 2012, Case C-7/11, Fabio Caronna
CAPSULAS Nº 135
Background Several Italian pharmacists were reported to their home courts for wholesale distributing medicinal products without possessing the authorisation required under Italian law. Most of the proceedings were discontinued on the ground that a pharmacist already authorised to retail medicinal products was exempt from the obligation to obtain the authorisation required for the wholesale distribution.... Read More