European Union Law: Council Directive 199X/309 on Defective Medicinal Products - Essay Example

European Union Law The United Kingdom implemented Council Directive 199X/309 on Defective Medicinal Products (the “Directive”) as the Defective Medicinal Products Act 2004 (“the Act”), with effect from 1st March 2004. It should have been implemented by the 31st December 2003. This Directive imposed a liability on a manufacturer of a medicinal product (the “Product”) that causes injury or illness and there is no necessity to establish negligence. Compensation has to provide for pain, suffering and loss of wages past, present and future. Moreover, it is the duty of the manufacturer to establish that the product did not cause the injury or illness. However, the Act excluded liability for loss of wages and required the victim to establish the liability of the manufacturer. The Directive and the Act were to replace the existing national laws of negligence in relation to the Product. In May 2004, Byrd was prescribed a Product, manufactured by Omnia Pharma PLC (“Omnia”) a company registered in England, for relieving stress. After using for two weeks, Byrd developed suppurating psoriasis as a side effect of this product. This led to frequent absence from work and the resultant dismissal from service. Byrd unsuccessfully attempted suicide due to these developments. The Product continues to be covered by UK patents with the result that Omnia has a monopoly on sales of the Product in the UK. 1 A The doctrine of direct effect, which is applicable to individuals as well as institutions, permits individuals to file a case in national courts if an EU Directive is incorrectly implemented by that Member State. Rights under direct effect have to be honoured without any reference to domestic law. As such the doctrine of direct effect is an intrinsic part of the notion of the supremacy of European Law and no discretion is permitted to the Member States or Community institutions. Regulations always have direct effect but Directives obtain direct effect only on the basis of the merits of each case (direct effect , 2006). The Community law provisions require Member States to compensate any loss caused to individuals due to the non – implementation of a Directive. In the case of Francovich and Others v Italy, the ECJ made it clear that in order to make a Member State liable for the damages caused to an individual as a result of non – implementation of a Directive, three conditions must be fulfilled. First, the underlying objective of the Directive is to provide rights to individuals; second, there should be a description of such rights and their scope must be incorporated in the Directive and third, the damage caused should be due to the failure of the state to implement the Directive (Faccini Dori v Recreb Srl). In Duke v. GEC Reliance, the plaintiff, Mrs. Duke, could not invoke the Equal Treatment Directive since her employer was a private individual (Duke v GEC Reliance Ltd). Similarly, in Paola Faccini Dori v. Recreb srl, the Italian Government failed to implement a Directive that bestowed customers with the right to cancel contracts that were negotiated outside the business premises. Dori who had entered into a contract at a railway station could not seek the right of cancellation under the Directive. The Court had refused to apply the notion of direct effect to individual relationships (Faccini Dori v Recreb Srl). Eventually, the ECJ through its decisions made it clear that there were different rights provided to state employees and private employees. It also held that if the Member States had clearly implemented the Directive in their national laws there would be no possibility for such frustrating situations to transpire, which placed the national courts in an embarrassing position. Therefore, in our problem, the Directive is not directly effective against Omnia, since it is a non ­ – governmental organization. 2 A It is mandatory for the Member States to implement the treaty principles and the Union’s legislation and the EU requires national governments of the Member States to adopt and implement the European law in their nations appropriately. If the Member States fail to carry out this task, then the EU will approach the ECJ to take appropriate action against that Member State. As such the Commission refers nearly eighty cases to the ECJ per annum on an average. Government agencies, private or public utilities and firms have to apply EU law provisions at national level (Implementation, 2000). Insufficient power to endorse punitive action by the ECJ and lack of enforcing machinery for its decisions has been the drawback of the earlier EC legislation. The introduction of changes to the preliminary ruling system made it possible to overcome this problem by forcing the national courts to enforce ECJ jurisprudence. The Francovich v Italy case established that the EU law had the right to award damages for breach of the European Union law. In that case, the ECJ had ruled that national courts could require the national governments to pay damages to individuals if the government failed to implement EC Directives in an appropriate manner. The ECJ is empowered to impose fines on Member States in cases of violations and breaches of EU law filed by the Commission or other Member States. Thus, violating the European law attracts penalties and the ECJ became more effective in implementing the EC law (European Court of Justice (ECJ), 2000). Consequently, if the Directives are not properly implemented by the Member States, the national courts could compel the national governments to pay damages to the applicants. This was the judgement given by the ECJ in Francovich v. Italy. 3 A Byrd can rely on the indirect effect against the manufacturer Omnia Pharma PLC, since he cannot take action against the same under the direct effect due to the fact that it was a non – governmental organization. Byrd can sue the company for having lost his job and he can also claim damages for the psychological trauma experienced by him. The doctrine of indirect effect enhances the effectiveness of non – implemented or incorrectly implemented directives, which lack direct effect as per the horizontal limitation. This doctrine has come into existence through Von Colson. The ECJ had held in Von Colson that national courts were required to interpret their law with compliance to the wording and purpose of the directive. In other words they have to interpret the directive duly giving it some effect in spite of the absence of proper domestic implementation (Case 14/83 Von Colson and Kamann v Land Nordrhein-Westfalen). In 1991, the ECJ established the Community law’s general principle with regard to the state liability for damages which resulted due to the breach of its obligations, in the famous Francovich case. The breach involved in this case was the non – implementation of a Directive. The ECJ referred to the general principles of the Treaty and the duty of the ECJ which require it to ensure that the law was observed in the interpretation and application of Article 220 (1) EC (Francovich and Bonifaci & others v. Italy ). 4A In the famous Francovich case, the ECJ found the principle of Member State liability in damages to be inherent in the system of the Treaty and necessary to guarantee the full effect of its provisions. The Court also referred to the general principle of Member State loyalty laid down in Art 10 (1) EC Treaty. In our present problem, the UK Government had not implemented the Directive, within the stipulated time. Moreover, the provisions of the act were not in accordance with what had been specified by the Directive. As per the ruling in Francovich, Byrd can sue the UK Government for the loss caused to him due to the improper implementation of the Directive. Byrd can succeed in a claim for damages against the UK Government relying on the Francovich principle. The European integration process was very active in the early 1980s. It was essential to establish common interest of the EU treaty obligations, legislations and common policies. This process of adopting the common legislation and other requirements reflected the core political interests of Member States and resulted in the emergence of a single market programme. The expansion of the scope of the EU law within the territory of the EU was the consequence of the establishment of various EU institutions. Finally, the European Court of Justice became a major voice in the EU. The unequal sharing of resources among Member States and the differences in national legislations has resulted in some very important ECJ judgments. Moreover, some of these decisions have resulted in repealing national sovereignty (Implementation, 2000). References 1. Case 14/83 Von Colson and Kamann v Land Nordrhein-Westfalen, [1984] ECR 1891. 2. direct effect . (2006). Retrieved May 18, 2007, from In Collins Dictionary of Law: http://www.xreferplus.com/entry/5979635 3. Duke v GEC Reliance Ltd, [1988] AC 618. 4. European Court of Justice (ECJ). (2000). Retrieved May 18, 2007, from In Encyclopedia of the European Union: http://www.xreferplus.com/entry/864566 5. Faccini Dori v Recreb Srl, Case C-91/92 [1994] ECR I-3325. 6. Francovich and Bonifaci & others v. Italy , Case C-6. and C-9/90 [1991] ECR I-5357. 7. Implementation. (2000). Retrieved May 18, 2007, from In Encyclopedia of the European Union: http://www.xreferplus.com/entry/864694 Read More