Pharmaceutical Crime and E-Commerce: a Portuguese Overview

On May 12, 2016June 10, 2016 By officialblogunioIn CommentsLeave a comment

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by João Fidalgo Jorge, Lawyer and Collaborating Member of CEDU

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In 2003, the European Court of Justice declared that a comprehensive ban on the mail-order sales of freely available pharmaceuticals was contrary to European Law (Case C-322/01, 11 December 2003 – the so called “Doc Morris decision”). In reaction to this decision, the German parliament went beyond the court’s ruling, and the Statutory Health Insurance Modernization Act 2004 (“GKV-Modernisierungsgesetz vom 01.01.2004”) opened the door to mail-order and online sales of prescription drugs as well. Some 10 years later, the Research Project on Internet Commerce and Pharmaceutical Crime (ALPhA – http://www.alpha.uni-osnabrueck.de) was born in Osnabrück, under the coordination of Prof. Dr. Arndt Sinn: part of the research programme of the German Federal Ministry for Education and Research (BMBF) on public safety, this joint project is funded by the “Public Safety and White-Collar Crime” branch of the programme. The project builds on the ministry’s stated aim of using the results of the research programme to preserve and increase public safety in the face of increasing white-collar crime without compromising the principles of the rule of law.

In Portugal, the Doc Morris decision effects generated some legal and policy discussions on the subject. This reaction ultimately led to new legislation which provides that retail pharmacies (and similar sales points) may now provide the remote selling of medicines, through their websites – even to consumers currently living in other member states of the European Union, under the conditions laid down on Article 9-A of the Decreto-Lei nº 307/2007 (from 31/08). The use of an electronic website depends on prior notification to the National Institute of Pharmacy and Pharmaceuticals (INFARMED), which created and is responsible for the management of an official list of all licensed Internet pharmacies. The INFARMED then monitors the Internet presence of pharmacies engaged in remote selling, in collaboration with the pharmacies themselves and also other entities (such as the criminal police), according to Articles 9-A and 45 of the mentioned DL 307/2007 – as well as the rules established by the Portaria nº 1427/2007, from 02/11.

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EU finance rules – changes in the horizon

On May 5, 2016June 10, 2016 By officialblogunioIn NewsLeave a comment

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by Joaquim Rocha, Professor at the Law School of University of Minho

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The rules of the Stability and Growth Pact (SGP) for the European Union may yet again undergo some changes. The SGP — whose first version started being implemented in 1997 and since day one has been criticised for vagueness, complexity and juridical fragility — has gone through several amendments seeking to avoid infractions and deviations. Most recent revisions were related to excessive deficit situations into which a number of Member States have been dragged (including Portugal). Following political blockages and negotiation impasses, those revisions were taken to an “extra-Union” solution (conventional/classic international law) via the so-called Treaty on Stability, Coordination and Governance in the Economic and Monetary Union.

At this time, a solution within the EU law framework is pursued. The idea aims to simplify the rules and make them easily manageable by policymakers, public authorities, politicians in general, namely those accountable in the finances. The major line of action revolves around the introduction of a public expenditure’s control index. Simply put, the goal of the financial mechanisms would be transferred from cutting deficit in general to imposing an expenditure limit to the States, which could not override the growth rates of the economy in the mid-term.

It should be a virtuous solution as the fiscal focus has been kept on income, loans and taxes for too long, mistakenly discrediting and setting aside the essential cornerstone of finances: the expenditure.

According to the President of the Eurogroup, Jeroen Dijsselbloem, “We did not discuss how to change the Pact, just how to choose the indicators to assess the compliance with the Pact. (…) It is directly in the hands of finance ministers. It gives us more guidance in the process of designing the budget. It says in advance what you have to do, and you have the control in your hands. There was general agreement that we need an indicator that takes out all the cyclical elements and one-offs but preferably it should be more stable and not change all the time, and we could put more emphasis on indicators that we can actually directly influence as finance ministers“, via Reuters.

On the matter, the Vice President of the European Commission officially addressed after the informal ECOFIN:

“Our intention is to focus more on what is really in the hands of the Ministers of Finance, namely the evolution of primary expenditure and new revenue measures. This does not mean that we will put aside the deficit and the debt objectives. It is rather about making it clear what governments are expected to do to achieve these objectives. There was I would say broad support to pursue the work in this direction.(…) At the same time, we need to be realistic in our expectations, as many underlined that there is no perfect method of calculating the out-put gap, it will always be an approximation“, via European Commission Press Release.

The changes had been anticipated:

EU to consider single “expenditure rule” to cut through budget morass, via Reuters.

Picture credits: Money Scales by Images Money.

A realpolitik, inside view of the Social Security negotiations in the EU on “Brexit”

On May 4, 2016May 6, 2016 By officialblogunioIn CommentsLeave a comment

by Elisabete Silveira, Director of Negotiation and Coordination of International Instruments Unit of Directorate-General of Social Security in Portugal

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After long and difficult discussions, the Heads of State or Government, meeting within the European Council of 18-19 February 2016, adopted a Decision concerning a New Settlement for the United Kingdom within the European Union.

It will become effective on the date the United Kingdom informs the Council about its decision to remain a member of the EU and will require secondary legislation which the Commission will only propose after a successful referendum. Should the result of the referendum in the UK be for it to leave the EU, the set of arrangements agreed by the European Council will cease to exist.

The Decision covers four sections: Economic Governance, Competitiveness, Sovereignty and Social Benefits and Free Movement.

Focusing only on the last section, it should be noted that, following the taking effect of the Decision, the Commission will submit proposals for amending two important Regulations: Regulation (EC) N.º 883/2004 on coordination of social security schemes and Regulation (EU) N.º 492/2011 on freedom of movement for workers within the EU.

The amendment of Regulation (EC) N.º 883/2004 is intended to give Member States, as regards the “exportation of child benefits to a Member State other than that where the worker resides, an option to index such benefits to the conditions of the Member State where the child resides. This should apply only to new claims made by EU workers in the host Member State. However, as from 1 January 2020, all Member States may extend indexation to existing claims to child benefits already exported by EU workers. The Commission does not intend to propose that the future system of optional indexation of child benefits be extended to other types of exportable benefits, such as old-age pensions.”

These arrangements raise many doubts and perplexities.

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Editorial of May 2016

On May 2, 2016June 10, 2016 By officialblogunioIn EditorialsLeave a comment

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by Pedro Madeira Froufe, Editor
and Joana Covelo de Abreu, Junior Editor

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Competition, Public Procurement and Citizenship

Last 18^th April 2016, the transposition deadline for new public procurement Directives passed: Directives 2014/23/EU, 2014/24/EU and 2014/25/EU. The first one deals with the award of the concession contracts and the latter have to do, respectively, with public procurement (and repealing Directive 2004/18/CE) and procurement by entities operating in the water, energy, transport and postal services sectors (repealing, for that matter, Directive 2004/17/CE).

Public procurement has a fundamental role in the European Union, namely in the EUROPE 2020 Strategy context, since it appears as an internal market instrument that is adequate to promote a sustainable development, an intelligent and inclusive growth, aiming, equally, a more reasonable use of public funding. Besides, public procurement regulation, in the European context, always prosecutes competition’s preservation and reinforcement – the background where internal market edification was set.

With those new Directives, there were some aspects of the previous regime that were revised, namely the European thresholds (which define the scope of application of European rules on public procurement). Those were supposed to be updated every two years if necessary. Still, a new proceeding was created: the innovation partnership established between the contracting entity and the participants, which allows setting successive stages and intermediate objectives. E-procurement gains a more relevant role.

According to information provided by European Institutions, public procurement contracts have a significant weight in Member-States economies, representing about 16% of the Union’s GDP. But before public procurement had been regulated by the European Union, only 2% of economic operators that had won public contracts were non-national companies. In this perspective, application of Internal Market rules (namely freedom to provide services and free competition) allowed a better usage of public resources and a better and more fruitful competition, demanding economic operators in the European context to improve their services and to provide them to a lower price (to a more competitive price). With public procurement Europeanization there was also a reinforcement of transparency and equality principles’ respect and a diminishing of fraud and corruption’s risk.

As stated, competition policy always ends up to be in the base (even when indirectly) of the functioning dynamic’s type that we aim to the Internal Market and to the economic integration. Besides, to a large degree, the creation of a competition culture in Europe is the result of integration. Actual challenges are connected, in a great extent, by the balanced markets’ regulation, by the implementation of an economy that is always competitive but also socially aware. New technologies set today new realities not always easy to ordain, safeguarding, in a balanced way, economic efficiency (more competition) and what we can call, in a detailed way, common interest manifestation (and, therefore, of a socially balanced regulation). In the “common economy” field, difficulties of that balance are particularly evident and immediate. Let’s consider an illustrative example: the tension between a (very closely) regulated sector of providing services – taxi services – and the emergence, also in Europe and with great success, of the UBER phenomenon. This is something to follow with interest. It is also a challenge to the densification of European citizenship (economic, directly connected to European consumers).

Picture credits: Numbers and Finance by Reynermedia.

Comment on “La nueva relación entre el Estado y la sociedad”, by José Esteve Pardo

On April 29, 2016June 10, 2016 By officialblogunioIn ReviewsLeave a comment

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by Agustín Ruiz Robledo, Professor at Universidad de Granada

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Review on the book “La nueva relación entre el Estado y la sociedad”, by José Esteve Pardo, Ed. Martial Pons, Madrid, 2013.

The economic crisis has been studied almost from the moment it broke in front of European’s faces in 2008, a time in which many of us thought that the crisis was a purely American matter. Without intending to be very precise, we could say that this broad collective reflection has produced a specialization among economists, who analyse the causes, and lawyers, who focus on the consequences that the crisis is having on our system. However, José Esteve Pardo, Professor of Administrative Law at the University of Barcelona, has broken this pattern to try an approach to the background of the crisis, a crisis that he considers to be of all European states and not just one in particular. In his thesis, as he advances in the title, he considers that the balance between society and State which was gained in the Occidental world after World War II has been broken. This telluric movement, or “fault” as the author calls it, derives in economic problems, terrible unemployment figures, rampant corruption, etc.

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Summary of Tetra Pak – T-51/89

On April 21, 2016April 21, 2016 By officialblogunioIn Summaries of judgmentsLeave a comment

by José Ricardo Sousa, student of the Master's degree in EU Law of UMinho

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Keywords: Common Market, Abuse, Dominant Position, European Commission, Exemption.

Court: CJEU, General Court | Date: June 10th 1990 | Case: T-51/89 | Applicants: Tetra Pak Raussing S.A. vs European Commission

Summary: On 26th July 1988, European Commission declared that Tetra Pak Raussing S.A. was in breach of article 86 of the EEC Treaty because by purchasing LiquiPak, they would have access to LiquiPak’s exclusivity contract of patent. This exclusive licence relates to a new UHT milk-packaging process. On 26th June 1986, EloPak made a complaint to the European Commission contesting TetraPak act according to articles 85 and 86 of the EEC Treaty. European Commission concluded that TetraPak infringed article 86 of the EEC Treaty by abusing its dominant position. TetraPak contested the decision and appealed to First Instance Court based on the argument that European Commission couldn’t disallow the deal based on article 86 when this deal is an exemption to n.3 of article 85 of the EEC Treaty. This argument is separated in three sub-categories:

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An overview of the treatment contract in the DCFR

On April 14, 2016April 14, 2016 By officialblogunioIn EssaysLeave a comment

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by Helga Fonseca, Collaborating Member of CEDU

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INTRODUCTION

The Treatment contract is one of the legal instruments provided in the Draft Common Frame of Reference (DCFR)[i] which allows the parts into a medical services contract under the Art. I.V.C.-8:101 to 8:111.

This particular instrument developed in the 1980s in the legislation of the European Community – now the European Union – has the purpose to protect the parts, inter alia, the consumers in private contractual situations, above all, when one party is in a weaker position (the patient) in comparison to the medical provider (the Services Directive does not applies to the medical services)[ii].

As it says in the DCFR, the “DCFR is developed on the basis of comparative studies of community law and the laws of the Member States, it has to reflect the underlying values to be found in the existing laws, that are not the same in each system”. As far as there are differences between the underlying values in individual jurisdictions, or between the laws of the Member States and EC law, the DCFR mediates between them and takes a balanced position. Any attempt to work in principles of private law, will at least have to deal with the following core aims and the values expressed in them: Justice; Freedom; Protection of Human Rights; Economic welfare; Solidarity and Social Responsibility; Promotion of the Internal Market; Preservations of Cultural and Linguistic Plurality and so on[iii].

The DCFR is to be interpreted and applied in consistent with the aims and principles of which not only the laws of the Member States, but also the principles to which the European Union is based on. Such as the Internal Market with free and fair competitions and free movements of goods, people, services and capital, and the protection of consumers and others in need of protection.

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Summary of Brasserie du Pêcheur & Factortame – C-46/93 and C-48/93

On April 13, 2016April 21, 2016 By officialblogunioIn Summaries of judgmentsLeave a comment

by José Ricardo Sousa, student of the Master's degree in EU Law of UMinho

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Keywords: liability of the state; legislator; claims; repair; individual’s rights

Court: CJEU | Date: March 5th 1996 | Cases: C46/93 and C-48/93 | Applicants: Brasserie du Pêcheur vs Federal Republic of Germany

Summary: This judgment contains two similar cases connected to the same matter: liability of the State.

In the first case, the French company Brasserie du Pêcheur was obliged to cease their exportations from Germany due to German authorithies’ allegations that the beer did not fulfill purity requirement. European Comission interfered in this case and stated that this provisions were contrary to article 30 of EEC Treaty and brought an infringement proceedings against German Federal Republic. On 12th March 1987, the court confirmed EC’s arguments and consequently condemned the German act. Therefore, Brasserie du Pêcheur moves another action to reclaim their losses. The Court had doubts related to the limits of liability of the State and internal law and so they decided to send a question to the CJEU.

In the second case, Factortame intented an action in High Court of Justice with the purpose to challenge the compatibility of Part II of the Merchant Shipping Act with article 52 of the EEC Treaty. This law predicted a new register for British fishing boats and it pretended to obligate vessel’s registration, including those already registered, according to some conditions relating to nationality. The boats that couldn’t be registered were forbidden to fish. In another previous judgement, CJEU considered that this law was contrary to Communitary law, but it was not contrary that all the boats in UK suffered more controled by the authorities. On 4th August 1989, European Comission brought infringement proceedings against UK to suspend nationality requests because they were contrary to articles 7, 52 and 221 of the EEC Treaty. Afterwards, the Court decided to call the intervenients to show the amount of claims, however the Court had doubts in what refers to include a claim for inconstitutional behaviour and send a question to CJEU.

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Editorial of April 2016

On April 7, 2016June 10, 2016 By officialblogunioIn EditorialsLeave a comment

by Emília Castro, Researcher at Faculty of Law, Universität Hamburg

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The EU-Turkey deal and the migration crisis – or how far refugees are from an equal and dignified treatment

The ever-increasing flow of people around the globe is an unarguable consequence of the globalization process, which we have undergone, mainly as of the twentieth century. However, the world seems to have been drawing its attention to the movement of people around the globe not in the very last century, but mostly in the last two years. The nowadays called “migration crisis” has been showing the international society how difficult it is to struggle against some dire situations some people experience in their home countries.

Mainly because of its strong economy and its tradition of human rights, the European Union has been figuring as the main destination of refugees: more than a million migrants and refugees crossed into Europe in 2015 – and there are no signs these numbers are reducing in 2016.

In March 2016, however, the European Union seemed to have taken a step back on refugees’ Human Rights protection. The EU-Turkey Joint Action Plan was put into practice on March 20^th for the sake of managing the refugee crisis. In a nutshell, some of the main aspects of this deal (called by the EU as “principles”) consider[i]:

1) The return of all new irregular migrants and asylum seekers crossing from Turkey into the Greek islands with the costs covered by the European Union;

2) The resettlement of Syrian nationals: for every irregular Syrian returned from the Greek islands and readmitted by Turkey, another regular Syrian will be resettled to the EU Member States directly from Turkey. In order to achieve this goal, EU Member States should make a sufficient number of resettlement places available.

Some principles of this Joint Action Plan draw Turkey and the EU together. In compensation for the return and resettlement scheme – and apart from the obviously needed disbursement of funds under the Facility for Refugees in Turkey, which will be sped up – the Commission and Member States are working on advancing the accession negotiations with Turkey. Moreover, by the end of April 2016, the European Commission should make a legislative proposal to lift the visa requirements for Turkish citizens who want to enter the EU territory.

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Summary of Costa/ENEL – 6/64

On March 31, 2016 By officialblogunioIn Summaries of judgmentsLeave a comment

by José Ricardo Sousa, student of the Master's degree in EU Law of UMinho

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Keywords: primacy; competition rules; non-discrimination; nationalisation; state aid.

Court: CJEU | Date: July 15th 1964 | Case: 6/64 | Applicants: Faminio Costa vs Ente Nazionale Energica Elettrica

Summary: The Italian Republic nationalized the production and distribution of electric energy. In the middle of the proceedings, Mr Costa, shareholder of an energy company affected by the sector nationalization requested the application of article 177 of EEC Treaty to obtain the interpretation of articles 102, 93, 53 and 37 of the same treaty. To Mr Costa, this nationalization infringed the articles mentioned above. The Giudice Consiliatore decided to send a question to CJEU:

“Having regard to Article 177 of the Treaty of25 March 1957 establishing the EEC, incorporated into Italian law by Law No 1203 of 14 October 1957, and having regard to the allegation that Law No 1643 of6 December 1962 and the presidential decrees issued in execution of that Law (No 1670 of 15 December 1962, No 36 of 4 February 1963, No 138 of25 February 1963 and No 219 of 14 March 1963) infringe Articles 102, 93, 53 and 37 of the aforementioned Treaty, the Court hereby stays the proceedings and orders that a certified copy of the file be transmitted to the Court of Justice of the European Economic Community in Luxembourg.’”

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