62-652: Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions is a European Union directive in the field of patent law, made under the internal market provisions of the Treaty of Rome . It was intended to harmonise the laws of Member States regarding the patentability of biotechnological inventions , including plant varieties (as legally defined) and human genes . The Directive
124-578: A candidate to have a democratic government and free-market economy together with the corresponding freedoms and institutions, and respect for the rule of law . Enlargement of the Union is also contingent upon the consent of all existing members and the candidate's adoption of the existing body of EU law, known as the acquis communautaire . The United Kingdom , which had acceded to the EU's predecessor in 1973, ceased to be an EU member state on 31 January 2020, in
186-520: A directive in theory but has failed to abide by its provisions in practice. If a Member State fails to implement a Directive timely or correctly, the Directive itself becomes binding on the Member States, meaning that parties in proceedings against the state may rely on provisions of the untimely or incorrectly transposed Directive. An example of a case in which the applicant was able to invoke
248-671: A directive. On 13 December 1995, the Commission adopted a new proposal was nearly identical to the rejected version, was changed again, but the Parliament put aside its ethical concerns on patenting of human genes in on 12 July 1998 in its second reading and adopted the Common Position of the Council , so in the second legislative process, the directive was adopted. The drafts person of the Parliament for this second procedure
310-449: A formalisation of the situation. EU integration is not always symmetrical, with some states proceeding with integration ahead of hold-outs. There are several different forms of closer integration both within and outside the EU's normal framework. One mechanism is enhanced cooperation where nine or more states can use EU structures to progress in a field that not all states are willing to partake in. Some states have gained an opt-out in
372-607: A greater or lesser extent. If an aspect is not listed in the table below, then it remains the exclusive competence of the member state. Perhaps the best known example is taxation, which remains a matter of state sovereignty. As a result of the European sovereign debt crisis , some eurozone states were given a bailout from their fellow members via the European Financial Stability Facility and European Financial Stability Mechanism (replaced by
434-528: A member state to leave the bloc. The procedure for a state to leave is outlined in TEU Article 50 which also makes clear that "Any Member State may decide to withdraw from the Union in accordance with its own constitutional requirements". Although it calls for a negotiated withdrawal between the seceding state and the rest of the EU, if no agreement is reached two years after the seceding state notifying of its intention to leave, it would cease to be subject to
496-401: A monarch although political powers are exercised by elected politicians. Most republics and all the monarchies operate a parliamentary system whereby the head of state (president or monarch) has a largely ceremonial role with reserve powers . That means most power is in the hands of what is called in most of those countries the prime minister, who is accountable to the national parliament . Of
558-458: A new country applying from scratch. However, other studies claim internal enlargement is legally viable if, in case of a member state dissolution or secession, the resulting states are all considered successor states . There is also a European Citizens' Initiative that aims at guaranteeing the continuity of rights and obligations of the European citizens belonging to a new state arising from
620-545: A political process known as Brexit . No other member state has withdrawn from the EU and none has been suspended, although some dependent territories or semi-autonomous areas have left . There are a number of overseas member state territories which are legally part of the EU, but have certain exemptions based on their remoteness; see Overseas Countries and Territories Association . These "outermost regions" have partial application of EU law and in some cases are outside of Schengen or
682-574: A sequence or partial sequence of a gene ceases to be part of the human body merely because an identical copy of the sequence is isolated from or produced outside of the human body." TRIPS applies to the European Community as it is a member of the World Trade Organization (WTO) in its own right and accordingly must ensure "the conformity of its laws, regulations and administrative procedures with obligations as provided" by
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#1732779599466744-465: A template for the pro-EU regions of the UK remaining within the EU or its single market. Beyond the formal withdrawal of a member state, there are a number of independence movements such as Catalonia or Flanders which could result in a similar situation to Greenland. Were a territory of a member state to secede but wish to remain in the EU, some scholars claim it would need to reapply to join as if it were
806-546: Is Article 288 of the Treaty on the Functioning of the European Union (formerly Article 249 TEC ). Article 288 To exercise the Union's competences, the institutions shall adopt regulations, directives, decisions, recommendations and opinions. A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States. A directive shall be binding, as to
868-415: Is delegated by each member to the institutions in return for representation within those institutions. This practice is often referred to as 'pooling of sovereignty'. Those institutions are then empowered to make laws and execute them at a European level. If a state fails to comply with the law of the European Union , it may be fined or have funds withdrawn. In contrast to some international organisations,
930-486: Is divided into the following five chapters: The original proposal was adopted by the European Commission in 1988. The procedure for its adoption was slowed down by primarily ethical issues regarding the patentability of living matter. The European Parliament eventually rejected the joint text from the final Conciliation meeting at 3rd reading on 1 March 1995 so the first directive process did not yield
992-463: Is isolated from its natural environment ... may be the subject of an invention even if it previously occurred in nature." It is clearly arguable that merely isolating a human gene or protein from its natural environment is not an activity that can come within the meaning of the word 'invention'. The Danish Council of Bioethics in its Patenting Human Genes and Stem Cells Report noted that "In the members' view, it cannot be said with any reasonableness that
1054-419: Is open to any European country that is a stable, free-market liberal democracy that respects the rule of law and human rights. Furthermore, it has to be willing to accept all the obligations of membership, such as adopting all previously agreed law (the 170,000 pages of acquis communautaire ) and switching to the euro . For a state to join the European Union, the prior approval of all current member states
1116-602: Is presented to the Parliament and the Council —composed of relevant ministers of member governments, initially for evaluation and comment and then subsequently for approval or rejection. There are justifications for using a directive rather than a regulation: (i) it complies with the EU's desire for "subsidiarity" ; (ii) it acknowledges that different member States have different legal systems, legal traditions and legal processes; and (iii) each Member State has leeway to choose its own statutory wording, rather than accepting
1178-512: Is required. In addition to enlargement by adding new countries, the EU can also expand by having territories of member states, which are outside the EU, integrate more closely (for example in respect to the dissolution of the Netherlands Antilles ) or by a territory of a member state which had previously seceded and then rejoined (see withdrawal below). There is no provision to expel a member state, but TEU Article 7 provides for
1240-639: Is superior to State law is subject to some debate. The treaties do not give a judgement on the matter but court judgements have established EU's law superiority over national law and it is affirmed in a declaration attached to the Treaty of Lisbon (the proposed European Constitution would have fully enshrined this). The legal systems of some states also explicitly accept the Court of Justice's interpretation, such as France and Italy, however in Poland it does not override
1302-596: Is taken against it as outlined above. However, the treaties do not provide any mechanism to expel a member state outright. Prior to the Lisbon Treaty , there was no provision or procedure within any of the Treaties of the European Union for a member state to withdraw from the European Union or its predecessor organisations. The Lisbon Treaty changed this and included the first provision and procedure of
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#17327795994661364-413: The Council for the union to adopt some policies; for others, collective decisions are made by qualified majority voting . These obligations and sharing of sovereignty within the EU (sometimes referred to as supranational ) make it unique among international organisations, as it has established its own legal order which by the provisions of the founding treaties is both legally binding and supreme on all
1426-533: The European Stability Mechanism from 2013), but this came with conditions. As a result of the Greek government-debt crisis , Greece accepted a large austerity plan including privatisations and a sell off of state assets in exchange for their bailout. To ensure that Greece complied with the conditions set by the European troika (ECB, IMF, Commission), a 'large-scale technical assistance' from
1488-480: The National Council of Slovenia . All elections in member states use some form of proportional representation . The most common type of proportional representation is the party-list system . There are also differences in the level of self-governance for the sub-regions of a member state. Most states, especially the smaller ones, are unitary states ; meaning all major political power is concentrated at
1550-491: The state's constitution , which it does in Germany. The exact areas where the member states have given legislative competence to the Union are as follows. Every area not mentioned remains with member states. In EU terminology, the term 'competence' means 'authority or responsibility to act'. The table below shows which aspects of governance are exclusively for collective action (through the commission) and which are shared to
1612-457: The Brussels' official " Eurospeak " terminology. For example, while EU Directive 2009/20/EC (which simply requires all vessels visiting EU ports to have P&I cover) could have been a regulation (without requiring member states to implement the directive), the desire for subsidiarity was paramount, so a directive was the chosen vehicle. The legal basis for the enactment of directives
1674-404: The Directive. European Union directive A directive is a legal act of the European Union that requires member states to achieve particular goals without dictating how the member states achieve those goals. A directive's goals have to be made the goals of one or more new or changed national laws by the member states before this legislation applies to individuals residing in
1736-513: The EU VAT area—however they are legally within the EU. They all use the euro as their currency. Abbreviations have been used as a shorthand way of grouping countries by their date of accession. Additionally, other abbreviations have been used to refer to countries which had limited access to the EU labour market . According to the Copenhagen criteria , membership of the European Union
1798-486: The EU's style of integration as a union of states does not "emphasise sovereignty or the separation of domestic and foreign affairs [and it] has become a highly developed system for mutual interference in each other's domestic affairs, right down to beer and sausages.". However, on defence and foreign policy issues (and, pre- Lisbon Treaty , police and judicial matters) less sovereignty is transferred, with issues being dealt with by unanimity and co-operation. Very early on in
1860-697: The European Commission and other member states was deployed to Greek government ministries. Some, including the President of the Euro Group Jean-Claude Juncker , stated that "the sovereignty of Greece will be massively limited." The situation of the bailed out countries (Greece, Portugal and Ireland) has been described as being a ward or protectorate of the EU with some such as the Netherlands calling for
1922-599: The European Court of Justice developed the doctrine of direct effect where unimplemented or badly implemented directives can actually have direct legal force. In the important case of Francovich v. Italy , the ECJ extended the principle of Van Gend en Loos to provide that Member States who failed to implement a directive could incur liability to pay damages to individuals and companies who had been adversely affected by such non-implementation. Member state of
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1984-550: The European Parliament; prospective justices must be confirmed by the existing members. Historically, larger member states were granted an extra Commissioner. However, as the body grew, this right has been removed and each state is represented equally. The six largest states are also granted an Advocates General in the Court of Justice. Finally, the Governing Council of the European Central Bank includes
2046-499: The European Union The European Union (EU) is a political and economic union of 27 member states that are party to the EU's founding treaties , and thereby subject to the privileges and obligations of membership. They have agreed by the treaties to share their own sovereignty through the institutions of the European Union in certain aspects of government. State governments must agree unanimously in
2108-522: The States to Community, the Member States have limited their sovereign rights and have thus created a body of law which binds both their nationals and themselves...The transfer by the States from their domestic legal system to the Community legal system of the rights and obligations arising under the Treaty carries with it a permanent limitation of their sovereign rights. The question of whether Union law
2170-488: The Treaty on European Union While the member states are sovereign, the union partially follows a supranational system for those functions agreed by treaty to be shared. ("Competences not conferred upon the Union in the Treaties remain with the member states"). Previously limited to European Community matters, the practice, known as the ' community method ', is currently used in many areas of policy. Combined sovereignty
2232-404: The UK eventually withdrew from the EU on 31 January 2020. Prior to 2016, no member state had voted to withdraw. However, French Algeria , Greenland and Saint-Barthélemy did cease being part of the EU (or its predecessor) in 1962, 1985, and 2012, respectively, due to status changes. The situation of Greenland being outside the EU while still subject to an EU member state had been discussed as
2294-470: The WTO. On 14 January 2002, the Commission submitted an assessment of the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable as required under Article 16(b) of this directive. According to SmithKline Beecham lobbyist Simon Gentry, the company allocated 30 million ECU for a pro-Directive campaign. Part of this campaign
2356-526: The adoption of the directive with six different pleas but the Court granted none of them. Nevertheless, the ECJ decision does not preclude a further test of the validity of the directive on the ground that it is inconsistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Art. 27.1 TRIPS provides that patents are only to be granted with respect to 'inventions'. The directive, however, provides that "biological material which
2418-437: The appropriate legislative procedure, both institutions can seek to make laws. There are Council directives and Commission directives. Article 288 does not clearly distinguish between legislative acts and administrative acts, as is normally done in national legal systems. Directives are binding only on the member states to whom they are addressed, which can be just one member state or a group of them. In general, however, with
2480-403: The democratic secession of a European Union member state. Each state has representation in the institutions of the European Union . Full membership gives the government of a member state a seat in the Council of the European Union and European Council . When decisions are not being taken by consensus , qualified majority voting (which requires majorities both of the number of states and of
2542-488: The directive to be implemented correctly. This is done in approximately 99% of the cases. If a member state fails to pass the required national legislation, or if the national legislation does not adequately comply with the requirements of the directive, the European Commission may initiate legal action against the member state in the European Court of Justice . This may also happen when a member state has transposed
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2604-527: The directly elected lower house and require its support to stay in office—the exception being Cyprus with its presidential system. Upper houses are composed differently in different member states: it can be directly elected like the Polish senate ; indirectly elected, for example, by regional legislatures like the Federal Council of Austria ; or unelected, but representing certain interest groups like
2666-583: The exception of directives related to the Common Agricultural Policy , directives are addressed to all member states. When adopted, directives give member states a timetable for the implementation of the intended outcome. Occasionally, the laws of a member state may already comply with this outcome, and the state involved would be required only to keep its laws in place. More commonly, member states are required to make changes to their laws (commonly referred to as transposition ) in order for
2728-555: The founding treaties from participating in certain policy areas. The admission of a new state the Union is limited to liberal democracies and Freedom House ranks all EU states as being totally free electoral democracies. All but 4 are ranked at the top 1.0 rating. However, the exact political system of a state is not limited, with each state having its own system based on its historical evolution. More than half of member states—16 out of 27—are parliamentary republics , while six states are constitutional monarchies , meaning they have
2790-428: The governors of the national central banks (who may or may not be government appointed) of each euro area country. The larger states traditionally carry more weight in negotiations, however smaller states can be effective impartial mediators and citizens of smaller states are often appointed to sensitive top posts to avoid competition between the larger states. This, together with the disproportionate representation of
2852-415: The history of the EU, the unique state of its establishment and pooling of sovereignty was emphasised by the Court of Justice: By creating a Community of unlimited duration, having its own institutions, its own personality, its own legal capacity and capacity of representation on the international plane and, more particularly, real powers stemming from a limitation of sovereignty or a transfer of powers from
2914-409: The interests of all the member states within the EU. In the 1950s, six core states founded the EU's predecessor European Communities ( Belgium , France , Italy , Luxembourg , the Netherlands , and West Germany ). The remaining states have acceded in subsequent enlargements . To accede, a state must fulfil the economic and political requirements known as the Copenhagen criteria , which require
2976-545: The larger ones). The members of the European Parliament have been elected by universal suffrage since 1979 (before that, they were seconded from national parliaments ). The national governments appoint one member each to the European Commission , the European Court of Justice and the European Court of Auditors . Prospective Commissioners must be confirmed both by the President of the Commission and by
3038-403: The member states (after a landmark ruling of the ECJ in 1964 ). A founding principle of the union is subsidiarity , meaning that decisions are taken collectively if and only if they cannot realistically be taken individually. Each member country appoints to the European Commission a European commissioner . The commissioners do not represent their member state, but instead work collectively in
3100-503: The member states. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. Directives can be adopted by means of a variety of legislative procedures depending on their subject matter. The text of a draft directive (if subject to the co-decision process, as contentious matters usually are) is prepared by the Commission after consultation with its own and national experts. The draft
3162-469: The national level. 9 states allocate power to more local levels of government. Austria, Belgium and Germany are full federations, meaning their regions have constitutional autonomies. Denmark, Finland, France and the Netherlands are federacies , meaning some regions have autonomy but most do not. Spain and Italy have systems of devolution where regions have autonomy, but the national government retains
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#17327795994663224-405: The population they represent, but a sufficient blocking minority can veto the proposal). The Presidency of the Council of the European Union rotates among each of the member states, allowing each state six months to help direct the agenda of the EU. Similarly, each state is assigned seats in Parliament according to their population (smaller countries receiving more seats per inhabitant than
3286-754: The provisions of an untimely transposed Directive is the Verkooijen case, in which the European Court of Justice rendered a judgement on 6 June 2000 (case no. C-35/98). The United Kingdom passed a statutory instrument , the Unfair Terms in Consumer Contracts Regulations 1994 , to implement the EU Unfair Terms in Consumer Contracts Directive 1993 . For reasons that are not clear, the 1994 SI
3348-450: The remaining republics, four operate a semi-presidential system , where competences are shared between the president and prime minister, while one republic operates a presidential system , where the president is head of both state and government. Parliamentary structure in member states varies: there are 15 unicameral national parliaments and 12 bicameral parliaments. The prime minister and government are usually directly accountable to
3410-400: The result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods. A decision shall be binding in its entirety upon those to whom it is addressed. Recommendations and opinions shall have no binding force. The Council can delegate legislative authority to the Commission and, depending on the area and
3472-445: The smaller states in terms of votes and seats in parliament, gives the smaller EU states a greater power of influence than is normally attributed to a state of their size. However most negotiations are still dominated by the larger states. This has traditionally been largely through the " Franco-German motor" but Franco-German influence has diminished slightly following the influx of new members in 2004 (see G6 ). – Article 4 of
3534-405: The state concerned), but sanctions require only a qualified majority. The state in question would still be bound by the obligations treaties and the Council acting by majority may alter or lift such sanctions. The Treaty of Nice included a preventive mechanism whereby the council, acting by majority, may identify a potential breach and make recommendations to the state to rectify it before action
3596-466: The suspension of certain rights. Introduced in the Treaty of Amsterdam , Article 7 outlines that if a member persistently breaches the EU's founding principles (liberty, democracy, human rights and so forth, outlined in TEU Article 2 ) then the European Council can vote to suspend any rights of membership, such as voting and representation. Identifying the breach requires unanimity (excluding
3658-541: The treaties anyway (thus ensuring a right to unilateral withdrawal). There is no formal limit to how much time a member state can take between adopting a policy of withdrawal, and actually triggering Article 50. In a referendum in June 2016 , the United Kingdom voted to withdraw from the EU. The UK government triggered Article 50 on 29 March 2017. After an extended period of negotiation and internal political debate
3720-489: Was Willi Rothley and the vote with the most yes votes was Amendment 9 from the Greens which got 221 against 294 votes out of 532 members voting with 17 abstentions but 314 yes votes would have been required to reach the required an absolute majority to adopt it. On 6 July 1998, a final version was adopted. Its code is 98/44/EC. The Kingdom of the Netherlands brought Case C-377/98 before the European Court of Justice against
3782-437: Was deemed inadequate and was repealed and replaced by the Unfair Terms in Consumer Contracts Regulations 1999 . The Consumer Rights Act 2015 , a major United Kingdom statute consolidating consumer rights, then abolished the 1999 SI; so presumably the 2015 Act complies with the 1993 EU directive, which remains extant. Even though directives were not originally thought to be binding before they were implemented by member states,
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#17327795994663844-516: Was direct support of patient charities and organisations. On the day of the July 1997 vote, a number of people in wheelchairs from these groups demonstrated outside the main hall in Strasbourg , chanting the pharmaceutical industry's slogan, "No Patents, No Cure" in an emotional appeal to Parliamentarians to vote for the Directive. As of 15 January 2007, all of the 27 EU member states had implemented
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