Tag Archives: World Trade Organisation

Accession of the European Community to the Codex Alimentarius Commission

Accession of the European Community to the Codex Alimentarius Commission

Outline of the Community (European Union) legislation about Accession of the European Community to the Codex Alimentarius Commission

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > International dimension and enlargement

Accession of the European Community to the Codex Alimentarius Commission

Document or Iniciative

Council Decision 2003/822/EC of 17 November 2003 on the accession of the European Community to the Codex Alimentarius Commission [Official Journal L 309, 26.11.2003].

Summary

Context

The Codex Alimentarius (or food code) is a joint programme of the FAO (the UN’s Food and Agriculture Organisation) and the WHO (World Health Organisation), which lays down food health standards that serve as a reference for international trade in foodstuffs.

Since 1994 and the entry into force of the WTO Agreements on Sanitary and Phytosanitary Measures (SPS Agreement) and on Technical Barriers to Trade (TBT Agreement), the legal relevance of the Codex standards has increased. Indeed these two Agreements make reference to those standards, meaning that the latter are used as the basis for the evaluation of national measures and regulations.

At present, all Member States of the European Union (EU), and, since the end of 2003, the European Community as such are members of the Codex Alimentarius Commission, which is the body in charge of updating the Codex.

This Decision concerns the application of the European Community to accede to the CAC, achieved in 2003. It is accompanied by a declaration on the exercise of competence between the European Community and its Member States and by the text of the Arrangement between the Council and the Commission regarding preparation for meetings and statements and the exercise of voting rights within the CAC.

Background to the accession negotiations

Since Article 2 of the CAC’s statutes authorises any FAO member to become a full member, the European Community started negotiations to that end in the mid-1990s.
In January 1994, the Council authorised the Commission to enter into negotiations, on behalf of the Community, with the CAC Secretariat with a view to defining the conditions and procedures for the Community’s accession.
Discussions between the Commission and Council had since then been blocked by Member State concerns about internal coordination and the division of responsibilities.
As a result of the White Paper on Food Safety, which reaffirmed the benefits of CAC membership, negotiations with the CAC Secretariat on accession conditions resumed during 2001.

In June 2003, the CAC amended its Rules of Procedure allowing regional economic integration organisations to become members, thus opening the way to the accession of the European Community alongside its Member States.

The Codex Alimentarius Commission: aims and mode of operation

The CAC was created by the WHO and FAO in 1963 to implement their Joint Food Standards Programme aimed at protecting the health of consumers, ensuring fair trade practices in the food trade and promoting coordination of all food standards work undertaken by governmental and international organisations.

Its main aim, then, is to define international standards, codes of practice and other guidelines and recommendations concerning agricultural and fishery products, foodstuffs, food additives, food contaminants, animal feed and the residues of veterinary products and pesticides as well as labelling, inspection and certification systems, analysis and sampling methods, ethics and good farming practice codes and food hygiene practices.
These standards are then published in one of the Codex’s 13 volumes:

  • general requirements and general requirements for food hygiene;
  • general texts on pesticide residues in food and maximum limits for same;
  • residues of veterinary drugs in foods;
  • foods for special dietary uses, including foods for infants and children;
  • processed and quick-frozen fruits and vegetables, fresh fruits and vegetables;
  • fruit juices;
  • cereals, pulses and derived products and vegetable proteins;
  • fats and oils and related products;
  • fish and fishery products;
  • meat and meat products;
  • soups and broths;
  • sugars, cocoa products and chocolate and miscellaneous products;
  • milk and milk products;
  • methods of analysing and sampling.

The CAC’S work also encourages food traders to voluntarily adopt ethical practices. To that end, the CAC has published a Code of ethics for international trade in food, which now forms part of the Codex.

The CAC currently comprises 171 countries and holds meetings every year. It is helped in developing its standards by subsidiary bodies, which include committees dealing with horizontal matters (for example, general principles, labelling, food hygiene, food additives and contaminants, etc.), committees dealing with vertical matters, i.e. specialising in one type of product (for example, milk and milk products, fish and fishery products, etc.), “task forces” dedicated to a particular task of limited duration and regional coordinating committees. In addition, the experts’ meetings organised and supported by the FAO and the WHO provide the essential scientific basis (risk assessment) for the CAC’S work and the publications resulting from their activities act as international references. There are three of these groups of experts, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), the Joint FAO/WHO Meeting on Microbiological Risk Assessment (JEMRA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Activities of the European Community and its Member States within the CAC

The CAC’s Rules of Procedure now allow a member organisation to share its voting rights with its Member States in accordance with their respective competences. When the member organisation is entitled to vote, the number of votes it may cast is equal to the number of Member States present when the vote is taken, hence the importance of Member States being present. This rule is the result of a compromise reached with developing countries, which, in the interests of fairness, could not accept the vote of a country not present being counted.

Competence is assigned as follows:

  • the European Community has exclusive competence for matters on which the rules have already been harmonised, either fully or to a large extent, at Community level. In such cases, the Commission speaks and votes in the name of the Community, although Member States have the right to speak in favour of the Community position and to react to contributions from other countries;
  • the Member States have exclusive competence for all organisational matters (for example, legal or budgetary questions) and for procedural matters (for example, the election of chairpersons, the adoption of agendas and the approval of minutes);
  • competence is shared where rules have been only partially harmonised: the vote is exercised either by the Member States or the Community, depending on the degree of harmonisation achieved. In such cases, the Presidency and the Commission put forward the common position. Member States may also speak in order to support and/or develop the Community position and to react to contributions.

Before each meeting of the CAC or of one of its subsidiary bodies, an annotated agenda, indicating who, within the organisation or its Member States, is competent for each item and is to exercise the right to vote, is drawn up and given to all participants.

In addition, the Member States and the Commission have the right to participate in the Codex working groups and drafting committees and express their opinions there. Member State and Commission representatives endeavour to reach a common position and defend this during discussions in the working groups and drafting committees,

The HACCP principles (Hazard Analysis and Critical Control Point) and the Codex Alimentarius

The measures taken by the EU with regard to food safety and food frequently invoke the Codex as justification. This is true particularly of the HACCP principles, which are the basis of European legislation relating to food hygiene and official controls on products of animal origin intended for human consumption.

These principles, developed by the CAC since the early 1990s, prescribe a number of stages to be followed throughout the production cycle in order to allow, on the basis of a risk analysis, the identification of critical points that need to be monitored to ensure food safety:

  • identification of all risks to be avoided, eliminated or reduced to acceptable levels;
  • identification of the critical or limit points where surveillance becomes essential;
  • establishment and application of effective procedures for monitoring critical points;
  • adoption of corrective measures when monitoring reveals a critical point is being overstepped.

Relationship between the WTO and the Codex Alimentarius

When the WTO was set up in April 1994, two specific agreements were concluded in Marrakech to restrict barriers to trade justified on the basis of protectionist technical regulations:

  • the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement);
  • the Agreement on Technical Barriers to Trade (TBT Agreement).

The SPS Agreement lays down the conditions on which a State can adopt and implement health measures (animal health, food safety) or phytosanitary measures (protection of plants) that have a direct or indirect impact on international trade. This Agreement makes explicit reference to the standards defined by the Codex to impose limits on the actions of the signatory States.
Thus the preamble to this Agreement declares itself in favour of furthering “the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organisations, including the Codex Alimentarius Commission”.

The TBT Agreement aims to guarantee that technical regulations and standards do not create unnecessary obstacles to international trade. It too makes extensive reference to international standards, though without explicitly citing the Codex, in the context of the harmonisation that it advocates.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Decision 2003/822/EC 17.11.2003 OJ L 309 of 26.11.2003

Agreement on intellectual property rights relating to trade and pharmaceutical patents

Agreement on intellectual property rights relating to trade and pharmaceutical patents

Outline of the Community (European Union) legislation about Agreement on intellectual property rights relating to trade and pharmaceutical patents

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Agreement on intellectual property rights relating to trade and pharmaceutical patents

Document or Iniciative

Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994).

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Summary

GENERAL PROVISIONS AND BASIC PRINCIPLES

The principles are those of national treatment and most-favoured-nation treatment. Thus, members of the World Trade Organisation (WTO) must accord the nationals of other members’ treatment no less favourable than that they accord to their own nationals. Moreover, any advantage granted by a member to nationals of another member must be accorded immediately and unconditionally to the nationals of all other members even if this treatment is more favourable than that accorded to its own nationals.

The Agreement aims to ensure that adequate rules on the protection of intellectual property are applied in all member countries, on the basis of the basic obligations laid down by the WIPO (World Intellectual Property Organisation) in the various conventions on intellectual property rights, particularly the Paris Convention for the Protection of Industrial Property. Numerous new rules or stricter rules are introduced in fields not covered by the existing conventions or where the existing conventions are inadequate.

The agreement covers a vast range of topics, from copyright and trademarks to layout-designs of integrated circuits and trade secrets. Patents protecting pharmaceutical products and other products are just one part of this agreement.

INTELLECTUAL PROPERTY RIGHTS FOR PHARMACEUTICAL PATENTS

Patents provide the patent owner with the legal means to prevent others from making, using, or selling the new invention for a limited period of time, subject to a number of exceptions. Patents do not constitute marketing authorisations.

The TRIPS Agreement stipulates that it must be possible for all inventions to be protected by a patent for 20 years, whether for a product (such as a medicine) or a process (a method of producing an ingredient for a medicine). To qualify for a patent, an invention has to be “new”, it must be an “inventive step” and it must have “industrial applicability”. In addition, patented inventions have to be disclosed; enabling others to study the invention even while it is patent protected.

Governments can refuse to grant patents for the three reasons set out below:

  • for inventions whose commercial exploitation needs to be prevented to protect human, animal or plant life or health;
  • for diagnostic, therapeutic and surgical methods for treating humans or animals;
  • for certain plant and animal inventions.

Governments also play a supervisory role and can act to prevent patent owners from abusing these rights (anti-competitive practices) or hampering the transfer of technology.

The TRIPS Agreement makes provision for limited exceptions to patent rights. These exceptions must not “unreasonably” conflict with the “normal” exploitation of the patent. These exceptions are used in very different instances and in particular:

  • to advance science and facilitate the transfer of technology, by allowing researchers to use a patented invention for research (research exception);
  • to speed up the process of marketing a generic drug. Some countries allow manufacturers of generic drugs to use the patented invention to obtain marketing approval without the patent owner’s permission and before the patent protection expires. The generic producers can then market their versions as soon as the patent expires, since the (generally very lengthy) procedure involved in obtaining marketing authorisation has already been completed. This provision is called the “Bolar provision”.

Flexibility in the application of patent law: compulsory licensing and parallel imports

In addition to the two exceptions to patent law mentioned above (Bolar provision and research exceptions), the TRIPS agreement make provision for two other forms of flexibility: compulsory licensing and parallel imports. These two systems should make it possible to strike a balance between promoting access to existing drugs and promoting research and development into new drugs.

Compulsory licensing

Governments can issue compulsory licences when they allow someone else to produce the patented product or use the patented process without the consent of the patent owner. The granting of compulsory licences without the authorisation of the patent owner can only be done under certain conditions aimed at protecting the legitimate interests of the patent holder. In particular, the party applying for a licence must have first attempted, unsuccessfully, to obtain a voluntary licence from the right holder on reasonable commercial terms and within a reasonable period of time. In addition, these compulsory licences should be granted mainly to supply the domestic market.

There is, however, no need to apply for a voluntary licence in advance in the following cases:

  • national emergencies;
  • other circumstances of extreme urgency;
  • public non-commercial use;
  • anti-competitive practices.

Parallel imports

The term parallel imports is used when products manufactured and marketed by the patent holder in one country are imported by another company. The legal principle here is “exhaustion”, the idea that once a pharmaceutical company has sold its product its patent rights are exhausted and it no longer has any rights over what happens to the product. This therefore allows any other company to buy the product in a country where the selling price is lower and import it in order to profit financially from the difference in prices. The TRIPS agreement points out that disputes relating to these parallel imports cannot be handled by the WTO. This means in effect, as stated in the Doha Declaration, that each member of the WTO remains free to establish its own regime for exhaustion.

IMPLMENTATION OF THE AGREEMENT

Enforcement of intellectual property rights

The laws of the member countries of the WTO must include procedures to ensure that intellectual property rights are respected both by foreign right holders and by their own nationals. These procedures must permit effective action against any act of infringement of these rights. They must be fair and equitable, they must not be unnecessarily complicated or costly, and they must not entail unreasonable time limits. Final administrative decisions may be reviewed by a judicial authority.

The Agreement provides details concerning evidence, injunctions, damages, provisional measures and other remedies.

Transition period

With regard to the application of the Agreement, developed countries have a period of one year to bring their legislation and practices into line with the Agreement. This period is extended to five years (i.e. to 2000) for developing countries and countries in the process of transformation from a centrally-planned economy to a market economy, and to eleven years (i.e. to 2006) for the least-developed countries (LDC), with the possibility for the latter to obtain an extension. On 29 November 2005, the Council for TRIPS decided to extend the transitional period for LDCs until 1 July 2013.

In the case of pharmaceutical products, developing countries that did not provide product patent protection on 1 January 1995 (when the TRIPS Agreement came into force) have up to 10 years to introduce this protection. In the meantime they have to comply with two obligations:

  • they must allow inventors to file patent applications from 1 January 1995, even though the decision on whether or not to grant any patent itself need not be taken until the end of this transition period (the “mailbox” provision);
  • if the government allows a pharmaceutical product to be marketed during the transition period, the country in question must grant the patent applicant an exclusive marketing right for the product for five years.

Institutional framework

The Agreement created a Council for Trade-Related Aspects of Intellectual Property Rights (the Council for TRIPS). It is responsible for monitoring the operation of the Agreement, ensuring that members comply with their obligations and affording opportunities for consultations between members.

The settlement of disputes over intellectual property is governed by the dispute settlement procedures adopted following the Uruguay Round negotiations.

Act Entry into force Deadline for transposition in the Member States Official Journal
Decision 94/800/EC Effective date: 22.10.1994
Date of entry into force: 01.01.1995
Official Journal L 336 of 23.12.1994

Related Acts

of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems

The purpose of this Regulation is to harmonise within the European Union (EU) the conditions for granting compulsory export licences to companies intending to manufacture generic medicinal products for export to developing countries which do not have sufficient production capacity of their own. The Regulation aims to prevent distortion of competition among operators in the single market and to apply uniform rules in order to avoid the reimport into the EU of pharmaceutical products manufactured under the compulsory licences.

Ministerial Declaration on the TRIPS agreement and public health adopted on 14 November 2001 (Doha Declaration)
This Declaration on the TRIPS agreement and public health seeks to address the concerns expressed by developing countries regarding the possible implications of the TRIPS agreement on access to medicines.
The Declaration interprets some of the key provisions of the TRIPS agreement. The Ministers reaffirm the right of the member countries to use the flexibilities that are built into the TRIPS Agreement, in particular compulsory licensing and parallel importing.
The WTO members also agreed to extend exemptions on pharmaceutical patent protection for least-developed countries at least until 2016.
Finally, the ministers assigned the TRIPS Council the additional task of sorting out how to provide extra flexibility, so that countries unable to produce pharmaceuticals domestically can import patented drugs made under compulsory licensing.

Decision adopted by the WTO General Council on 30 August 2003

The decision adopted by the WTO General Council on 30 August 2003 allows countries that can make drugs to export drugs made under compulsory licence to countries that cannot manufacture them. This authorisation constitutes a derogation from the TRIPS agreement since products made under compulsory license must normally be predominantly for the domestic market. This will therefore make it easier for poorer countries to import cheaper generics made under compulsory licensing if they are unable to manufacture these themselves. For a long time, the stumbling block for negotiations within the WTO was determining which diseases were covered by the decision. In the end, the decision refers to the Doha Declaration that covers “the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.” It is now widely accepted that this coverage is fairly flexible.
The August 2003 decision also introduces safeguards in order to prevent rich countries profiting from the system by diverting trade through smuggling. A statement accompanies the decision from the Chairperson of the WTO General Council that is intended to reassure countries who feared that the decision might be abused. It points out that the system of derogations introduced will be used “in good faith to protect public health and not as an instrument to pursue industrial or commercial policy objectives”.
Finally, the decision of August 2003 lays down that the decisions taken in it should be put into practice by an amendment to the TRIPS agreement by mid-2004. On 6 December 2005, the WTO General Council adopted the decision, changing the provisional agreement of August 2003 into an amendment to the TRIPS agreement. WTO members have until 1 December 2007 to accept the amendment.

 


Another Normative about Agreement on intellectual property rights relating to trade and pharmaceutical patents

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Internal market > Businesses in the internal market > Intellectual property

Agreement on intellectual property rights relating to trade and pharmaceutical patents

Document or Iniciative

Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994).

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Summary

GENERAL PROVISIONS AND BASIC PRINCIPLES

The principles are those of national treatment and most-favoured-nation treatment. Thus, members of the World Trade Organisation (WTO) must accord the nationals of other members’ treatment no less favourable than that they accord to their own nationals. Moreover, any advantage granted by a member to nationals of another member must be accorded immediately and unconditionally to the nationals of all other members even if this treatment is more favourable than that accorded to its own nationals.

The Agreement aims to ensure that adequate rules on the protection of intellectual property are applied in all member countries, on the basis of the basic obligations laid down by the WIPO (World Intellectual Property Organisation) in the various conventions on intellectual property rights, particularly the Paris Convention for the Protection of Industrial Property. Numerous new rules or stricter rules are introduced in fields not covered by the existing conventions or where the existing conventions are inadequate.

The agreement covers a vast range of topics, from copyright and trademarks to layout-designs of integrated circuits and trade secrets. Patents protecting pharmaceutical products and other products are just one part of this agreement.

INTELLECTUAL PROPERTY RIGHTS FOR PHARMACEUTICAL PATENTS

Patents provide the patent owner with the legal means to prevent others from making, using, or selling the new invention for a limited period of time, subject to a number of exceptions. Patents do not constitute marketing authorisations.

The TRIPS Agreement stipulates that it must be possible for all inventions to be protected by a patent for 20 years, whether for a product (such as a medicine) or a process (a method of producing an ingredient for a medicine). To qualify for a patent, an invention has to be “new”, it must be an “inventive step” and it must have “industrial applicability”. In addition, patented inventions have to be disclosed; enabling others to study the invention even while it is patent protected.

Governments can refuse to grant patents for the three reasons set out below:

  • for inventions whose commercial exploitation needs to be prevented to protect human, animal or plant life or health;
  • for diagnostic, therapeutic and surgical methods for treating humans or animals;
  • for certain plant and animal inventions.

Governments also play a supervisory role and can act to prevent patent owners from abusing these rights (anti-competitive practices) or hampering the transfer of technology.

The TRIPS Agreement makes provision for limited exceptions to patent rights. These exceptions must not “unreasonably” conflict with the “normal” exploitation of the patent. These exceptions are used in very different instances and in particular:

  • to advance science and facilitate the transfer of technology, by allowing researchers to use a patented invention for research (research exception);
  • to speed up the process of marketing a generic drug. Some countries allow manufacturers of generic drugs to use the patented invention to obtain marketing approval without the patent owner’s permission and before the patent protection expires. The generic producers can then market their versions as soon as the patent expires, since the (generally very lengthy) procedure involved in obtaining marketing authorisation has already been completed. This provision is called the “Bolar provision”.

Flexibility in the application of patent law: compulsory licensing and parallel imports

In addition to the two exceptions to patent law mentioned above (Bolar provision and research exceptions), the TRIPS agreement make provision for two other forms of flexibility: compulsory licensing and parallel imports. These two systems should make it possible to strike a balance between promoting access to existing drugs and promoting research and development into new drugs.

Compulsory licensing

Governments can issue compulsory licences when they allow someone else to produce the patented product or use the patented process without the consent of the patent owner. The granting of compulsory licences without the authorisation of the patent owner can only be done under certain conditions aimed at protecting the legitimate interests of the patent holder. In particular, the party applying for a licence must have first attempted, unsuccessfully, to obtain a voluntary licence from the right holder on reasonable commercial terms and within a reasonable period of time. In addition, these compulsory licences should be granted mainly to supply the domestic market.

There is, however, no need to apply for a voluntary licence in advance in the following cases:

  • national emergencies;
  • other circumstances of extreme urgency;
  • public non-commercial use;
  • anti-competitive practices.

Parallel imports

The term parallel imports is used when products manufactured and marketed by the patent holder in one country are imported by another company. The legal principle here is “exhaustion”, the idea that once a pharmaceutical company has sold its product its patent rights are exhausted and it no longer has any rights over what happens to the product. This therefore allows any other company to buy the product in a country where the selling price is lower and import it in order to profit financially from the difference in prices. The TRIPS agreement points out that disputes relating to these parallel imports cannot be handled by the WTO. This means in effect, as stated in the Doha Declaration, that each member of the WTO remains free to establish its own regime for exhaustion.

IMPLMENTATION OF THE AGREEMENT

Enforcement of intellectual property rights

The laws of the member countries of the WTO must include procedures to ensure that intellectual property rights are respected both by foreign right holders and by their own nationals. These procedures must permit effective action against any act of infringement of these rights. They must be fair and equitable, they must not be unnecessarily complicated or costly, and they must not entail unreasonable time limits. Final administrative decisions may be reviewed by a judicial authority.

The Agreement provides details concerning evidence, injunctions, damages, provisional measures and other remedies.

Transition period

With regard to the application of the Agreement, developed countries have a period of one year to bring their legislation and practices into line with the Agreement. This period is extended to five years (i.e. to 2000) for developing countries and countries in the process of transformation from a centrally-planned economy to a market economy, and to eleven years (i.e. to 2006) for the least-developed countries (LDC), with the possibility for the latter to obtain an extension. On 29 November 2005, the Council for TRIPS decided to extend the transitional period for LDCs until 1 July 2013.

In the case of pharmaceutical products, developing countries that did not provide product patent protection on 1 January 1995 (when the TRIPS Agreement came into force) have up to 10 years to introduce this protection. In the meantime they have to comply with two obligations:

  • they must allow inventors to file patent applications from 1 January 1995, even though the decision on whether or not to grant any patent itself need not be taken until the end of this transition period (the “mailbox” provision);
  • if the government allows a pharmaceutical product to be marketed during the transition period, the country in question must grant the patent applicant an exclusive marketing right for the product for five years.

Institutional framework

The Agreement created a Council for Trade-Related Aspects of Intellectual Property Rights (the Council for TRIPS). It is responsible for monitoring the operation of the Agreement, ensuring that members comply with their obligations and affording opportunities for consultations between members.

The settlement of disputes over intellectual property is governed by the dispute settlement procedures adopted following the Uruguay Round negotiations.

Act Entry into force Deadline for transposition in the Member States Official Journal
Decision 94/800/EC Effective date: 22.10.1994
Date of entry into force: 01.01.1995
Official Journal L 336 of 23.12.1994

Related Acts


Regulation (EC) No 816/2006

of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems

The purpose of this Regulation is to harmonise within the European Union (EU) the conditions for granting compulsory export licences to companies intending to manufacture generic medicinal products for export to developing countries which do not have sufficient production capacity of their own. The Regulation aims to prevent distortion of competition among operators in the single market and to apply uniform rules in order to avoid the reimport into the EU of pharmaceutical products manufactured under the compulsory licences.

Ministerial Declaration on the TRIPS agreement and public health adopted on 14 November 2001 (Doha Declaration)
This Declaration on the TRIPS agreement and public health seeks to address the concerns expressed by developing countries regarding the possible implications of the TRIPS agreement on access to medicines.
The Declaration interprets some of the key provisions of the TRIPS agreement. The Ministers reaffirm the right of the member countries to use the flexibilities that are built into the TRIPS Agreement, in particular compulsory licensing and parallel importing.
The WTO members also agreed to extend exemptions on pharmaceutical patent protection for least-developed countries at least until 2016.
Finally, the ministers assigned the TRIPS Council the additional task of sorting out how to provide extra flexibility, so that countries unable to produce pharmaceuticals domestically can import patented drugs made under compulsory licensing.

Decision adopted by the WTO General Council on 30 August 2003

The decision adopted by the WTO General Council on 30 August 2003 allows countries that can make drugs to export drugs made under compulsory licence to countries that cannot manufacture them. This authorisation constitutes a derogation from the TRIPS agreement since products made under compulsory license must normally be predominantly for the domestic market. This will therefore make it easier for poorer countries to import cheaper generics made under compulsory licensing if they are unable to manufacture these themselves. For a long time, the stumbling block for negotiations within the WTO was determining which diseases were covered by the decision. In the end, the decision refers to the Doha Declaration that covers “the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.” It is now widely accepted that this coverage is fairly flexible.
The August 2003 decision also introduces safeguards in order to prevent rich countries profiting from the system by diverting trade through smuggling. A statement accompanies the decision from the Chairperson of the WTO General Council that is intended to reassure countries who feared that the decision might be abused. It points out that the system of derogations introduced will be used “in good faith to protect public health and not as an instrument to pursue industrial or commercial policy objectives”.
Finally, the decision of August 2003 lays down that the decisions taken in it should be put into practice by an amendment to the TRIPS agreement by mid-2004. On 6 December 2005, the WTO General Council adopted the decision, changing the provisional agreement of August 2003 into an amendment to the TRIPS agreement. WTO members have until 1 December 2007 to accept the amendment.

 

LeaderSHIP 2015

LeaderSHIP 2015

Outline of the Community (European Union) legislation about LeaderSHIP 2015

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Transport > Waterborne transport

LeaderSHIP 2015

Document or Iniciative

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions of 21 November 2003: LeaderSHIP 2015 – Defining the future of the European Shipbuilding and Repair Industry – Competitiveness through Excellence [COM(2003) 717 final – Not published in the Official Journal].

Summary

In January 2003, the Commission set up the LeaderSHIP 2015 Advisory Group. This group was made responsible for drafting recommendations to improve the competitiveness of the shipbuilding and repair sector. In this notice, the Commission presents the recommendations, divided into eight fields of crucial importance for the competitiveness of the sector.

A level playing field for shipbuilding worldwide

European shipbuilding essentially suffers from unfair competition from certain countries. This takes the form of prices set below cost levels and injurious subsidisation. The Commission therefore approves the following three recommendations made by the LeaderSHIP 2015 Group:

  • continuation of the EU’s current commercial policy;
  • implementation of the rules of the World Trade Organisation (WTO) applicable to shipbuilding;
  • negotiation within the Organisation for Economic Cooperation and Development (OECD) of an agreement on shipbuilding and the application of the existing rules.

Research, development and innovation

In order for the shipbuilding sector to receive sufficient support from the Member States for its research activities, the Commission has adapted the rules governing innovation aid for the shipbuilding sector.

Financing

The shipbuilding sector needs substantial financing for both the construction phase (pre-delivery) and the operational phase (post-delivery) of the vessel. However, many banks are losing interest in shipbuilding. The Commission therefore proposes that the European Investment Bank support pre- and post-delivery financing.

In view of the risks linked to markets in foreign currencies, the Commission suggests organising an exchange-rate risk insurance system at European level.

Safety and environment

In the fields of maritime safety and protection of the marine environment, the Commission supports all the recommendations made by the LeaderSHIP 2015 Group:

  • the strict application of European legislation and its promotion on an international scale;
  • more transparent, uniform, efficient and independent inspections;
  • the establishment of a programme to assess the quality of shipyards throughout the world, also covering the construction of new ships and repairs;
  • improvements in ship repairs;
  • the creation of an expert committee to assist the Commission and the European Maritime Safety Agency;
  • exploitation of the potential of short-distance maritime transport.

European approach to shipbuilding needs

The naval defence industry does not have the same needs as the commercial naval sector. The Commission is in favour of creating a common market for defence equipment. It also approves the following proposals:

  • the strengthening of cooperation between shipyards, particularly between different Member States. The creation of highly integrated European stakeholders will encourage European competitiveness;
  • the harmonisation of export rules by the Member States. Such harmonisation would make it possible to avoid distortions of competition and increase industrial cooperation.

Intellectual property rights (IPRs)

In order to protect the shipbuilding industry from pirating and the violation of intellectual property rights, the Commission supports the following initiatives:

  • maximum use of existing IPR instruments (copyrights, registered designs and models, trademarks, patents, specific non-disclosure and cooperation agreements);
  • the creation of databases containing information on the state of the art, existing patents, the competitive situation for certain products and the main right holders;
  • the examination, and even reinforcement, of international patent rules.

Education and training

In order to keep a skilled workforce and attract young people, the following measures are recommended:

  • the development of management training programmes specific to the shipbuilding sector. New management skills will be needed in order to adapt to the new structure of the industry, which comprises a few large businesses and many subcontractors;
  • increased sectoral social dialogue should make it possible to meet new qualification needs. The Commission has in fact established a social dialogue committee for the sector;
  • the exchange of staff and know-how, university workshops;
  • the launch of an advertising campaign to improve the image of the sector;
  • the creation of regional centres of excellence to support the implementation of these recommendations. Businesses and educational establishments could participate in these centres of excellence, thus facilitating student exchanges, transfers of knowledge, the dissemination of good practices and the recognition of qualifications throughout the EU.

Building a stable industrial structure

The sector has specific needs which require an appropriate response. The Member States must acknowledge the important strategic dimension of shipbuilding and ship repair in Europe. They need to develop a political approach to the sector in order to prevent its extinction in the near future. Furthermore, for security reasons, it is important to preserve some shipbuilding capacity for both maritime transport and defence.

Lastly, greater cooperation between naval defence and shipbuilding resources in Europe can also help to improve the competitiveness of the sector.

Related Acts

Commission working document of 25 April 2007 – LeaderSHIP 2015 Progress Report [COM(2007) 220 – Not published in the Official Journal].
The LeaderSHIP 2015 strategy is achieving results. The sector is no longer perceived as a subsidised industry on the decline, but is now seen as a modern, efficient industry which creates growth and jobs. The Commission intends to continue with the initiative, accelerating it in a number of fields.

World Trade Organisation

World Trade Organisation

Outline of the Community (European Union) legislation about World Trade Organisation

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Financial services: general framework

World Trade Organisation

Document or Iniciative

Council Decision 1999/61/EC of 14 December 1998 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the results of the World Trade Organisation negotiations on financial services. (pdf )

Summary

When the Uruguay Round of trade negotiations was concluded in December 1993, it was not possible to include the financial services sector on a permanent basis in GATS. The Uruguay Round commitments on financial services therefore came into force for a limited period, which expired on 30 June 1995. A successive interim agreement was concluded by certain WTO members (excluding the United States) in order to maintain the commitments they had entered into until December 1997.

On 12 December 1997 the Committee on Trade in Financial Services approved the results of the negotiations on financial services, whereby those services are to be included in GATS on a permanent basis and in accordance with the most-favoured nation (MFN) principle.

The aim of the Council Decision is to approve on behalf of the European Community the Fifth Protocol to the General Agreement on Trade in Services, under which the financial services sections of the schedules of specific commitments and the lists of MFN exemptions of the members concerned are to be replaced by the lists annexed to the Protocol.

The schedule of specific commitments of the European Communities (GATS/SC/31/Suppl.4) sets out the limitations on market access, listed by sector (insurance, banking and other financial services), applicable in each Member State. Likewise, the list of MFN exemptions (GATS/EL/31) sets out, in accordance with the same criteria, the limitations on national treatment.

A list of additional commitments is also annexed to the Protocol. It contains specific provisions which are binding on the European Communities and their Member States, particularly in the insurance sector.

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Decision 1999/61/EC 14.12.1998 OJ L 20 of 27.1.2999

Protection against trade barriers

Protection against trade barriers

Outline of the Community (European Union) legislation about Protection against trade barriers

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

External trade

Protection against trade barriers

Document or Iniciative

Council Regulation (EC) No 3286/94 of 22 December 1994 laying down Community procedures in the field of the common commercial policy in order to ensure the exercise of the Community’s rights under international trade rules, in particular those established under the auspices of the World Trade Organisation [See amending acts].

Summary

This regulation replaces the 1984 regulation on illicit practices. It covers trade barriers that may impede European Union (EU) exports to third country markets.

The scope of the trade barriers regulation is broader than that relating to illicit practices. The regulation applies not only to goods but also to certain services, particularly cross-border services.

Definitions

The term “obstacle to trade” (i.e. trade barrier) refers to any trade practice adopted by a third country but prohibited by international trade rules which give a party affected by the practice a right to seek elimination of the effect of the practice in question. These international trade rules are essentially those of the WTO and those set out in bilateral agreements with third countries to which the EU is a party.

The regulation defines “injury” as any material injury which an obstacle to trade threatens to cause to an EU industry on the market of the EU.

“Adverse trade effects” are those which an obstacle to trade threatens to cause to EU enterprises on the market of any third country, and which have a material impact on the economy of the EU or of a region of the EU, or on a sector of economic activity therein.

The term “EU industry” means all EU producers or providers of products or services which are the subject of an obstacle to trade or all those producers or providers whose combined output constitutes a major proportion of total EU production of the products or services in question.

The term “EU enterprise” means a company formed in accordance with the law of an EU country and having its registered office, central administration or principal place of business within the EU, directly concerned by the production of goods or the provision of services which are the subject of the obstacle to trade.

Right of referral

Complaints under this regulation may be lodged in three ways:

  • on behalf of an EU industry that has suffered material injury as a result of trade barriers that have an effect on the market of the EU;
  • on behalf of one or more EU enterprises that have suffered adverse trade effects as a result of trade barriers that have an effect on the market of a third country;
  • by an EU country denouncing an obstacle to trade.

The complaint must contain sufficient evidence of the existence of the trade barriersand of the injury or adverse trade effects resulting therefrom. In examining injury or adverse trade effects, the Commission will take account of certain factors such as the volume of EU imports or exports concerned, the prices of the EU industry’s competitors, the rate of increase of exports to the market where the competition with EU products is taking place, the export capacity in the country of origin or export, and so on.

Examination procedures

Complaints must be submitted to the Commission in writing. The Commission will decide on the admissibility of a complaint within 45 days. This period may be suspended at the request of the complainant in order to allow the provision of complementary information.

The regulation has provided for a consultation procedure by establishing an advisory committee composed of representatives of each EU country and chaired by a representative of the Commission. This committee is used as the forum for providing the EU countries with information and is where they can express their opinions either in writing or by requesting an oral consultation.

If a complaint is deemed admissible, an examination is initiated and announced through publication of an announcement in the Official Journal of the European Communities. This announcement will indicate the product or service and countries concerned. The Commission will then gather all the relevant information from the parties involved.

When it is found as a result of the examination procedure that the interests of the EU do not require any action to be taken, the procedure will be terminated. When, after an examination procedure, the third country or countries concerned take measures to eliminate the adverse trade effects or injury referred to by the complainant, the procedure may be suspended. It may also be suspended in order to try to find an amicable solution that may result in the conclusion of an agreement between the third country or countries concerned and the EU.

Adoption of commercial policy measures

Where it is found, as a result of the examination procedure, that action is necessary in the interests of the EU in order to ensure the exercise of the EU’s rights, the appropriate measures will be determined on the basis of the regulation. These measures may include:

  • suspension or withdrawal of any concession resulting from commercial policy negotiations;
  • the raising of existing customs duties or the introduction of any other charge on imports;
  • the introduction of quantitative restrictions or any other measures modifying import or export conditions or otherwise affecting trade with the third country concerned.

Where the EU’s international obligations require it to follow prior international consultation or dispute settlement procedures, these measures may only be implemented at the end of these procedures and in accordance with their conclusions.

The Council must rule on the Commission proposal within 30 days of receiving the proposal.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 3286/94

1.1.1995

OJ L 349 of 31.12.1994

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 356/95

24.2.1995

OJ L 41 of 23.2.1995

Regulation (EC) No 125/2008

5.3.2008

OJ L 40 of 14.2.2008

Successive amendments and corrections to Regulation (EC) No 3286/94 have been incorporated into the basic text. This consolidated version is for reference only.

Related Acts

Communication from the Commission – Global Europe – Europe’s trade defence instruments in a changing global economy – A Green Paper for public consultation [COM(2006) 763 final].
This Green Paper forms part of the process launched in October 2006 to reflect upon and give a fresh impetus to competitiveness in the EU as part of the global economy. In this context, the Commission has launched a procedure to reflect on how trade defence instruments (anti-dumping, anti-subsidy and safeguard measures) can continue to be used to best effect in the EU interest. The latter are in fact based on World Trade Organisation (WTO) rules and help protect the EU from unfair trade as well as manage the consequences of globalisation. Another factor is that the context in which trade defence instruments are adopted has changed.

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions – Global Europe – Competing in the world – A contribution to the EU’s Growth and Jobs Strategy [COM(2006) 567 final – Not published in the Official Journal].

A stronger partnership to deliver market access

A stronger partnership to deliver market access

Outline of the Community (European Union) legislation about A stronger partnership to deliver market access

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Enterprise > International dimension and enlargement

A stronger partnership to deliver market access

The Commission proposes a stronger partnership with European companies and Member States to deliver market access. It is setting priorities and calling for efficient and transparent market access tools.

Document or Iniciative

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions of 18 April 2007: “Global Europe: a stronger partnership to deliver market access for European exporters” [COM(2007) 183 final – Not published in the Official Journal].

Summary

In today’s global economy, market access significantly influences the economic strength of European companies and exporters. Establishing an efficient commercial policy is indispensable for growth and employment and ensures that European companies remain competitive and have genuine market access.

In the interest of fair competition, emerging economies must further open their markets and bring down their barriers to trade. The European Union (EU) is prepared to do the same in order to promote competition and innovation and attract foreign investment.

Given that progressive market liberalisation leads to positive results for both developed and developing countries, the EU is prioritising its commitments to the World Trade Organisation (WTO) and the Doha Development Agenda. However, a renewed policy, focused on specific problems and markets, is needed.

The Commission proposes a stronger partnership with Member States and European businesses with a view to establishing a clearer, more results-oriented approach. This partnership must focus on:

  • specific problems encountered in third-country markets;
  • identifying weaknesses in the current system;
  • how EU policy must change to reflect a changing global economy.

The Commission plans to decentralise the current system, rendering it more efficient and transparent, and make better use of local knowledge and initiative through the development of specialist EU teams made up of representatives from the Commission, Member States and companies. Finally, it calls for Community priorities to be defined in order to focus on the most pressing challenges.

Market access in a changing global economy

The trade barriers in today’s global economy are:

  • tariff barriers and burdensome customs procedures;
  • restrictions on access to raw materials;
  • barriers to trade in services and to foreign direct investment;
  • restrictive government procurement practices;
  • unfair or discriminatory fiscal practices (reliance on State aid, subsidies and methods in breach of WTO trade defence rules such as the anti-dumping measures);
  • misuse of unjustified measures concerning health, safety and technical regulations;
  • poor protection and inadequate implementation of intellectual property rights (IPR).

These barriers to trade are complicated and difficult to detect. Non-tariff and other “behind-the-border” barriers are increasingly important. Many market access problems now arise because existing rules are not correctly implemented. Only better coordination between Member States, businesses and the Commission can make it easier to detect, analyse, assess and eliminate them.

Stakeholders’ support for change

Consultation of the stakeholders confirmed that market access requires stronger action at Community level and a more results-oriented approach. The recommendations include:

  • improving the mix of policy instruments;
  • engaging actively in multilateral and bilateral negotiations;
  • taking steps to ensure that agreements are enforced;
  • maximising results though closer cooperation between the Commission, Member States and businesses;
  • better prioritising of action against barriers to trade;
  • offering businesses a more efficient and transparent service;
  • eliminating barriers to trade in goods and services, intellectual property and investment.

The right mix of policy instruments to deliver market access

We cannot rely on a single avenue or mechanism to tackle trade barriers. Although the WTO system and multilateral cooperation are still the best way to guarantee market access, we must use formal and informal multilateral and bilateral instruments. In the WTO, successful completion of the Doha round is the EU’s priority. The scope for using accession negotiations to secure greater market access is constantly diminishing, as the most important trading countries have now joined the WTO (China) or are about to do so (Russia). Multilateral cooperation will thus be strengthened by the launch of new negotiations on bilateral Free Trade Agreements with ASEAN, Korea, India, the Andean and Central American countries, as well as by the continuation of talks with Mercosur and the Gulf Cooperation Council.

Rights under the WTO Dispute Settlement Understanding should be actively pursued, taking advantage of flexible dispute avoidance and resolution mechanisms based on mediation. To this end, complaints against violation of bilateral treaties will be included in the Trade Barriers Regulation.

The EU’s position in international standardisation bodies will be reinforced, giving it greater influence in international cooperation.

However, compliance with the rules is largely dependent on administrative capacities, training instruments and technical infrastructures. The Commission and the EU are therefore committed to increasing trade-related assistance in order to reduce these constraints. The Commission also proposes to encourage third countries to use notification procedures to lift trade restrictions.

Finally, it reaffirms the increasingly important role played by political contacts and international diplomacy, in addition to other policy instruments, in tackling barriers to trade.

Towards a stronger partnership

The Commission proposes the establishment of a new partnership with Member States and European businesses. These trilateral discussions will lead to the identification of better ways of working with a view to:

  • establishing priorities for action in removal of trade barriers;
  • linking up databases;
  • developing a network of market access specialists.

Commission delegations, Member States’ embassies and European businesses operating abroad are best placed to:

  • identify the problems encountered;
  • determine whether coordinated action with different specialists is required;
  • conduct local follow-up.

The efficency of this joint effort depends on contacts and systematic cooperation, making it possible to improve information collection, identify legislative proposals and use local knowledge.

In Brussels, the “Market Access” Advisory Committee is tasked with:

  • promoting the exchange of best practice;
  • enhancing coordination;
  • working closely with the Trade Barriers Regulation Committee.

Although the overall advisory committee on trade policy (133 Committee) remains the main forum for discussion, other specialist committees will continue to play an important role. The Commission will discuss market access issues on a regular basis with the European Parliament.

Establishing priorities

Given the increasing complexity of trade barriers, making them more difficult to detect and remove, we need to focus on the highest priorities, namely:

  • economic benefits in the short and the medium term for EU businesses;
  • barriers representing a serious infringement of an agreement;
  • resolution of the problem within a reasonable timeframe.

Priorities will be defined in terms of countries, sectors and categories of problem.

However, prioritisation must not be a straitjacket; rather it must provide guidance for using resources better.

A more effective and transparent service

A prevention-based “early warning” approach allows potential barriers to be identified and tackled at source and means that any concerns are made known before draft regulations or legislation are set in stone. The main challenge is the time needed to successfully remove barriers. European businesses need quicker, more responsive action. The Commission therefore proposes to improve and streamline the way it registers, analyses and tackles complaints.

It is the role of European businesses to provide much of the information on barriers to market access. The Commission’s role is to ensure that this information is shared by registering the complaints received in the Market Access Database and establishing web-links with other databases for greater accessibility. This database, which is available on line, provides rapidly accessible and reliable information with regard to applied tariffs, trade barriers, import formalities and documentary requirements for imports. The Commission is launching a promotional campaign in and with the Member States to raise the profile of the database and encourage European companies to register their complaints. Cases will be given a unique registration number to facilitate their tracking through the system in a transparent manner. Moreover, the Commission undertakes to update the information available on the database and develop new sections over time to improve its coverage in areas such as services, IPR enforcement and investment. The Commission is currently looking at ways to link the Market Access Database and the Helpdesk for Developing Country Exporters.

Conclusions

A stronger partnership to deliver market access is needed to achieve a global Europe and represents a significant contribution to the Lisbon agenda for growth and jobs. The success of the current initiative will depend on:

  • the strength of the new partnership;
  • the allocation of sufficient resources;
  • optimum use of resources.

The Commission is committed to taking up this challenge and calls for the participation of all interested parties.

Further information on the DG External Trade website.

Related Acts

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions of 4 October 2006:”Global Europe: Competing in the World”[COM (2006) 567 final – Not published in the Official Journal].