Tag Archives: Developing countries

Taking EU-Africa dialogue forward

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Taking EU-Africa dialogue forward

Outline of the Community (European Union) legislation about Taking EU-Africa dialogue forward

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

Development > African Caribbean and Pacific states (ACP)

Taking EU-Africa dialogue forward

Document or Iniciative

Communication from the Commission to the Council: The EU-Africa dialogue [COM(2003) 316 final – Not published in the Official Journal].

Summary

The communication looks at how the EU can mainstream the new pan-African dimension into its cooperation and speaks of the need to build bridges between the different agreements that already exist between the EU and Africa: Cotonou, Euro-MED agreements and the Trade, Development and Cooperation Agreement with South Africa (TDCA). This could apply to the area of trade, to procurement rules for EU-funded projects, and to the programming of aid.

OBJECTIVES AND PRIORITY THEMES

The main aims of the EU-Africa dialogue are:

  • to strengthen political, economic and socio-cultural EU-Africa relations;
  • to eradicate poverty and attain the Millennium Development Goals in Africa, as well as implementing commitments recently made in international conferences (Doha, Monterrey and the World Summit on Sustainable Development);
  • to promote human rights, democracy and the rule of law in Africa.

The EU-Africa dialogue is organised around eight priority themes in order to achieve concrete outcomes:

  • human rights, democracy and good governance;
  • prevention and settlement of conflicts;
  • food security;
  • HIV/AIDS and other pandemics;
  • environment;
  • regional integration and trade;
  • external debt;
  • the return of illicitly exported cultural goods.

The communication takes each theme in turn, reports on the progress achieved and considers what future progress might be made.

Human rights, democracy and good governance

Dialogue on these themes is conducted around the topics of human trafficking, support for African institutions and the fight against corruption.

The Commission adopted a further communication in October 2003 on governance and development which proposes a new, more pragmatic approach to the promotion of good governance.

With a view to promoting good governance, the EU also proposed an action plan to combat illegal logging in its October 2003 communication on forest law enforcement and forestry management. Illegal logging in some countries has become such a chronic problem that it undermines the rule of law and principles of good governance.

The EU also wishes to deepen cooperation with Africa in the area of human resource development, especially universal primary education for both boys and girls, which is an essential element of the promotion of good governance.

Prevention and settlement of conflicts

The African Union gives priority to addressing conflicts, as shown by the decision taken by the African Union (AU) in July 2002 on setting up a Continent-wide Peace and Security Council and the adoption of a work programme on peace and security by all AU Member States.

In November 2003, the EU Council approved a draft decision on the financing of a Peace Facility for Africa from the European Development Fund (EDF) in response to a request made by the AU summit in Maputo in July 2003. This initiative, designed to support African institutions and measures to promote peace-keeping, will require cooperation between the AU, African regional organisations, the EU and the United Nations.

It is also essential to include measures to improve governance of natural resources within the framework of the EU-Africa dialogue on conflict prevention. Wars are actually waged to gain control of valuable resources for the purposes of private gain and natural resources, which could be exploited to raise money for the public purse, have frequently been used to fund and prolong armed conflict. This phenomenon is now acknowledged as being a major cause of conflicts in Africa.

Food security

The EU-Africa dialogue adopted a joint document reflecting a shared understanding of food security and the role of food aid which provided a basis for developing common positions in the areas of biotechnology, sanitary and phytosanitary standards, animal diseases and agricultural research.

The future dialogue should focus more on the political dimensions of food security, tackling such issues as access to productive resources (land, water) and equity.

HIV/AIDS and other pandemics

The EU and the countries of Africa agree that there is a need to strengthen health systems in African countries within a comprehensive framework of prevention, treatment and care and to increase health financing by the national governments and the international donor community. They also agree on the need for a joint approach in the areas of tiered pricing arrangements, technology transfer and local production so as to improve access to affordable medicines.

Environment

While the fight against drought and desertification is considered the main priority, other priorities under this heading include:

  • international environmental governance;
  • cooperation in preparing national strategies;
  • the link between poverty and the environment;
  • the regional dimension of environmental issues;
  • strengthening the capacity of the African countries to negotiate and implement international environmental agreements;
  • jointly looking for ways to improve the Global Environmental Facility;
  • integrated water resources management;
  • the prevention of natural disasters.

Note the EU Water Initiative which promoted the setting up of a European Water Facility to help give people in the African Caribbean and Pacific States (ACP) access to safe drinking water and adequate sanitation. Similarly, the creation of a European Energy Facility for ACP countries demonstrates the commitment of the EU to supporting the provision of adequate, affordable, sustainable energy services.

Mainstreaming of environmental issues into poverty eradication efforts should be a basic principle in EU-Africa cooperation considering that environmental protection is not a limitation to development but the base for sustainable livelihoods.

Regional integration and trade

Since the first EU-Africa summit, the EU has stepped up its support for regional integration by contributing to the integration of African countries into the world economy.

The Cotonou Agreement, signed in June 2000, for example, attaches a high priority to promoting regional cooperation and integration. It made substantial changes to the existing system to bring it into line with World Trade Organisation (WTO) rules and to allow the ACP States to participate fully in international trade. October 2003 saw the opening of negotiations on new regional economic partnership agreements with CEMAC (the Economic and Monetary Community of Central Africa) and ECOWAS (the Economic Community of West African States).

The EU and Africa will continue their cooperation and regular dialogue on WTO matters notably in the context of the Doha Development Agenda with a view to mainstreaming the development dimension in all areas of negotiations.

External debt

This sensitive issue has generated considerable debate and arguments on either side. As a contribution to the dialogue on debt, the Commission has decided to finance a study that will investigate the sustainability of the heavily indebted poor countries (HIPC) initiative. The Commission will ensure that the study reflects the views of the Member States, African countries, World Bank/IMF and other interested partners. Once this study is completed, the Commission is willing to table the relevant elements as a contribution to the EU-Africa dialogue.

The return of illicitly exported cultural goods

A set of guiding principles and concrete recommendations for action has been drawn up in the framework of the EU-Africa dialogue. The EU has established a preliminary inventory of all relevant ongoing cooperation activities between EU and African stakeholders.

The dialogue fosters adherence by all countries in the EU and Africa to the relevant international conventions, in particular the 1970 UNESCO Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property and the 1995 UNIDROIT Convention on Stolen or Illegally Exported Cultural Objects.

IMPROVING THE QUALITY OF THE DIALOGUE

The communication also highlights ways in which Europe and Africa could initiate a more flexible, simplified, direct and political dialogue.

Potential lines of action are envisaged for strengthening institutional ties between the European Community and the AU:

  • at senior official level;
  • in bi-regional working parties;
  • between the AU and the EU Heads of Mission based in Addis Ababa in the framework of the regular dialogue and coordination for peace and security;
  • between the Brussels-based African Heads of Mission;
  • and, lastly, between the AU/EU Commissions.

Background

The dialogue at continental level between the EU and Africa began in Cairo in April 2000 at the first EU-Africa summit. The aim of the dialogue is to build a strategic partnership with the whole continent based on shared objectives and common values. These can be found in the Treaty of the European Union, the Cotonou Agreement and the Barcelona process, as well as in the Constitutive Act of the African Union (AU), created in 2002, and in the manifesto of NEPAD, the New Partnership for Africa’s Development, launched in 2001.

At a crucial point in time for EU-Africa relations, this communication takes stock of the dialogue between the two parties and proposes ways of taking it forward.

The EU Role in Global Health

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The EU Role in Global Health

Outline of the Community (European Union) legislation about The EU Role in Global Health

Topics

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

Development > Sectoral development policies

The EU Role in Global Health

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 – The EU Role in Global Health [COM(2010) 128 final – Not published in the Official Journal].

Summary

The Commission presents principles to improve action undertaken by the European Union (EU) as regards protecting world health.

Health protection in non-Member States of the EU aims mainly at preventing health risks and reducing inequality of access to care. In addition, action in this area must take into account a number of social, economic and environmental factors.

Improving global governance

The Commission recommends better coordination of the different action undertaken by States or groups of States, at:

  • global level, in order to defend a single position within the World Health Organization (WHO) and the United Nations (UN);
  • regional level, to develop exchange and networks between neighbouring States;
  • national level, to support public policies and the control of public funding, as well as interaction with other areas (such as education, youth empowerment, the family, etc.).

Developing universal health coverage

Universal coverage of health services should be established in the poorest countries. In this regard, the EU should increase its public development aid (PDA), but also reinforce its effectiveness and predictability. The Commission also recommends:

  • concentrating aid to serve the most fragile populations and countries;
  • strengthening the effectiveness and equity of health systems, as well as their functioning in terms of workforce, access to medicines, infrastructure, logistics and decentralised management;
  • having recourse to global initiatives and existing international financial institutions, but also to innovative funding.

Increasing policy coherence

Key issues in health policy should be taken into account in other areas, such as:

  • trade, in particular with regard to intellectual property rights, access to essential medicines, opening up generic medicine competition and combating counterfeiting;
  • managing migration, which should not undermine the availability of health professionals in developing countries;
  • defence and security, in order to better address fragile contexts and to provide an early response to international health risks;
  • food safety, food aid and nutrition, through public policies and the monitoring of nutritional status in the population;
  • climate change – the objective of health protection should be taken into account when allocating new funding.

Particular attention should also be paid to the fields of education and youth.

Research and innovation

Access to health services, medical technologies and medicines should benefit all. Research and innovation strategies should therefore be directed towards:

  • strengthening the research process overall – innovation, implementation, access, monitoring and evaluation;
  • collecting comparable data and statistics at global level, by collaborating with national and international organisations working on world health (WHO, OECD, etc.);
  • improving the dissemination of factual information, including risks, and the safety of food, feed, pharmaceuticals and medical devices.

Optimising skills

The EU must put in place mechanisms to optimise:

  • European action in EU countries and external countries, particularly within a platform to exchange information and through the development of common positions between EU countries and the Commission;
  • monitoring of European aid and implementation of the EU Code of Conduct on Division of Labour in the area of health;
  • dialogue between the key global players, in partnership with UN agencies and international financial institutions.

Context

The adoption of the Millennium Development Goals (MDGs) in 2000 has led to progress being made with regard to reducing global poverty. However, progress in developing countries is still uneven and often insufficient.

The international community has therefore enhanced its efforts regarding the three MDGs relating to health (reducing child mortality, improving maternal health, and combating disease – in particular HIV/AIDS and malaria).

Tax governance in developing countries

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Tax governance in developing countries

Outline of the Community (European Union) legislation about Tax governance in developing countries

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

Development > Sectoral development policies

Tax governance in developing countries

Document or Iniciative

Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee of 21 April 2010 – Tax and Development Cooperating with Developing Countries on Promoting Good Governance in Tax Matters [COM(2010) 163 final – Not published in the Official Journal].

Summary

The improvement of economic and social conditions in developing countries is related to good tax governance and the strengthening of their tax systems. Furthermore, good international financial governance should allow funding destined for development to be mobilised and used more effectively.

Thus, the European Union (EU) encourages both tax cooperation with developing countries and the fight against tax evasion and avoidance.

Tax governance in developing countries

Development aid policies should contribute to the effectiveness of tax systems and an increase in tax revenue in EU partner countries. Taxes are essential for sustainable development, the legitimacy of the State, economic stability, and the financing of public services and infrastructures.

However, developing countries are subject to several types of difficulty, particularly due to:

  • the fragility of their economic structures and their low level of competitiveness;
  • their political instability, bad governance and the weakness of the rule of law;
  • bad tax management and unequal tax burden distribution among taxpayers;
  • the weakness of tax administrations lacking means and skills.

Furthermore, in the context of globalisation, several international factors form barriers to the effectiveness of national tax systems:

  • the implementation of domestic tax rules becomes difficult in a world with a high geographical mobility of taxpayers, high volumes of trade and capital flows and the use of new technologies for fraudulent purposes;
  • the transition from revenue systems largely dependent on customs revenue to broader and more modern ones;
  • a wish to attract sustainable foreign investments;
  • the use of bad tax practices, including in developed countries.

In order to overcome these tax reform difficulties, partner countries should:

  • distribute the tax burden fairly, particularly by balancing direct and indirect taxes;
  • take account of the specific nature of the informal economy (i.e. non-structured economic activities) and support micro and small enterprises;
  • stabilise the legal framework and improve the transparency of tax systems;
  • enhance the skills and capacities of administrations collecting taxes and reporting expenditure.

Transparency and international tax cooperation

The international context should also be improved by promoting and adopting international principles and standards as regards transparency and the exchange of tax information. This action should be taken in order to combat tax evasion and avoidance, money laundering, corruption and the financing of terrorism. It is also important to enhance the participation of developing countries in international fora dealing with tax governance issues.

The Commission also wishes to carry out its action as part of regional cooperation partnerships with the African, Caribbean and Pacific (ACP) countries, Latin American and European Neighbourhood regions.

Using European Union instruments

Each partner country is to define their policies and reforms. Development aid should be adapted to each country according to its economic situation, international position and policies. Several aid instruments can be used to support these reforms:

  • budget support programs and public finance management tools;
  • technical cooperation with tax administrations;
  • regional cooperation with the African, Caribbean and Pacific (ACP) countries, Latin American and European Neighbourhood regions;
  • support for the capacities of oversight bodies, national parliaments and Non-State Actors in developing countries in the field of tax.

These instruments must be established as part of existing programmes (the European Development Fund (EDF), the Development Cooperation Instrument (DCI), or the European Neighbourhood Policy and Partnership Instrument (ENPI)).

In addition, the Commission encourages donor coordination in each partner country, as well as closer international cooperation when international standards on tax cooperation are defined. These standards should take into account the needs and capacities of developing countries.

Context

The Commission’s action is in line with the Monterrey Consensus and the Doha Declaration adopted by the UN.

The second amendment to the Cotonou Agreement takes account of good tax governance principles.

Land policy in developing countries

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Land policy in developing countries

Outline of the Community (European Union) legislation about Land policy in developing countries

Topics

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

Development > Sectoral development policies

Land policy in developing countries

Document or Iniciative

Communication from the Commission to the Council and the European Parliament of 19 October 2004 – EU Guidelines to support land policy design and reform processes in developing countries [COM(2004) 686 final – Not published in the Official Journal].

Summary

The European Union (EU) supports land policy reforms in developing countries. To this end, the Commission provides guidelines to target the action of the Commission and EU Member States in this area.

Land reforms give rise to public policies on the distribution and use of agricultural land. Such reforms have implications in several areas, such as the fight against poverty, environmental management, market regulation, good governance, and democracy. They should be based on national consensus, and supported by rural organisations.

Land policy support

The EU focuses on certain aspects of land reform, in order to:

  • guarantee the security of land rights, through effective institutions and by taking into account both traditional and informal land access schemes;
  • analyse existing rules and practices, as well as land conflicts and modes of transfer;
  • establish innovative land access schemes, beyond the allocation of land rights, and by taking into account village, family or individual rights;
  • support the reform of land administrations, in particular to implement simple and transparent procedures, opportunities for appeal in the event of dispute, and actions to increase public awareness;
  • promote land rental markets, which are more accessible to the poor and less susceptible to the risks associated with farming. Such measures are subject to the existence of appropriate contractual rights.

Development assistance

Official Development Assistance allocated by the European Union and its Member States can be used to support public debate, and the preparation and implementation of reforms. It should also facilitate the implementation of thematic projects (research, environment, social development, etc), and reform evaluation actions.

National reform processes should include civil society and minority groups in a participatory process. Furthermore, reforms should focus primarily on areas where inequality persists.

The EU should also participate in the creation of partnerships, in order to prioritise common approaches, the sharing of experience, as well as facilitating coordination with international donors.

Finally, to be effective, European assistance should comply with certain principles:

  • providing solutions that are specific to the local social and institutional context;
  • establishing partnerships with the competent public authorities and stakeholders from civil society;
  • conducting regular political dialogue and encouraging coordination with the competent authorities;
  • supporting long-term processes;
  • supporting equality between men and women concerning the control over and use of land resources;
  • conducting public information and awareness-raising campaigns;
  • supporting research;
  • protecting the most deprived members of the population, and in particular indigenous peoples.

Supporting developing countries in coping with the crisis

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Supporting developing countries in coping with the crisis

Outline of the Community (European Union) legislation about Supporting developing countries in coping with the crisis

Topics

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

Development > Sectoral development policies

Supporting developing countries in coping with the crisis

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 8 April 2009 – Supporting developing countries in coping with the crisis [COM(2009) 160 final – Not published in the Official Journal].

Summary

Developing countries are particularly vulnerable to the effects of the international financial crisis. Development policies have improved their economic situation, but their resilience capacity remains limited.

Their monetary and budgetary policies are particularly constrained by inflation peaks, exchange rate volatility, deteriorating external balances, rising food prices and increasing energy costs. The European Union (EU) has chosen to support the countries that are most vulnerable to the effects of the crisis as a priority. These countries may be identified by combining several criteria corresponding to the main channels by which the crisis has been spread to developing countries, in particular:

  • dependence on export revenues and the degree of integration into world trade;
  • dependence on international financial flows and transfers;
  • capacity to react in response to the crisis.

Funding aid

The EU provides the largest portion of Official Development Aid (ODA), almost EUR 50 billion or 59 % of ODA overall. Its contribution is increasing, but Member States should nevertheless commit to add a further EUR 20 billion of aid in order to meet their objectives set for 2010 (0.56 % of Gross Domestic Income).

This increase in ODA is essential for participating in economic recovery and meeting the Millennium Development Goals (MDGs). Aid must be supplemented by the use and mobilisation of other development resources and instruments. This is the case for export credits, investment guarantees, technology transfer and innovative development funding mechanisms (e.g. voluntary solidarity levies, such as the airline tax applied by some Member States).

The Commission recommends that Member States adopt counter-cyclical development policies consisting of:

  • adapting 2009 and 2010 strategies and programmes, and re-directing EIB loans to key sectors in order to eliminate the crisis and boost economic activity (infrastructures, energy, activities related to climate change, green growth and the financial sector);
  • accelerating payment and making advances on aid commitments and budgetary support for all countries, in particular for those in a situation of emergency;
  • giving macro-economic assistance, for ENP countries, accession and pre-accession countries, in cooperation with the IMF.

Aid effectiveness

The fragmentation of agencies and bilateral or multilateral donors, and the lack of stability and predictability of funding have a high cost. It would be possible to make gains in effectiveness each year, which could translate into billions of euros allocated to supporting reforms, projects and action. The EU has adopted a European programme for aid effectiveness and a Code of Conduct on the Division of Labour. In 2008, it committed to the Accra Agenda for Action and plays an essential role in rationalising international development aid architecture.

The Commission proposes to accelerate the implementation of these programmes, as well as the application of the Commission Recommendations aimed at ensuring maximum impact for EU aid.

Recovery measures

In order to combat the social effects of the crisis and to contribute to the MDGs, particular support must be given to social protection systems and labour markets. Thus in 2009 and 2010, almost EUR 500 million will be committed under the European Development Fund (EDF), in order to protect public spending in essential sectors. This funding is to be implemented through:

  • the FLEX system which allows export losses to be compensated for according to the years preceding the crisis;
  • the additional and temporary “vulnerability FLEX” system, established expressly to respond more quickly and in a targeted way to the crisis in the most vulnerable countries.

Growth and employment are also promoted by the funding of infrastructures (EU-Africa Trust Fund), through support for agriculture and the creation of links between places of production and sale, by means of measures to foster private trade and the increase of credit facilities (in particular, the EIB’s investment facility, the Facility for Euro-Mediterranean Investment and Partnership (FEMIP), and the ENP investment facility for Eastern Europe).

The support provided by the EU in the context of the crisis also includes measures adopted to meet the food crisis (particularly the Food Facility with a budget of EUR 1 billion) which persists in many countries.

Recovery strategies take into account objectives for sustainable development and tackling climate change, including in the Least Developed Countries (LDCs).

Sustainable economic development necessitates the strengthening of economic and financial governance, including tax governance. Fighting corruption and the introduction of a healthy macro-economic and regulatory environment should be the key elements in political dialogue between the EU and its partner countries.

The EU should also work towards a better balance of the global governance system (particularly within the United Nations, the International Monetary Fund (IMF) and the World Bank), in order to make these authorities more complementary and to ensure greater representation for developing countries.

Compulsory licensing system for the production and export of generic medicinal products to developing countries

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Compulsory licensing system for the production and export of generic medicinal products to developing countries

Outline of the Community (European Union) legislation about Compulsory licensing system for the production and export of generic medicinal products to developing countries

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

Development > Sectoral development policies

Compulsory licensing system for the production and export of generic medicinal products to developing countries

Document or Iniciative

Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems.

Summary

PROCEDURE AND CONDITIONS FOR THE GRANTING OF COMPULSORY LICENCES

The Regulation lays down a procedure allowing undertakings wishing to manufacture generic pharmaceutical products for export to apply to the national authorities for the granting of a “compulsory licence” from a patent holder who has exclusive rights to the products in question and their sale.

The Regulation does not impose any restrictions with regard to the pharmaceutical products and illnesses covered. A “pharmaceutical product” is any product of the pharmaceutical sector, including medicinal products, as defined by the Community Code relating to medicinal products for human use.

Eligible importing members

Compulsory licences are granted where the products concerned are intended for export to eligible importing countries with public health problems.

The Regulation identifies the following categories of eligible importing countries:

  • the least-developed countries (LDCs);
  • World Trade Organisation (WTO) members, other than the LDCs, which have notified the Council for TRIPS (Trade-Related Aspects of Intellectual Property Rights) of their intention to use the system as importers;
  • non-WTO members which are listed as low-income countries by the Development Assistance Committee (DAC) of the Organisation for Economic Cooperation and Development (OECD) and have notified the Commission of their intention to use the system as importers.

Competent authorities

It is the responsibility of the competent authorities of the Member States to order that a compulsory licence be granted. The competent authorities are those with the power to grant compulsory licences in accordance with national patent law, unless otherwise provided for by the Member State. The European Commission must be notified of such alternative provisions.

Applicants for compulsory licences

Anyone may apply for a compulsory licence to the competent authorities of the Member State(s) where the patents are applicable.

If the applicant for a compulsory licence has submitted applications for the same product to several countries, this must be mentioned in each application with an indication of the quantities and importing members concerned.

The applicant must prove that he has received a specific request, either from the importing country or its authorised representative, or from a health organisation (be it non-governmental, a United Nations body or another international organisation) acting with the formal authorisation of one or more importing countries.

Rights-holders

The competent authority must notify the rights-holder without delay of the application for a compulsory licence.

Admission requirements for applications

The competent authorities must verify that the basic admission requirements for making use of the system have been satisfied.

The competent authority must therefore check that each WTO-member importing country mentioned in the application has notified the WTO in respect of each of the products covered by the application. For importing countries that are not WTO members, the competent authority must check that the Commission has been notified. The competent authority must also check that the quantities indicated in the application are no greater than those which were notified to the WTO or the Commission.

In this notification, the importing countries (except LDCs) must in particular show that their pharmaceutical manufacturing capacity as regards one or more specific products is insufficient or non-existent.

The applicant for a compulsory licence must also provide evidence that he has endeavoured to obtain authorisation from the rights-holder and that these endeavours have not been successful within a period of thirty days before submitting the application. This rule does not apply in the event of national emergency, nor in cases of public, non-commercial use.

Conditions for granting a compulsory licence

The competent authority may refuse to grant a licence if one of the conditions is not met. Once granted, licences are non-exclusive and non-transferable and must be notified to the Council for TRIPS through the intermediary of the European Commission.

The compulsory licence is strictly limited to the quantities needed by the importing country or countries indicated in the application and to the manufacturing of the product in question for export and distribution there.

Thus, no product manufactured or imported under a compulsory licence may be sold or marketed in any country other than those indicated in the application. This does not apply to exports to partner countries in a regional trade agreement which have the same health problem.

Products manufactured under the licence must be clearly marked by a label or special marking to distinguish them from those manufactured by the rights-holder, provided that this is physically possible and does not have a significant impact on the price.

If the products covered by the compulsory licence are patented in the importing countries indicated in the application, they may be exported only if these countries have issued a compulsory licence for the import, sale or distribution of the products.

Lastly, the holder of the licence must make a suitable payment to the rights-holder. This will be calculated by the competent authority on the basis of the economic value of the authorised use under the licence and of non-commercial factors in the granting of the licence. In the event of a national emergency or in the case of public, non-commercial use, on the other hand, the payment is fixed at a maximum of 4 % of the total price paid by the importing country.

MEASURES TO PREVENT REIMPORT INTO THE EU

To ensure that the medicinal products do not fail to reach those who need them, the Regulation bans their reimport into the EU and calls on customs authorities to take measures against reimported products.

The customs authorities thus have the possibility of detaining any product suspected of being reimported into the Community. They may not do so for more than ten working days.

Throughout the suspension procedure, account will be taken of national provisions on the protection of individual data, commercial and industrial secrecy, and professional and administrative confidentiality.

If the competent authority finds after investigation that the products were to be imported into the Community, it will ensure that they are seized and disposed of in accordance with national legislation.

These provisions do not apply, however, to goods of no commercial value contained in travellers’ personal luggage and intended for their personal use.

TERMINATION AND REVIEW OF A COMPULSORY LICENCE

A patent holder may make use of national procedures for appealing against a decision and for disputes concerning compliance with licence conditions.

A licence may be terminated if the holder fails to comply with the conditions. Following termination, the holder must arrange within a reasonable period of time for the products in his possession, custody or control to be dispatched at his expense to the countries that need them.

Where quantities of the pharmaceutical products have become insufficient to meet its needs, the importing country must notify the competent authority. The latter may modify the conditions of the licence at the holder’s request.

EVALUATION OF MEDICINAL PRODUCTS

In order to be sure that the exported medicinal products are safe and effective, applicants for a compulsory licence for a medicinal product may make use of the EU procedure for a scientific opinion, or of other similar procedures under national legislation.

In addition, if the product in question is a generic version of a standard medicinal product which is or has been authorised in the EU, the protection periods laid down in Regulation (EC) No 726/2004 and Directive 2001/83/EC do not apply.

Background

Most national legal systems do not currently authorise compulsory licences for export because, until recently, the World Trade Organisation TRIPS Agreement provided for compulsory licences “predominantly for the supply of the domestic market” only.

As a result of the Doha Declaration on trade and health adopted in November 2001, a decision was taken to tackle the difficulties caused by this restriction for developing countries that lack manufacturing capacity.

After lengthy negotiations, the members of the WTO agreed on 30 August 2003 on the principle of a waiver allowing these countries access to those generic medicinal products of which they were in urgent need.

This Regulation underlines the EU’s status as a pioneer in guaranteeing poor countries access to reasonably-priced medicinal products.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Regulation (EC) No 816/2006 [adoption: codecision COD/2004/0258]

29.6.2006

–

OJ L 157 of 9.6.2006

 

Governance in the consensus on development

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Governance in the consensus on development

Outline of the Community (European Union) legislation about Governance in the consensus on development

Topics

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

External relations > Relations with third countries > Asia

Governance in the consensus on development

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 30 August 2006 – Governance in the European consensus on development – Towards a harmonised approach within the European Union [COM(2006) 421 final – Not published in the Official Journal].

Summary

Within the framework of the European consensus on development, which stressed the importance of integrating the concept of democratic governance into every sectoral programme, the Commission is proposing to the European Union (EU) a common approach to governance.

New approach

The Commission underlines the importance of approaching governance from a wider angle, taking into account all its dimensions (political, economic, environmental and social). Good governance means more than tackling corruption; it includes such things as access to health, education and justice, pluralism in the media, the functioning of parliament and the management of public accounts and natural resources.

In order to encourage developing countries to step up their efforts to reform, the approach proposed by the Commission is based on political dialogue, respect for the undertaking of reform by governments and the citizens of partner countries, and incentives. The identification of reforms and support measures that are suitable for each country requires an evaluation of governance in the country concerned. This evaluation is carried out using a participatory approach that encourages local players (such as the government and civil society) to develop their own analytical tools and skills.

Assuming that conditions for suitable democratic control, financial management and institutional development have been created, budgetary assistance helps to strengthen governance and institutions at central and local level. The Commission underlines its increased use and the fact that this makes it possible to tackle the problems of lack of political legitimacy and the capacities which characterise several developing countries, fragile States in particular.

The effectiveness of this new approach is dependent on the capacity of donors to act in a coordinated and harmonised manner, with respect to governance analysis tools and response strategies in particular. Within this context, Member States and the Commission have made progress towards common programming and have drawn up a code of conduct on complementarity and the division of labour.

African, Caribbean and Pacific (ACP) countries

Governance is already included in the regular political dialogue with ACP countries, and support for this will be stepped up. When the 9th European Development Fund (EDF) was being programmed, the sum of €870 million (or 10% of all programmable funding) was granted for projects in this field. In addition, under the 10th EDF €3 billion will be set aside for incentives, divided between national funding (2.7 billion) and a regional fund (300 million). Country access to this reserve is dependent on the outcome of a dialogue with the Commission concerning its own governance plan. In this context, a governance profile will be created for each country.

Moreover, governance will be integrated as a cross-cutting theme in all sectors of cooperation. This will be accompanied by the creation of new ways of taking into account the new provisions of the Cotonou agreement and the regional strategies adopted for Africa, the Caribbean and the Pacific.

In Africa, governance has also been mainstreamed in dialogue and cooperation between the Pan-African institutions and the EU. The Commission is proposing increased support for the institutions of the African Union and the African Peer Review Mechanism (APRM) of the New Partnership for Africa’s Development (NEPAD).

Other developing countries

The EU supports the promotion of democracy, human rights and good governance in all other developing countries, according to strategies based on the specific features of each region.

In cooperation with countries covered by the neighbourhood policy, priority areas for financial assistance from the EU are selected on the basis of action plans focused on governance and adopted jointly with the countries concerned. Progress made in the various areas of governance is regularly monitored. Moreover, governance is supported by cooperation mechanisms such as twinning, TAIEX and the SIGMA initiative, which were originally developed for the purposes of enlargement. Additional support for the promotion of political and economic reforms in these countries is now offered by the new “Governance” facility.

In a 2005 Communication, the Commission undertook to support governance in Latin America. It therefore intends to continue to support the modernisation of government in the region, using an approach tailored to the needs of individual countries, which vary according to their stability. The Commission will continue, moreover, to support regional integration which, since it involves establishing and complying with common rules, is a powerful vector for good governance in economic and trade matters.

In Asia, the EU will continue its dialogue with China and India. Political dialogue at regional and bilateral levels with the countries of in central Asia is bolstered by the presence of a special rapporteur on democratic governance. Moreover, governance features in the cooperation with the Association of South-East Asian Nations (ASEAN) and in the informal dialogues of the Asia-Europe meetings (ASEM). In the programming for the period 2007-2013, governance is a cross-cutting issue in all cooperation activities in the countries of the region and also a focal sector in the cooperation with several of them.

Associated Acts

Communication from the Commission to the Council, the European Parliament and the European Economic and Social Committee of 20 October 2003: Governance and development [COM(2003) 615 final- Not published in the Official Journal].

Humanitarian Food Assistance

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Humanitarian Food Assistance

Outline of the Community (European Union) legislation about Humanitarian Food Assistance

Topics

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

Humanitarian aid

Humanitarian Food Assistance

Document or Iniciative

Communication from the Commission to the Council and the European Parliament of 31 March 2010 Humanitarian Food Assistance [COM(2010) 126 final – Not published in the Official Journal].

Summary

The Commission defines the strategic framework in which the European Union (EU) provides food assistance in the event of humanitarian crises outside its territory. This new strategy should allow the effectiveness of assistance and the joint work of all actors involved to be improved.

Humanitarian food assistance has the main aim of saving and preserving lives, protecting livelihoods and increasing resilience for populations facing ongoing or future food crises. The EU’s action also aims at meeting a series of specific objectives:

  • ensuring the availability, access to and consumption of adequate, safe and nutritious food;
  • protecting food production and marketing systems;
  • strengthening the international system to improve the effectiveness of assistance.

However, operations must not:

  • make populations dependent upon the relief system;
  • disrupt the functioning of commercial markets;
  • expose beneficiaries to risk in receiving assistance;
  • have too much impact on the environment and natural resources.

Initiation of assistance operations

The Commission can trigger a humanitarian food assistance response where:

  • emergency rates of mortality or acute malnutrition have been reached, or will be reached according to forecasts, due to lack of food;
  • there are serious threats to the lives of the population or risks of extreme suffering, due to a lack of livelihood or bad strategies for coping with the crisis (i.e. in particular the sale of productive assets, migration, or insecure survival practices, etc.).

Nevertheless, the Commission can intervene as soon as a crisis begins, without waiting for extreme risks for the population to occur or for a disaster to be officially declared.

It can also deal with situations of chronic food insecurity by associating humanitarian intervention with development actions. This is only possible if:

  • the situation presents an imminent humanitarian risk of significant severity;
  • other actors cannot act;
  • the action may have a positive impact in a short time.

Operations are gradually halted when indicators are stable below emergency levels. They are also halted when other donors or non-humanitarian stakeholders are able to meet the needs of the population for a sustained period.

Food and nutritional needs

Operations aim first of all at the timely supply of food. However, humanitarian food assistance may also intervene in several food-related sectors, such as agriculture and health.

Furthermore, populations should have access to safe and well balanced food, of sufficient quantity and quality. The type of food proposed should, if possible, conform to local dietary preferences.

Finally, populations should be made aware of nutrition and appropriate feeding practices.

Additional strategies

The Commission wishes to develop links between humanitarian assistance, the strategy for relief, rehabilitation and development (LRRD) and the strategy for disaster risk reduction (DRR). This approach necessitates long-term support and effective coordination among those involved in humanitarian assistance and development.

The EU also promotes better collaboration between international actors and a reinforcement of global governance.

Context

This strategic framework complies with the European Consensus on Humanitarian Aid. It is presented in conjunction with the Communication on food security and development.

European Development and External Assistance Policies: 2008 Report

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European Development and External Assistance Policies: 2008 Report

Outline of the Community (European Union) legislation about European Development and External Assistance Policies: 2008 Report

Topics

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

Development > General development framework

European Development and External Assistance Policies: 2008 Report

Document or Iniciative

Report from the Commission to the Council and the European Parliament of 30 June 2009 – Annual Report 2009 on the European community’s development and external assistance policies and their implementation in 2008 [COM(2009) 296 final – Not published in the Official Journal].

Summary

2008 was marked by soaring food and energy prices and the global financial crisis. Despite these unfavourable conditions, the European Union (EU) demonstrated its ability to meet its commitments and to respond to the new needs of developing countries.

The EU is a key partner on the global stage, particularly with regard to issues such as climate, energy, trade and achieving the Millennium Development Goals (MDGs). This Report highlights the importance of making European development policies coherent (BG) (CS) (DA) (ET) (EL) (FR) (GA) (LV) (LT) (HU) (MT) (NL) (PL) (PT) (RO) (SK) (SL) (FI) (SV), whilst taking into account the growing interdependence between the EU and its partners.

In 2008, the Commission assessed the progress made towards achieving the MDGs at mid-way and set new milestones for 2010. The Commission also increased efforts to integrate issues such as gender equality, the environment and the rights of children and indigenous people into the development process. Furthermore, the Commission considers good tax and democratic governance to be essential for successful reforms.

More and better aid

In order to offset the impact of soaring prices, the EU created a Food Facility (FR) with a budget of EUR 1 billion for the period 2008-2010. In 2008 the Commission also increased the budget for humanitarian aid by EUR 140 million and called up EUR 200 million from the European Development Fund (EDF).

The EU renewed its commitment to increasing overall development assistance in coming years. The volume of assistance has increased by 90 % since 2001, reaching EUR 9.33 billion in 2008.

Aid efficiency must also be improved. In this context, it involves:

  • prioritising the channelling of aid through country systems to reinforce local ownership of projects and reduce transaction costs;
  • increasing the predictability of aid, through setting up MDG contracts to provide longer-term aid. The first countries to benefit from these contracts were Burkino Faso, Ghana, Mali, Mozambique, Rwanda, Uganda and Zambia;
  • adopting a strategy of long-term aid, targeted towards those partner countries achieving results and good budget management.

The Report highlights an increase in budget support to 39 % (EUR 3.68 billion from EU and EDF budgets), in the form of funds transferred to the national treasury of the beneficiary country. This is gradually replacing direct project-linked funding, provided that public finance management in the beneficiary country has received a positive assessment. The Commission is working to improve eligibility criteria and risk assessment.

In 2008, the Commission began reforms to increase its capacity for action in terms of technical cooperation and to strengthen its development project implementation units. This reform was supported by the launch of “Capacity4Dev”, an on-line interactive platform.

Partnership steps

More effective aid must be based on donor coordination and the sharing of experience. This approach prevailed in the distribution of aid in Afghanistan, in the Occupied Palestinian Territory using the funding instrument PEGASE and in Iraq using the funding instrument IRFFI.

The Commission has continued its cooperation with the United Nations, the World Bank and all of the donors in planning recovery operations after a crisis, disaster or conflict has occurred.

The Commission is preparing a new strategy in favour of local authorities participating in development cooperation actions.

Assessment of actions taken

In terms of development cooperation, the EU carries out results-oriented actions. In order to increase the effectiveness and impact of its aid, the Commission assessed geographical and thematic programming and aid delivery modalities. It concluded that greater visibility of actions, synergy between activities and coherence between country and regional aid is required.