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Subsidiarity

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Subsidiarity

Outline of the Community (European Union) legislation about Subsidiarity

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Institutional affairs > Building europe through the treaties > The Amsterdam treaty: a comprehensive guide

Subsidiarity

One of the major objectives of the Intergovernmental Conference on the revision of the Treaties was to bring the European Union closer to its citizens by enabling them to understand and influence European integration. A number of Community policies, such as those on consumer protection or employment, will be reformed with this specific goal in mind.

Subsidiarity was another major topic of discussion when the conference considered how better to meet the expectations of the people of Europe. To consolidate this principle, on which the efficiency of the European Union depends, a specific protocol has been annexed to the EC Treaty.

PROTOCOL ON THE PRINCIPLE OF SUBSIDIARITY

In October 1992, the Birmingham European Council confirmed that decisions should be taken as closely as possible to the citizens of the Union in accordance with Article 5 (ex Article 3b) of the EC Treaty. With this in mind, the Edinburgh European Council of December 1992 agreed an overall approach for applying the principle of subsidiarity (basic principles, guidelines, and procedures).

The Protocol on the application of the principles of subsidiarity and proportionality codifies the guidelines adopted by the Edinburgh European Council and gives them force in law. By this means the Member States intend to formalise a number of aspects relating to subsidiarity:

  • subsidiarity is a dynamic concept and the appropriate level for action may vary according to circumstances;
  • all legislative proposals will be accompanied by a statement on the impact of the proposed measure on the application of the principle of subsidiarity;
  • consistent with the proper achievement of the objective, the form of Community action should not be too restrictive (as far as possible, directives should be preferred to regulations);
  • subsidiarity should not undermine the powers conferred on the European Community by the Treaty, as interpreted by the Court of Justice.

The main condition for embarking on Community action is set out in the second paragraph of Article 5 of the EC Treaty, which states that the Community shall take action “only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the proposed action, be better achieved by the Community”. The Protocol cites three criteria for judging whether this condition has been fulfilled:

  • does the action have transnational aspects that cannot be satisfactorily regulated by the Member States?
  • would action by Member States or lack of action conflict with the requirements of the Treaty?
  • would action at Community level produce clear benefits?

Suitability of blood donors

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Suitability of blood donors

Outline of the Community (European Union) legislation about Suitability of blood donors

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

Public health > Threats to health

Suitability of blood donors

Document or Iniciative

Council Recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community [Official Journal L 203 of 21.7.1998].

Summary

Awareness

The Member States ought to make donors aware of:

  • the benefits to patients of blood and plasma donations;
  • the risk of infectious diseases being transmitted by blood and blood products, and the resultant need for a medical history, a physical examination and the testing of donations;
  • the reasons why they should not provide donations, in the interests of both their own health and the safety of recipients;
  • the possibility of asking questions and of withdrawing from the donation process at any time.

Information given to donors

Donors are given an assurance that they will be contacted by the blood collection centre if test results show evidence of any pathology.

Donors are informed of the measures taken to ensure the confidentiality of any information relating to their health and their donation. They have the option of requesting that the medical staff should not use their donation.

Information provided by donors

Donors should provide to the blood and plasma collection establishment the following details:

  • their identity, attested by a valid official document;
  • information on their health and medical history, including any behavioural characteristics that may affect the quality of the donation, by way of a written questionnaire and an interview with a trained medical staff member;
  • their signature on the said questionnaire, alongside that of the medical staff member conducting the interview; their agreement that their donation(s) may be used and their written consent confirming that they wish to continue with the donation process.

Identification/registration system

The Member States should ensure that an identification/registration system is set up for the purpose of:

  • identifying every collection establishment;
  • identifying prospective donors in such a way that verification is possible each time a donation is made;
  • future traceability of donations through the keeping of records on donors and prospective donors, ensuring unique identification with all the necessary guarantees of confidentiality;
  • allowing the inclusion of information relating to adverse donor reaction to a donation and reasons for preventing an individual from making a donation, whether temporarily or permanently, whilst ensuring confidentiality.

Donor suitability

The criteria for acceptance of donors should be clearly indicated in every donation centre and explained to the donors.

The Member States must ensure that a donation will not adversely affect the health of a future recipient or of the donor. A prospective donor’s suitability must be determined at each donation session, with steps being taken to prohibit or phase out the use of “replacement donors”. Moreover, a responsible physician is required to give his/her written authorisation at the final stage of determining the suitability of a prospective donor whose eligibility is questionable.

The Member States must take steps to exclude permanently or temporarily from the donation process persons who display any of the conditions and characteristics listed in sections B and C of Annex II.

The exclusion of any prospective donor, whether permanent or temporary, must be recorded in a file, indicating the reasons.

Confidentiality

The Member States must ensure the confidentiality and security of sensitive medical information about prospective donors. They are required to put in place procedures for resolving data discrepancies and to prevent the unauthorised disclosure of information, while ensuring the traceability of donations.

Protection of donors’ health

Annex III of the Recommendation sets out common standards for the protection of donors’ health, particularly as regards:

  • the maximum volumes of blood and plasma to be collected during a single donation and over a 12-month period;
  • the minimum time interval between donations.

Medical attention must be made available to the donor if the donation gives rise to an adverse event.

The Member States should ensure that a sample of every donation is tested for diseases transmissible by blood and that re-testing is carried out on blood samples found to be reactive in an initial screening test.

Encouragement of voluntary donation

The Member States should take all the necessary measures to encourage the voluntary and unpaid donation of blood and plasma.

Related Acts

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, and amending Directive 2001/83/EC [Official Journal L 33 of 08.02.2003].
This Directive lays down high standards of quality and safety for human blood and blood components throughout the Community, with the aim of putting in place a full set of binding rules across the entire “transfusion chain”.

Surveillance of budgetary policies

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Surveillance of budgetary policies

Outline of the Community (European Union) legislation about Surveillance of budgetary policies

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Economic and monetary affairs > Stability and growth pact and economic policy coordination

Surveillance of budgetary policies

Document or Iniciative

Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies [See amending acts].

Summary

This Regulation constitutes the preventive arm of the stability and growth pact. It aims to monitor and coordinate Member States’ budgetary policies, by way of a preventive measure to ensure budgetary discipline within the European Union.

To this end, the Regulation provides for a European Semester at the start of each year to assist Member States in putting in place healthy budgetary policies. Member States submit to the Commission stability programmes (for Member States in the euro zone) and convergence programmes (for Member States outside the euro zone) in which they adopt medium-term budgetary objectives. These programmes are assessed by the Commission and are the subject of specific Council recommendations for each State.

European Semester for economic policy coordination

The European Semester comprises a six-month period during which Member States’ budgetary policies are examined.

At the start of the Semester, the Council shall identify the key economic challenges for the European Union (EU) and provide Member States with strategic policy guidelines to be followed.

Subsequently, and on the basis of these guidelines, Member States shall establish:

  • their stability or convergence programmes under this Regulation;
  • their national reform programmes, in line with broad guidelines for economic policy and guidelines for employment policies.

At the end of the European Semester and following an assessment of the programmes, the Council sends recommendations to each Member State. Based on the Commission’s Opinion, the Council thus makes known its assessments before Member States draw up their final budgets for the following year.

Medium-term budgetary objectives

Each Member State has a medium-term deficit objective for its budgetary position, defined in structural terms. The medium-term objectives differ between Member States: they are more stringent where the level of debt and estimated costs of an ageing population are higher.

For the Member States that have adopted the euro and for those participating in the ERM 2 at over – 1 % of GDP, the medium-term objectives may be revised when a major structural reform is undertaken or every three years, when forecasts are published enabling the estimated costs of ageing populations to be updated.

Multilateral surveillance: stability and convergence programmes

The stability and convergence programmes serve as a basis for multilateral surveillance by the Council of the EU. This surveillance, provided for in Article 121 of the Treaty on the Functioning of the EU should prevent, at an early stage, the occurrence of excessive public deficits and promote the coordination of economic policies.

Each Member State must present the Council of the EU and the Commission with a stability programme (for Member States in the euro zone) or a convergence programme (for Member States outside the euro zone).

Stability or convergence programmes must include the following information:

  • the medium-term budgetary objective, an adjustment path for achieving the objective, government balance as a percentage of GDP, the foreseeable trend for the government debt ratio, the growth rate planned for government expenditure, the growth path of government revenue at unchanged policy, and quantified discretionary revenue measures. In addition, convergence programmes have to state the relationship between these objectives and price and exchange rate stability, as well as the medium-term objectives of monetary policy;
  • information on implicit liabilities related to ageing, and contingent liabilities (such as public guarantees) with a potentially large impact on government accounts;
  • information on the consistency of the programmes with the broad economic policy guidelines and the national reform programmes;
  • the main assumptions underlying the economic outlook, which are likely to influence the realisation of the stability and convergence programmes (growth, employment, inflation and other important variables);
  • an assessment and a detailed analysis of the budgetary measures and other economic policy measures – taken or envisaged – of relevance in achieving the programme’s aims;
  • an analysis of how changes in the main economic assumptions would affect the budgetary and debt positions;
  • where applicable, the reasons for a deviation from the adjustment path needed to achieve the medium-term budgetary objective.

Stability and convergence programmes must be submitted every year during the month of April. They are published by the Member States.

Examination of the stability and convergence programmes

On the basis of assessments by the Commission and the Economic and Financial Committee, the Council examines the medium-term budgetary objectives presented by Member States in their programmes. It checks in particular:

  • whether the medium-term budgetary objective is based on plausible economic assumptions;
  • whether the measures taken or envisaged are sufficient to achieve the budgetary objective;
  • whether an assessment of the adjustment path shows that the Member State concerned is seeking to improve its (cyclically adjusted) budgetary balance year-on-year;
  • whether annual growth in government expenditure by the Member State concerned is not too high – i.e. does not exceed a benchmark rate in the medium term.

When making its assessments, the Council must take account of the implementation of major structural reforms, especially pension reforms.

The Council is to examine the programme within three months of its submission. On a recommendation from the Commission and after consulting the Economic and Financial Committee, the Council delivers an opinion on the programme. Where it considers that the objectives and content of a programme should be strengthened, the Council can invite the Member State concerned to adjust it.

Avoiding the occurrence of an excessive deficit: the early warning mechanism

As part of multilateral surveillance, the Council monitors the implementation of stability and convergence programmes on the basis of information provided by the Member States and assessments carried out by the Commission and the Economic and Financial Committee.

Thus, if the Commission identifies a significant divergence from the medium-term budgetary objective or from the adjustment path that should lead to that objective being achieved, it will address recommendations to the Member State concerned to prevent the occurrence of an excessive deficit (early warning mechanism, Article 121(4) of the Treaty on the Functioning of the EU).

Furthermore, recommendations adopted in the Council may be made public.

Context

The stability and growth pact is a set of rules putting in place economic and budgetary surveillance at European level. The objective is to guarantee the economic and financial stability of the EU.

Member States must therefore apply healthy budgetary policies in order to avoid the occurrence of excessive government deficits which might endanger the economic and financial stability of the EU.

In 2011, the stability and growth pact was the subject of extensive reforms. The new measures adopted are an important step in guaranteeing budgetary discipline, promoting the stability of the European economy and preventing another crisis within the Union.

The stability and growth pact now includes six legislative acts which entered into force on 13 December 2011:

  • Regulation (EU) No 1173/2011 on the effective enforcement of budgetary surveillance in the euro area;
  • Regulation (EU) No 1174/2011 on enforcement measures to correct excessive macroeconomic imbalances in the euro area;
  • Regulation (EU) No 1175/2011 amending this Regulation on surveillance procedures for budgetary positions;
  • Regulation (EU) No 1176/2011 on the prevention and correction of macroeconomic imbalances;
  • Regulation (EU) No 1177/2011 amending the procedure on excessive deficits;
  • Directive No 2011/85/EU on requirements for budgetary frameworks of the Member States.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1466/97

1.7.1998

–

OJ L 209 of 2.8.1997
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1055/2005

27.7.2005

–

OJ L 174 of 7.7.2005

Regulation (EU) No 1175/2011

13.12.2011

–

OJ L 306 of 23.11.2011

 

Sufficient resources and assistance

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Sufficient resources and assistance

Outline of the Community (European Union) legislation about Sufficient resources and assistance

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Employment and social policy > Social inclusion and the fight against poverty

Sufficient resources and assistance

Document or Iniciative

Council Recommendation 92/441/EEC of 24 June 1992 on common criteria concerning sufficient resources and social assistance in social protection systems [Published in the Official Journal L 245 of 26.8.1992].

Summary

The Member States of the European Union (EU) must recognise the basic right of persons to sufficient resources and social assistance to live in a manner compatible with human dignity.

This right should be implemented under the framework of the Member States’ strategic national policies on combating social exclusion. It concerns all individuals resident in the territory of the EU who do not have access to sufficient resources individually or within the household in which they live.

The level of sufficient resources should be set according to the specific situation of each person, specifically the size of their household, their specific needs and the cost of living in the Member State concerned.

Access by applicants to this right cannot be subject to time-limits, provided that the eligibility conditions continue to be met. However, Member States may create limits concerning students, persons in full-time employment and persons with the capacity to carry out a vocational activity.

Implementation of this right must be ensured within the frameworks of social security schemes. In addition, Member States must in particular:

  • simplify administrative procedures and legal appeals;
  • provide measures of social support;
  • inform the most vulnerable people of their rights;
  • take measures to encourage employment;
  • adapt taxation, social security rules and the civil obligations of persons.

Related Acts

Report of 25 January 1999 from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions on the implementation of the recommendation 92/441/EEC of 24 June 1992 on common criteria concerning sufficient resources and social assistance in social protection systems [COM(98) 774 final – Not published in the Official Journal].
In order to continue to improve the situation of minimum income beneficiaries, the Commission proposes to:

  • optimise social protection for better coverage of basic needs;
  • greater consistency between the minimum social benefits and social benefits, in particular the maintenance of minimum income by topping up income from work;
  • improve access to employment and training;
  • improve the social and economic integration of the beneficiaries of minimum income.

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

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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.

Support for electricity from renewable energy sources

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Support for electricity from renewable energy sources

Outline of the Community (European Union) legislation about Support for electricity from renewable energy sources

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Energy > Renewable energy

Support for electricity from renewable energy sources

Document or Iniciative

Commission Communication of 7 December 2005 “The support of electricity from renewable energy sources” [COM(2005) 627 final – Official Journal C 49 of 28 February 2006].

Summary

This communication reports on the progress made in achieving the objectives set by the Member States in the field of renewable energies, as stipulated by the previous 2001 Directive. It focuses specifically on public support allocated to assist the market penetration of electricity produced from renewable energy sources (RES-E).

The existing support schemes cover the following:

  • feed-in tariffs exist in most of the Member States. These systems are characterised by a specific price, normally set for a period of around seven years, that must be paid by electricity companies, usually distributors, to domestic producers of green electricity;
  • the green certificate system, currently in force in Sweden, the United Kingdom, Italy, Belgium and Poland. RES-E is sold at the conventional market price. In order to finance the additional cost of producing green electricity, and to ensure that it is generated in sufficient quantities, all consumers are obliged to purchase a certain number of green certificates from RES-E producers according to a fixed percentage (quota) of their total electricity consumption/generation;
  • tendering systems exist in two Member States (Ireland and France). Under this procedure, the State issues a series of invitations to tender for the supply of RES-E, which will be sold at market price. The additional cost is passed on to the final consumer in the form of a special tax;
  • tax incentives used exclusively in Malta and Finland.

To assess the performance of these support schemes, it is necessary to:

  • take into account the substantial differences between the national, regional and agricultural resources of different Member States. The wider the gap between “generation costs” and “support”, the less the cost-efficient the system is;
  • take into account the effectiveness of the different support schemes. Effectiveness refers to the ability of a support scheme to deliver green electricity;
  • compare the profits from an investor perspective and compare effectiveness so as to indicate whether the success of a particular policy results above all from substantial financial incentives or whether there are other aspects that have had a crucial impact on market distribution in the countries in question.

The different forms of renewable energy affected by this support include:

  • wind energy, for which analyses show that support is too low for any take-off in a quarter of the Member States. Another quarter of Member States provide enough support but still obtain mediocre results. Feed-in tariffs are currently the most effective systems for wind energy in Germany, Denmark and Spain;
  • biomass forestry requires the use of straw, which is taken into account in analyses of biomass forestry. Denmark is the main country using this type of biomass. In close to half of all European countries, support for this form of renewable energy is still insufficient to develop this high potential sector;
  • the biogas sector is closely linked to environmental policy for waste treatment. In nearly 70% of cases not enough support is provided for the development of this technology;
  • the other renewable energy sources to benefit from this support are hydroelectricity and photovoltaic solar energy (especially in Germany). There are several other sources of renewable energy (geothermal, wave, tidal, solar thermal, etc) which, although they receive support in some Member States, have not yet been developed on an industrial scale.

Circulation of renewable energy on the internal market

These support schemes for RES-E cannot be separated from the internal electricity market. The compatibility of the different renewable energy support schemes with the development of the internal electricity market is essential in the medium and long term. Support for renewable sources of energy falls under the Community framework for State aid for environmental protection, whereas at the national level, the rules on State aid can influence the type of support scheme.

The Commission stresses that the market is dominated by one or several power companies that are too often vertically integrated. The existence of distribution and transport grid operators should guarantee all generators fair grid access, respecting the rules of competition. That is why the independence of these grid operators is vital to the proper functioning of the support schemes.

Governments must also ensure that consumers are informed of the way in which these support schemes for renewable energies affect consumers.

A distinction needs to be made between the physical trade in electricity and the green value of the electricity. RES-E is subject to the same restrictions as conventional electricity, including the mandatory disclosure system. This system makes it compulsory to inform consumers of the contribution of each energy source to the overall fuel mix.

The support covered by the Community framework for State aid for environmental protection may distort competition. These economic effects may however be justified and compensated for by the beneficial effects for the environment. Since the use of renewable energy sources is a priority for Community policy, the mentioned framework tends to favour support schemes. Some sixty support schemes for RES-E were already approved by the Commission during the period 2001 to 2004.

Towards a harmonisation of the rules?

Harmonisation between potential and actual development of renewable energies varies greatly among the Member States. In the short term, harmonisation seems unlikely. The Commission regards harmonisation of the rules in this sector as being desirable, as any changes to the system in the short term might disrupt some markets.

Achieving the potential benefits of harmonisation presupposes:

  • integration of renewable energies on the internal market, making the RES-E sector more competitive;
  • reduction of the forecast costs for RES-E to achieve its target share for 2010 on the basis of a harmonisation of systems such as green certificates and feed-in tariffs. These forecasts suppose the elimination of market distortions caused by support for conventional energy sources;
  • creation of a system of green certificates at the European level that would be more wide-ranging and therefore more liquid, making it possible to ensure greater price stability on national markets;
  • a common feed-in tariff system for the whole of Europe, bearing in mind the availability of resources at the local level. This could lower the cost of all RES technologies in the different Member States once installations are no longer reserved for only some of them.

Avoiding the potential disadvantages of harmonisation presupposes:

  • the absence of any significant fluctuation in the price of green certificates to avoid increasing investor uncertainty and holding back the development of RES;
  • costs linked to information on these technologies and keeping such costs low;
  • development of competitive technologies only, in the context of green certificates, as this system favours profitability above all else. Investment in other promising technologies would be insufficient.

Consideration must also be given to Member States that are importers of RES-E. There is a risk that they will not wish to pay the bill without also benefiting from the advantages at the local level to which they would have access if the renewable energy were being produced on their territory. In any case, the exporting countries may not wish to keep an excess capacity of RES if the public is opposed to building future RES installations on their territory.

Recommendations concerning administrative barriers and grid access

Such barriers appear when the project developers or investors disagree over the installation of new generation capacities or over grid access. The Commission has launched a public consultation into perceptions of these barriers and recommends that action be taken in relation to the following:

  • the large number of authorities involved (national, regional and local) and the lack of coordination between them leads to uncertainty in connection with investment. Single authorisation services should be set up;
  • it can take several years to obtain the necessary permits and this can completely freeze the development of the market. The Member States must set out clear guidelines and a precise division of responsibilities;
  • the insufficient attention given to RES in spatial planning, which must be improved by encouraging public authorities to anticipate future RES projects through the establishment of advance planning mechanisms. It is also important that the planning and authorisation process complies with European environmental legislation.

Grid access problems play a crucial role in the increase in RES-E generation. The Member States have largely put the necessary legislative provisions in place whereby grid operators guarantee transport and distribution. In the view of the Commission, transparent rules are required in order to meet and share out the necessary cost of investment in the grid, as the absence of such rules is the source of numerous difficulties.

Denmark, Finland, Germany and the Netherlands have established rules of good practice in relation to the sharing of the cost of the various investments that have to be made in the grid. Such good practice makes it possible to implement the “shallow” cost approach, under which grid connection costs are borne by project developments or shared with grid operators. These rules should be completely transparent and non-discriminatory.

The Commission stresses the necessity of developing grid infrastructure so as to be able to absorb the future increase in RES-E generation.

Lastly, the Commission recommends the establishment of a system to guarantee the origin of electricity generated from renewable energy sources in order to facilitate trade and ensure transparency for consumers.

Preference for a coordinated approach

In the view of the Commission, harmonisation is still at an experimental stage and it consequently advocates a coordinated approach to support schemes benefiting renewable energy sources, based on the following:

  • international cooperation which would certainly contribute to the development of the different support schemes in Europe, prior to undertaking partial harmonisation;
  • optimisation of national schemes that are indicative of the ineffectiveness of such systems, resulting in a rise in prices for consumers.

In order to optimise their national schemes, the Member States should take the following action:

  • consolidate the legislative framework and limit investment risks linked to the intermittent nature of national support schemes. The system must appear stable and financially viable in the long term in the eyes of economic operators in order to contribute to greater transparency in market prices;
  • encourage technological diversity even if RES technology appears to be the most competitive at present. Better use should be made of exemptions and tax reductions offered to renewable energy sources;
  • ensure compatibility with the internal electricity market with a view to integrating these support schemes in a liberalised energy market;
  • encourage employment and local and regional benefits;
  • work in unison with national energy efficiency and demand management schemes so as to avoid cancelling out the progress achieved by RES-E with an excessive increase in consumption.

Background

The Commission will closely monitor developments concerning European renewable energy policy. It will draw up a report by the end of 2007 at the latest on the levels envisaged by the national systems for promoting electricity from renewable energy sources. It will report on the drive towards the completion of the internal electricity market and further analyse the options for and the impact of possible harmonisation.

Related Acts

of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market [OJ L 283 of 27.10.2001]

 

Supplementary protection certificate for medicinal products

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Supplementary protection certificate for medicinal products

Outline of the Community (European Union) legislation about Supplementary protection certificate for medicinal products

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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

Supplementary protection certificate for medicinal products

Document or Iniciative

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (Text with EEA relevance).

Summary

The purpose of the supplementary protection certificate for medicinal products is to remedy the disparities and shortcomings in national patenting systems for pharmaceutical research. It aims in particular to guarantee sufficient protection for the development of medicinal products in the European Union (EU).

Indeed, the period between the filing of a patent application for a new medicinal product * and authorisation to place it on the market constitutes one of the factors which actually reduces the effective protection afforded by the patent and can compromise the amortisation of investment in research. The lack of sufficient protection can also lead research centres based in the Member States to relocate to countries offering better protection.

In order to also guarantee the free movement of medicinal products, the supplementary certificate for the protection of medicinal products also aims to prevent the development of too many disparities in national legislation.

The certificate is issued if the product for which it was requested, as a medicinal product and at the time when the application was filed in a Member State, meets the following conditions:

  • the product * is protected by a basic patent * in force;
  • the product, as a medicinal product, has been granted a marketing authorisation;
  • the product has not already been the subject of a certificate;
  • the marketing authorisation is the first authorisation to place the product on the market as a medicinal product.

Furthermore, the certificate applies to the product in the same way as the patent from which it benefits. The Regulation also specifies the arrangements relating to application for and granting of the certificate and likewise the conditions for lapse, invalidity and publicity of the certificate.

The certificate cannot be granted for a period exceeding five years. Furthermore, the duration of protection afforded by a patent and by the certificate cannot exceed 15 years overall for the holder’s first marketing authorisation.

This Regulation codifies and repeals Regulation (EEC) No 1768/92.

Key terms in the Act
  • Medicinal product: any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or animals.
  • Product: the active ingredient or combination of active ingredients of a medicinal product.
  • Basic patent: a patent which protects a product, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EEC) No 469/2009

6.7.2009

–

OJ L152 of 16.6.2009

Supplementary protection certificate for plant protection products

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Supplementary protection certificate for plant protection products

Outline of the Community (European Union) legislation about Supplementary protection certificate for plant protection products

Topics

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

Food safety > Plant health checks

Supplementary protection certificate for plant protection products

Document or Iniciative

Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products *

Summary

The Regulation defines the characteristics of the supplementary protection certificate * and lays down the conditions for obtaining a certificate.

The certificate is issued for:

  • any product protected by a basic patent * in force;
  • any plant protection product that has been granted marketing authorisation (this must be the first marketing authorisation) in accordance with Directive 91/414/EEC or an earlier provision of national law;
  • any product that has not already been the subject of a certificate.

The certificate confers the same rights as those conferred by the basic patent and is subject to the same limitations and obligations.

The certificate is granted to the holder of the basic patent or his successor in title.

The application for a certificate must be lodged:

  • within six months of the date on which marketing authorisation was granted for the plant protection product;
  • with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the marketing authorisation was obtained.

The Regulation provides for publication of the fact that the certificate has been granted.

Member States may require that the certificate be subject to the payment of annual fees.

The duration of the certificate may not exceed five years from the date on which it takes effect.

The certificate lapses:

  • on expiry of its period of validity;
  • if the certificate-holder surrenders it;
  • if the annual fee is not paid in time;
  • if the marketing authorisation is withdrawn.

The certificate is invalid if:

  • it was granted contrary to the provisions set out above;
  • the basic patent has lapsed before its lawful term expires;
  • the basic patent is revoked or limited.

Any person may submit an application or bring an action for the certificate to be declared invalid.

Key terms used in the act

Plant protection products: active substances and preparations containing one or more active substances which do one or more of the following:
a) protect plants or plant products against all harmful organisms or prevent the action of such organisms;
b) influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
c) preserve plant products, in so far as such substances or products are not subject to special provisions on preservatives;
d) destroy undesirable plants; or
e) destroy parts of plants, check or prevent undesirable growth of plants.
Active substances: substances or micro-organisms including viruses having general or specific action against harmful organisms or on plants, parts of plants or plant products.
Basic patent: a patent which protects a product, a preparation, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a supplementary protection certificate.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1610/96 8.02.1997 – OJ L 198 of 08.08.1996

 

Sustainable mobility: 2000-2004 action programme

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Sustainable mobility: 2000-2004 action programme

Outline of the Community (European Union) legislation about Sustainable mobility: 2000-2004 action programme

Topics

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

Other

Sustainable mobility: 2000-2004 action programme

1) Objective

To implement a Common transport policy which is safe, efficient, competitive and socially and environmentally friendly.

2) Document or Iniciative

Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions on the common transport policy – “Sustainable mobility: perspectives for the future”
[COM (1998) 716 final – Not published in the Official Journal].

3) Summary

In this Communication, the Commission summarises its priorities in the transport sector for the period up to 2000, based on its Action Programme for 1995 to 2000 and its work programme for 1999. It then sets out its longer-term perspectives for the period 2000-2004.

In recent years some progress has certainly been made on transport, but it is not enough. That is why the strategic objectives set out in the 1995-2000 Action Programme are still valid. Transport in Europe, both in the EU and beyond, must be made more efficient and competitive, and its overall quality has to be improved.

Efficient transport systems will make the sector more competitive and give a boost to growth and employment. To achieve this, we must:

  • Improve market access and functioning, particularly in the rail sector and ports, and eliminate the obstacles which remain in other sectors (in particular civil aviation);
  • Set up integrated transport systems by continuing to develop Trans-European networks and promoting intelligent transport systems such as the Global Navigation by Satellite System (GNSS);
  • Introduce fair and efficient pricing to reduce the distortions of competition between modes of transport and between Member States;
  • Give more attention to the social aspects of transport, including working conditions and working time;
  • Monitor the implementation of Community legislation, particularly on State aids and competition.

To meet the needs of European citizens, emphasis must be placed on the quality of transport services. In the first place, safety must be improved. The Commission will put forward proposals on safety in civil aviation and maritime transport, and will ensure that the action programme on road safety is implemented.

The development of transport services must take account of their possible effects on the environment. So the Commission is giving priority to forms of sustainable transport. In accordance with the guidelines laid down at the Kyoto Conference, it will give particular attention to measures to limit the extent to which transport systems contribute to climate change. It will also tackle the problems of noise and other emissions from aircraft.

Transport policy must also ensure that consumers’ rights are protected. The Commission will therefore give particular attention to civil aviation, where it intends to look at ways of improving consumer information and frequent flyer programmes. It will also focus on improving the quality of local public transport.

Finally, the EU’s fifth Framework Programme for Research and Development will promote the development of safe and sustainable transport systems via research into safety and the ecological characteristics of the different modes of transport.

The common transport policy also has an external dimension. The Commission refers to the negotiations taking place with the central and eastern European countries and to the initiatives taken with Switzerland, the United States, India and China. The increasing globalisation of the economy means the European Union will have to continue developing a coherent policy in its relations with non-EU countries.

In the longer term, the objectives described above must be maintained over the period 2000-2004. The Commission sets out an exhaustive list of the tasks to be accomplished during this period, which include:

  • studying the feasibility of a European Transport Data System;
  • clarifying the regulatory framework, including State aid guidelines;
  • improving the interoperability of transport systems and deploying intelligent transport systems;
  • considering the role of logistics in the transport economy;
  • achieving greater convergence in standards for training and professional qualifications;
  • examining problems and performance in the different modes of transport;
  • finding less environmentally-damaging energy alternatives for transport;
  • putting in place a new regime for Alpine transit;
  • examining the role of international organisations responsible for transport in Europe and the transport implications of UN and WTO reports.

 

Substances affecting the ozone layer

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Substances affecting the ozone layer

Outline of the Community (European Union) legislation about Substances affecting the ozone layer

Topics

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

Environment > Air pollution

Substances affecting the ozone layer

Document or Iniciative

Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer.

Summary

This Regulation replaces Regulation (EC) No 2037/2000. It brings the Community rules into line with technical developments and changes made to the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer. It therefore enables the European Union (EU) to continue its worldwide action to protect the ozone layer and guarantee its recovery.

Scope

This Regulation covers:

  • controlled substances such as chlorofluorocarbons (CFCs), halons, carbon tetrachloride, methyl bromide, hydrochlorofluorocarbons (HCFCs), etc. (see Annex I);
  • new substances (see Annex II);
  • products and equipment containing or relying on such substances.

Prohibitions

The production, placing on the market and use of controlled substances or products and equipment containing these substances shall be prohibited, with the exception of certain uses as feedstock * or process agents *, or laboratory and analytical uses.

The placing on the market and use of fire protection systems and fire extinguishers containing controlled substances, particularly halons, shall be prohibited.

Derogations

Controlled substances may be produced, placed on the market and used as feedstock or as process agents. These substances may also be used for laboratory or analytical uses. The quantity annually authorised shall be restricted by a system of quotas. Producers and importers must have a licence which is granted for a limited period by the competent authority of the Member State concerned.

Hydrochlorofluorocarbons (HCFCs) shall be phased out. No HCFCs may be produced after 31 December 2019.

The use of methyl bromide has been prohibited since 18 March 2010, except in an emergency, to prevent the spread of pests or disease. However, this derogation applies only for a period not exceeding 120 days and a quantity not exceeding 20 tonnes.

Halons may be placed on the market and used for critical uses (see Annex VI).

Any producer or importer authorised to use or place controlled substances on the market may transfer those rights to other producers or importers of such substances within the Community. Any transfer shall be notified in advance to the Commission.

A producer may also be authorised to exceed established levels of production, on condition that the maximum level of national production is not exceeded.

Trade

Imports and exports of controlled substances and of products and equipment containing such substances shall be prohibited.

Nevertheless, derogations exist for certain uses of controlled substances or for their destruction according to appropriate methods.

Imports and exports shall be subject to the issue of a licence. Such licences shall be issued by the Commission using an electronic licensing system.

Control of substances

Undertakings must put in place systems for the recovery of controlled substances contained in:

  • refrigeration, air-conditioning and heat pump equipment;
  • equipment containing solvents;
  • fire protection systems and fire extinguishers.

Once recovered, these substances must be recycled, reclaimed or destroyed in an environmentally acceptable manner in order to prevent their release into the atmosphere.

Undertakings must also take measures to avoid any risk of leakage or release of controlled substances. Any undertaking which operates equipment containing such substances must carry out regular checks for leakage. If leakage is detected, the undertaking must repair it as soon as possible and in any case within 14 days after detection.

Context

The ozone layer protects organisms living on Earth from ultraviolet (UV) radiation. In the 1980s, scientists observed a thinning of the stratospheric ozone layer due to emissions of man-made chemical substances. This depletion of the ozone layer is causing an increase in UV radiation which is dangerous for man, in whom it causes skin cancers in particular, and for ecosystems. The international community took rapid action by first of all adopting the Vienna Convention in 1985 and then the Montreal Protocol in 1987.

The Montreal Protocol requires signatories to phase out ozone-depleting substances according to a pre-established schedule. Twenty years after its adoption, the Montreal Protocol represents a model multilateral environmental agreement.

Key terms of the Act
  • Feedstock: any controlled substance or new substance that undergoes chemical transformation in a process in which it is entirely converted from its original composition and whose emissions are insignificant.
  • Process agents: controlled substances used as chemical process agents in the applications listed in Annex III.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1005/2009

1.1.2010

30.6.2011

OJ L 286 of 31.10.2009

Subsequent amendments and corrections to Regulation (EC) No 1005/2009 have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Commission Decision 2010/209/EU of 26 March 2010 on the allocation of import quotas for controlled substances for the period 1 January to 31 December 2010 under Regulation (EC) No 1005/2009 of the European Parliament and of the Council [Official Journal L 89 of 9.4.2010].