Focu

s

ENPress ServiceDirectorate for the MediaDirector - Spokesperson : Jaume DUCH GUILLOTReference No.: 20100910FCS81938Press switchboard number (32-2) 28 33000 1/24

Strasbourg plenary session

• EU Summit & financial regulation key issues• Medicines, gas security & "trust mark" for e-traders also debated

The recent European Summit and new financial regulation tools were two of the highprofile issues debated by MEPs in Strasbourg for a Parliamentary session. Also on theagenda are steps to improve the monitoring of medicines and proposals to improvethe security of Europe's gas supply should any future gas conflict occur. A European"trust mark" for consumers and trade relations with China are also on the agenda.

You can follow all the news here throughout the week.

Focus

20100910FCS81938 - 2/24

Newsletter - 20-23 September

• Session opens in Strasbourg, eastern France at 1700 CET• Pakistan & China are foreign policy issues ahead

Outcome of EU summit: Van Rompuy in Strasbourg

MEPs will debate the outcome of the EU Summit of 16 September with European CouncilPresident Herman Van Rompuy and the Commission. This is the first time Mr Van Rompuyhas reported back to MEPs in Strasbourg after a meeting of the European Council, as re-quired by the Lisbon Treaty. The main issues will be the EU's relations with its strategicpartners and the state of play of the task force on economic governance chaired by Mr VanRompuy.

Financial supervision: the final vote On Wednesday in Strasbourg

MEPs will be asked to approve a deal with Council on the EU's financial supervision pack-age, which will reshape the financial regulation landscape in Europe. MEPs press for moreflexibility on 2007-2013 budget rules Parliament's Budgets Committee wants the EU to havemore flexible budget rules so that it can respond better to new responsibilities generated bythe Lisbon Treaty such as the new External Action Service or unforeseen events like thecurrent financial crisis.

Joint EU response to future gas supply crises

Gas supply crises in Europe are expected to be better managed and disruption in householdgas supplies avoided, thanks to a new law on better EU-wide co-ordination of supplies andgas interconnection plans.

Independence of air accident inquiries to be reinforced

As air traffic volumes grow, accident prevention measures need to improve too. A new EUlaw to ensure the independence of air accident inquiries will be scrutinised by MEPs inStrasbourg.

Better monitoring of medicines to ensure greater safety

People with medical conditions are set to be better protected and informed about the use andany undesirable side effects of medicines, under an EU law that comes before Parliamentfor approval in Strasbourg.

Controlling pests without risk to public health

Parliament will vote in Strasbourg on safety rules governing pest control products designedto eliminate bacteria in the water supply, slugs in the garden and other pests.

How to fight on-line piracy: make legal content more attractive

The barriers to a digital single market need to be removed, as this would help reduce copy-right infringements on the internet, argues a non-legislative resolution tabled by the LegalAffairs Committee.

Deal with Pakistan on return of illegal immigrants

A new agreement with Pakistan on the readmission by that country of individuals illegallyliving in the EU will be put to a vote by MEPs on Tuesday.

A European "trust mark" for e-traders

The internet is the fastest growing channel for retail sales, yet only one in three consumerswould consider shopping online from another EU country. The Internal Market Committeehas set out proposals to encourage cross-border e-trading and build consumer confidence.

Focus

20100910FCS81938 - 3/24

Debate on EU-China relations ahead of summit

Trade, climate change, the EU arms embargo on China and the situation of human rightsdefenders are among topics likely to be raised in a debate in Strasbourg ahead of the 13thannual EU-China summit of 6 October.

Banning imports made in Chinese labour camps

Parliament will discuss how to stop imports into the EU of products made by prisoners inChinese labour camps. MEPs will also ask the Commission how it intends to raise this issuein talks with China.

Focus

20100910FCS81938 - 4/24

Report & debate to highlight Europe's biodiversity incrisis

• Almost half of Europe's birds and mammals facing extinction• People unaware of scale of crisis says Dutch MEP's report

Almost half of all mammals in Europe are threatening with extinction and the situationis similar with birds. This stark situation is outlined in a report by Dutch MEP ChristianDemocrat Esther de Lange. She quotes the Poet Lucebert (1924-1994) who wrote that "allthings of value are defenceless". The findings will be debated by the European ParliamentMonday just head of a UN conference on biological diversity. It comes in the internationalYear of biodiversity.

The biodiversity loss is projected to accelerate ten-fold by 2050. Across Europe 42% ofmammals, 43% of birds, 45% of butterflies, 30% of amphibians, 45% of reptiles and 52% offreshwater fish are threatened with extinction. An example is the Lynx (pictured) which sawits numbers shrink from an estimated 100,000 in 1900 to barely 150 by 2002. A combinationof urban development, hunting and disease has threatened the Lynx and other creatures.In addition animals such as the lynx in the Iberian Peninsula or the Bavarian pine vole inGermany are now thought to be nearly extinct, and the European mink - once found all overCentral and Eastern Europe - is now one of the most endangered.

People unaware of crisis

According to a Eurobarometer survey in April of this year only 38% of Europeans knew themeaning of the term "biodiversity", while 28% knew the word but not its meaning. In additiononly 17% of respondents believe that they are already touched by biodiversity decline, whichis why an EU-wide information campaign is sorely needed according to Ms Lange's report.

The main EU-level instrument for safeguarding biodiversity and ecosystems is Natura2000, a network of nature protection areas under the Habitats Directive and the Birds Di-rective.

What can be done?

The EU Financial Instrument for the Environment (LIFE) has traditionally played a majorrole in funding biodiversity conservation within the EU, but Ms de Lange believes alterna-tive funding should also be considered, namely through the following policies taking ac-count of biodiversity.

Notably she wants the European Union's Agriculture and Fisheries Policies to be centrestage in the fight to save biodiversity. In addition regional development and research poli-cies (such as the 7th framework programme) can play an important role according to Msde Lange.

You can watch the debate live form the European Parliament in Strasbourg after 18.00 CETMonday 20 September.

Focus

20100910FCS81938 - 5/24

Gas security & supply: Gas firms must ensure suppliesto homes - Vidal-Quadras MEP

• Security & supply key to new energy community• Essential services would be guaranteed if supply disrupted

The disruption of supplies in the "gas war" between Russia and Ukraine in winter 2008 leftmillions of people in 17 European countries shivering in their homes. Now, MEPs will debatea package of new measures that aim to create a gas community in Europe to provide supportbetween countries. In addition they want to define priorities for supply such as hospitals,schools and vulnerable people. We spoke to Spanish MEP Alejo Vidal-Quadras (EPP) whois guiding the regulation through Parliament.

In the case of a gas crisis, your report suggests securing gas supplies to vulnerablehouseholds and essential services like schools & hospitals. How will this be possi-ble?

AVQ: The regulation lays down that Member States should make sure that gas companiesguarantee the supply to protected customers (including homes and essential services) forat least 30 days in the event of a crisis. It is true that some countries, due to their particu-lar situation (e.g. those dependent on a single supplier) would have more difficulties. Thatis why the rules allow supply to be assured by gas reserves in another European Unioncountry. Solidarity is key in this respect.

With respect to priorities, it is clear that the first duty of any public authority is to guaranteesupply to its citizens. Member States would have to identify the priorities in their preven-tive and emergency plans depending on their national situation.

In case of a serious disruption of gas supplies, emergency mechanisms are fore-seen to improve cooperation and solidarity between Member States. Can you ex-plain these?

AVQ: A key point is the obligation, for every Member State, to prepare prevention andemergency plans in consultation with other States and then send them to the EuropeanCommission to get the green light (for the preventive ones), or for consultation (emergen-cy ones). The Parliament has insisted very much on this.

When the Commission receives all the national plans, it will be able to evaluate them froma global perspective, identifying possible inconsistencies between them. So it will be ableto detect any measures incompatible with the internal market or endangering solidarityand ask countries to modify their plans.

More than being about extinguishing the fire, this is about avoiding it. But this does notmean that we can avoid every fire. That is why emergency mechanisms are essential inthe event of a crisis.

Is solidarity between Member States a first step toward a European Energy Commu-nity and joint EU purchase of energy?

AVQ: This regulation is a historical step in European integration, as for the first time Mem-ber States accept that security of supply can only be reached by working together. Thepeople who have been closely following the evolution of European energy policy haveseen the transition from a vision purely based on national interest to a European perspec-tive.

The energy community already exists. The 3 fundamental axes of the common energypolicy - competitiveness, sustainability and security of supply- were established years ago.But as the first two have developed over the years, the third has always been behind, untilthis regulation was approved.

Focus

20100910FCS81938 - 6/24

Nowadays we see the phenomenon of "energy poverty" (people who can't afford toturn on the heating). What can be done to help them to "energy security"?

AVQ: Each day more European citizens suffer the problem of energy poverty. There is nolegal definition of it at a European level, but with the third energy package the EP man-aged to get the problem formally recognised and each Member States has to define it inits national laws.

I think that it is a problem which should be addressed through social policies and nationalgovernments, as well as the EU, should not wait. They should give it as much importanceas to other problems such as housing or marginalisation.

***MEPs will debate the new regulation on Tuesday (21 September) from 0900 CET. You canwatch the debate live online here.

« More than being about extinguishing the fire, this is about avoiding it »

Alejo Vidal-Quadras

Focus

20100910FCS81938 - 7/24

Opening of Strasbourg session: MEPs mourn death offormer President Egon Klepsch

• Tribute to Egon Klepsch (EP President 1992-94)• Resolution on DR Congo postponed

At the opening of this week's session in Strasbourg, MEPs mourned the death last weekendof Egon Klepsch, former President of the European Parliament. "Mr Klepsch devoted most ofhis working life to the unification of Europe", said Parliament's President Jerzy Buzek beforeasking the House to observe a minute's silence. MEPs also voted to postpone Thursday'svote on a resolution on human rights in the Democratic Republic of Congo until the BrusselsOctober session.

Focus

20100910FCS81938 - 8/24

More Europe for safer savings: MEPs give European su-pervisors more powers

• Landmark financial supervision package• Should ensure the stability of the EU's financial system

The financial and ensuing economic crises have exposed European citizens to risks thatwere unimaginable at the time when the economy was booming. Financial institutions havegambled with other people's money, and as a result many have not just lost their jobs, buttheir savings as well. Therefore, the European Parliament has decided, overcoming oppo-sition from some member states, to rein in the markets, giving European supervisors morepowers to police banks and other financial firms.

After difficult, intensive negotiations between the European parliament and the memberstates in the Council of the EU, MEPs will vote on Wednesday (22 September) on a land-mark financial supervision package that is set to change the way European and nationalregulators work to ensure the stability of the EU's financial system. The aim is for it to beput in place with the beginning of 2011.

The crisis: Causes and remedies

Financial markets in the EU are tightly integrated: it's no problem for a bank to havesubsidiaries in more than one EU member; it's no problem to trade in shares and bondsin Frankfurt and London at the same time; it's no problem to invest your savings in fundsout of your country

Currently the supervision of banks and markets largely falls to national supervisors:they focus on banks, markets, funds that have seat in their country; they apply commonrules, but in a manner that's not uniform across EU; they consult, but in a manner that doesnot necessarily lead to common decision how to address cross-border issues.

The crisis has exposed the problem of having a single, European financial marketwithout a European supervisory regime: national supervisors focused on national mar-kets, so European-wide risks were ignored; national regulators had not sufficient insight intorisks of firms that operated Europe-wide and whose failure could trigger financial meltdown

The solution (as first proposed by Larosiere report on the issue from February 2009, thebasis for the Commission's proposals and the final compromise to be voted upon):

It involves plans to establish a European Systemic Risk Board (ESRB) that will focus onEurope-wide risks: e.g. too much cheap money and lax lending standards across the board.

Secondly it will establish three European supervisory authorities (ESAs) that will super-vise banks (European Banking Authority), markets (European Securities and Markets Au-thority), and insurance (European Insurance and Occupational Pensions Authority).

Finally it will ensure that ESAs are at the centre of a tightly bound network of nationalsupervisors to ensure smooth flow of information on risks and consistent implementationof European financial market rules.

Council vs Parliament

There is nothing radically new about this two-pillar structure (ESRB for systemic risk, ESAsfor risks to particular markets). The real question: should European supervisory bodies begiven more powers than they had before the crisis?

The negotiations (from December 2009 Council position to September 2010 trialogue com-promise) saw the EP demanding more powers for European supervisors as the onlyway to ensure the financial supervision system in the EU overcomes its weaknesses. TheCouncil, especially those MS with large financial sectors, wanted to keep European su-pervisors at bay, not interfering unduly with the work of national regulators.

Focus

20100910FCS81938 - 9/24

What EP has achieved in negotiations (i.e. where it substantially revised the Council'sposition, giving European supervisory bodies more powers): Namely it gave powers to ESAsto keep national supervisors in line: investigating breaches of application of EU law, medi-ating in disputes between national supervisors, issuing binding decisions to them. It alsoallowed the ESAs to issue decisions to more financials institutions than Council wanted.

It also entrusted ESAs with scrutinizing financial products and practices and assessing theirimpact on markets, even banning them in extreme cases and put investors and depositorprotection at the heart of the tasks of EBA.

It also allowed EBA to investigate systemically important financial institutions, practices andproducts, design stress tests to evaluate the stability of banks and gave ESMA direct super-vision powers over credit rating agencies.

There is also a review clause: Commission to examine every three years whether furtherresponsibilities are to be given to the ESAs, particularly for direct supervision on institutionswith pan-European reach

The power to declare the existence of a crisis situation will be in the hands of Member Statesalthough the ESRB's will have a number of tools at its disposal to warn about emergingemergencies.

The Parliament's rapporteurs on the dossier were French Liberal Sylvie Goulard for the Eu-ropean Systemic Risk Board (ESRB), British Member Peter Skinner (S&D for the EuropeanInsurance and Occupational Pensions Authority (EIOPA), Spanish MEP Jose-Manuel Gar-cia Margallo Y Marfil (EPP) for the European Banking Authority (EBA) and Sven Giegold(Greens/EFA) for the European Securities and Markets Authority (ESMA).

Focus

20100910FCS81938 - 10/24

New rules for safer medicines

• 5% of deaths from adverse drug reaction• New pharmocovigilence risk assessment committee

Perfectly legal and properly used medicines sometimes have unexpected and serious sideeffects, that are only discovered after the medicine has entered the market and is widelydisseminated. "Pharmacovigilance" - monitoring all drugs on the market to identify previouslyundetected side effects - is therefore vital and Parliament is set to approve an extensiveupdate to EU rules, improving the early detection of rogue side effects to enhance patientsafety.

All new or updated drugs will come with specific warnings for still undetected side-effects,while doctors and patients will be encouraged to report any serious incidents, in a new step inthe ongoing battle to prevent a tragedy like the one with Thalidomide, which caused seriousbirth defects in many babies in the 60s.

Why pharmacovigilance?

Drugs may seem safe and effective in clinical trials, but may reveal side effects when theybecome available to a much wider population.

According to the European Commission 5% of all hospital admissions are due to seri-ous side effects from medicines and many more cases may be unreported. Adverse DrugReaction (ADR) is the fifth most common cause of death, accounting for around 200,000deaths a year, at a cost to society of almost €80 billion.

What is being done?

The aim is to update existing EU rules to improve data collection, treatment and dissemina-tion and better inform the public and doctors. The main changes are:

• All new or updated medicines to be intensely monitored for five years. Doctors andpatients to be informed and encouraged to report all problems.• A new EU "Pharmacovigilance Risk Assessment Advisory Committee" to be createdwithin the EMEA (European Medicines Agency).• Stricter, but simpler rules on monitoring and reporting by drug companies.• A European network of national reporting websites and an EU database, Eudravigi-lance, with all relevant information and guidelines.• Greater transparency through public hearings for ADR related medicines.• Greater coordination in case of emergency and better PILs (Patient InformationLeaflets).

MEPs will debate the new rules on pharmacovigilance Tuesday and vote on them Wednes-day. UK Socialist Linda McAvan is steering the proposals through the EP.

Focus

20100910FCS81938 - 11/24

Security of gas supplies: joint EU response for futuredisruptions

• Households will be protected first during a crisis.• €1.4 billion for infrastructure projects

European households can expect not to have their gas cut off in any future gas supply crisis,thanks to EU-wide co-ordination and interconnection arrangements laid down in legislationapproved by the European Parliament on Tuesday. The legislation also aims to improvethe general management of such crises.

The new rules on the security of gas supply are intended to reduce vulnerability to futuredisruptions and boost infrastructure development at national and EU level. Market mecha-nisms remain the first course of action, but households will be protected first during a crisis.

Within two years Member States will have to design prevention plans and the Commissionwill have an increased role in coordinating emergency measure and ensuring that nationalplans do not endanger the security of supply to other Member States in crisis.

Parliament adopted the draft regulation by 601 votes to 27, with 23 abstentions. Span-ish MEP Alejo Vidal Quadras (EPP) who was responsible for steering the draft legislationthrough the House, emphasised in the final debate on Tuesday morning that the regulationis a "genuinely powerful instrument" to improve security of gas supplies and a "milestoneregarding this issue in the EU" adding that "if applied speedily and effectively it will be apowerful message to our gas suppliers that Europe stands all for one and one for all in thecrises".

Energy Commissioner Günther Oettinger welcomed the end of the legislative process andannounced that the Commission had set aside €1.4 billion for infrastructure projects suchas reverse flows. Implementation of the rules will be reviewed in the next 2 to 3 years.

Household heating guaranteed

In the event of extremely low temperatures European gas companies would be required toensure supplies to householders in the following cases:- extreme temperatures during a seven-day peak period;- any period of at least 30 days of exceptionally high demand;- at least 30 days in the event of infrastructure disruption under average winter conditions.

Preventive measures

Member States will need to ensure that even if their biggest source of gas or a large part ofthe network fails, the remaining network is capable of meeting total daily gas demand on aday of "exceptionally high demand" (which, statistically, happens once every 20 years).

National authorities will have four years to comply with this supply standard but cross-bor-der interconnections among EU countries will have to be in place within three years of thelegislation's entry into force.

Emergency response

If, despite these preventive measures, an emergency happens due to serious disruption orexceptionally high demand, the Member State concerned will activate a national emergencyresponse plan.

The three main crisis levels are "early warning", "alert" and "emergency". In an emergency,the plans must ensure that cross-border access to storage facilities and the flow of gasacross borders are maintained.

Focus

20100910FCS81938 - 12/24

The European Commission would have to declare a "Union emergency" or a regional emer-gency at the request of at least two Member States who have declared national emergen-cies. During a Union emergency, the Commission would ensure a smooth flow of informationas well as coordinating national measures and any joint action with non-EU countries.

Focus

20100910FCS81938 - 13/24

Air accident investigation: Parliament lays down strictcriteria

• Final accident report made public• A European Network of Civil Aviation Safety Investigation Authorities will be set up

A new EU law to ensure the independence of air accident inquiries was approved by theEuropean Parliament on Tuesday. The law also requires airlines to produce a list of thoseon board the plane within two hours of an accident. Before a flight, passengers will be en-titled to name a person to be informed in the event of an accident.

The new EU regulation will ensure that a safety investigation into an accident is conductedfree of pressure from regulatory or other authorities. Any statements taken from individualsby a safety investigator, as well as voice and image recordings inside cockpits and air trafficcontrol units, will be used only for safety investigation, unless there is an overriding reasonfor disclosure to the judiciary. This will ensure that people can testify without fear to thesafety investigators, whose purpose is not to attribute blame but to establish the facts.

As is the case at present, the safety investigation authority will be obliged to make publicthe final accident report "in the shortest possible time and if possible within twelve monthsof the date of the accident or serious incident".

Each Member State must set up a civil aviation accident emergency plan and ensure thatall airlines based on its territory have a plan to assist victims of accidents and their relatives.

Informing victims' families

EU airlines, as well as non-EU airlines departing from an EU airport, will be obliged to pro-duce a list of all those on board an aircraft "as soon as possible, and at the latest withintwo hours of the notification of the occurrence of an accident to the aircraft". Their namescan only be made public after the families or close relatives of the passengers have beeninformed by the authorities and only if they do not object. Furthermore, a list of any dan-gerous goods on board the aircraft will have to be released by the airline immediately afterthe accident.

Airlines will also be required to provide passengers with the means to indicate a contactperson in case of an accident. "This information may be used by the airlines only in theevent of an accident and shall not be communicated to third parties or used for commercialpurposes" says the new law.

European air safety arrangements

A European Network of Civil Aviation Safety Investigation Authorities will be set up to advisethe EU institutions, make Europe-wide air safety recommendations, promote best investi-gation practices and strengthen national safety investigation authorities.

By the end of 2011 the Commission must draft an update of the air safety occurrence re-porting directive. The Cologne-based European Aviation Safety Agency (EASA) will haveaccess to the safety occurrence reports produced by Member States and may be invited toadvise in accident investigations.

This new law, which was approved by MEPs today by 604 votes to 11, with 26 absten-tions, was guided through Parliament by Christine De Veyrac (EPP, FR). It has already beenagreed with the Member States in the Council and will enter into force 20 days after it ispublished.

Focus

20100910FCS81938 - 14/24

European "trust mark" for e-traders

• A European "trust mark" for websites that guarantee reliability• Should be implemented in cooperation with existing trust mark labels

The internet is the fastest growing channel for retail sales, yet only one in three con-sumers would consider shopping online from another EU-country. The European Parlia-ment on Tuesday backed proposals to encourage cross-border e-trading and build con-sumer confidence.

A European "trust mark" for websites that guarantee the reliability and quality of goods soldonline across borders is just one of the non-binding proposals made today by MEPs to boostconsumer confidence and so unlock the growth potential of e-trading for Europe. The newmark, they say, should be based on EU law and be supervised by the Commission. But itshould be implemented in cooperation with existing trust mark labels in Member States andbacked up by standards enforcement mechanisms at national level.

Ending discrimination against cross-border customers

Online sales are often hindered by foreign traders refusing to accept orders from consumersliving in another EU country. MEPs regret that the Services Directive has still not been fullytransposed into the laws of some Member States. They call on the Commission and MemberStates to ensure this is done, thereby putting an end to discrimination against consumerson the basis of their electronic address or residence, and to see that the non-discriminationrule is properly enforced.

Transparency and privacy

MEPs emphasise the need to make e-trading more transparent by ensuring that the con-sumer always knows the identity and contact details of the supplier. They also call on theCommission to strengthen consumers' data privacy, stress the importance of supportingthe most secure technologies for electronic payment systems and call for a European ear-ly-warning system, including a database to combat fraud in the digital market.

Lastly, Parliament calls for a degree of harmonisation of some aspects of consumer contractlaw, especially regarding the handling of certain types of warranty claims.

Next steps

Today's resolution on "completing the internal market for e-commerce" is Parliament's re-sponse to the Commission's March 2010 working paper on barriers holding back consumersand businesses in digital trading.

"E-commerce is a tool with great potential to reshape and improve the competitiveness of theEU economy and the European internal market, and can provide great value and opportu-nities to European citizens and businesses at this time of financial strain", said Parliament'srapporteur Pablo Arias Echeverria (EPP, Spain) ahead of the vote. He added "It is vital thatEuropean Union leaders implement the necessary measures to overcome remaining barri-ers in e-commerce, and create trust and transparency so that both citizens and businessescan fully exploit its benefits".

A new directive on consumers' rights is in the pipeline. In addition, the Commission hascommitted itself to issuing a Code of EU Online Rights by 2012.

Focus

20100910FCS81938 - 15/24

Protecting patients: EU to upgrade medicine safetymonitoring

• MEPs amended the EU pharmacovigilance regulation and medicines code directive• EU and national web portals be set up to give information on medicinal products and

their proven side effects

Patients will be better informed on how to use medicines, and enabled to report their ad-verse effects directly to national authorities, thanks to updates of EU laws agreed with theCouncil and endorsed by Parliament on Wednesday. The EU and Member States will setup pharmacovigilance web sites, and medicines that need special monitoring after beingplaced on the market will be marked with a black symbol.

MEP Linda McAvan (S&D, UK), who steered the draft legislation through Parliament, saidduring the debate that "it is very clear that we need to work together. With a pool of 500 millionpeople, it is much easier and quicker to pick up an adverse reaction than when workingalone at national level".

Pharmaceutical web portals and reporting by patients

MEPs amended the EU pharmacovigilance regulation and medicines code directive to re-quire that EU and national web portals be set up to give information on medicinal productsand their proven side effects. National web portals, to be linked to the EU one, will includeassessment reports, summaries of product characteristics and patient information leaflets.The portals and patient information leaflets will also tell patients how to report any suspectedadverse reactions, using national web portals or other means.

Additional monitoring of new medicines

Some medicinal products (e.g. those with a new active substance) will be authorized subjectto additional monitoring after they are placed on the market. These will be identified by ablack symbol with the statement “This medicinal product is subject to additional monitoring”,together with an explanatory sentence. They will also be listed on the EU web site andnational web portals.

EU single point of receipt for all pharmacovigilance information

The EU "Eudravigilance" database will be the single point of receipt for all pharmacovigi-lance information from marketing authorisation holders and national authorities. It will befully accessible to the Member States, the EU Medicines Agency and the Commission, andalso accessible, "to an appropriate extent", to marketing authorisation holders, health-careprofessionals and the public. Personal data protection will be guaranteed.

Possible review of patient information leaflet and environmental impact

Furthermore, amendments to the EU pharmacovigilance regulation and medicines code di-rective require the European Commission to report back within two years on how to improvethe summary of product characteristics and the package leaflet. If appropriate, the Com-mission may also present proposals to improve the readability, layout and content of thesedocuments.

The Commission is also asked to report back on the environmental effects of medicinal prod-ucts, such as pollution of soil or water by pharmaceutical residues, and to assess whetheramendments to EU legislation are needed to remedy them.

The regulation was approved with 559 votes in favour, 7 against and 12 abstentions.

The directive was approved with 569 votes in favour, 8 against and 15 abstentions.

Next steps

Focus

20100910FCS81938 - 16/24

The new EU pharmacovigilance legislation must be put into effect within 18 months of itspublication in the EU Official Journal.

Focus

20100910FCS81938 - 17/24

EU budget: MEPs want more flexibility and policy de-bate

• MEPs want new Lisbon areas like external action & climate change taken account of• Call on Commission and EU governments to come up with budget review

Parliament wants more flexibility within the EU budget to meet current and future needs.In a resolution passed on Wednesday, it urges the Council to enter into policy negotiationson its budget proposal for 2007-2013. The current (March 2010) proposal is deemed toorigid to provide sufficient funding to meet new challenges, including those arising out of theLisbon Treaty.

The Multiannual Financial Framework (MFF) sets annual ceilings for commitments and pay-ments by category of expenditure. It had to be revised to bring it into line with the LisbonTreaty, but a draft interim report by German MEP Reimer Böge (EPP, DE), approved today,criticises the Council proposal as "purely technical", and "insufficient for Parliament to giveits consent."

"The Council proposal does not add the resources necessary to deliver initiatives that werenot foreseen when the current MFF was adopted in 2006. The most obvious ones are thenew priorities included in the Lisbon Treaty, like the external action service, climate change,energy, civil protection, sports and space. But even before the addition of these new priori-ties, the annual budgets could only be agreed by exhausting the existing margins", said MrBöge, adding that "for the coming years, the remaining margins under the ceilings of theframework are estimated to be negligible."

To meet current and future needs, Parliament would like to see wider margins and reservesbuilt into the framework. This means more flexibility to make changes within and betweenbudget headings.

Parliament also calls on the Council and the Commission to consider rejigging the budgetby establishing "positive" and "negative" priorities, bearing in mind the EU's added value.Commission and Council should finally come up with the long-awaited mid-term review (duein 2009), of all the aspects of EU spending and resources, so that a real policy debate canbe held on future priorities.

The Böge report was approved with 445 votes in favour, 39 against and 18 abstentions.

Focus

20100910FCS81938 - 18/24

Parliament gives green light to new financial supervi-sion architecture

• Three European supervisory authorities (ESAs) will be established• MEPs successfully pushed for consumer protection to be at the very heart of the ESAs'

work

Having fought for more than a year in favour of a radical reform of European financial su-pervision, the European Parliament on Wednesday gave the final seal of approval to apackage of reforms which will see a fundamental shift in the way banks, stock marketsand insurance companies are policed as of 2011.

Three European supervisory authorities (ESAs) will be established to replace the currentsupervisory committees. Their powers will stretch much further than the advisory natureof the current system and their potential to gain further competences will be considerablethanks to a strong review clause. A European Systemic Risk Board (ESRB) will also beestablished with the task of monitoring and warning about the general build-up of risk in theEU economy.

This new system should be able to provide better protection from events such as the Fortisbank crisis weekend, Germany's unilateral naked short-selling ban and the losses faced bylife insurance policyholders in the UK, Ireland and Germany with the collapse of EquitableLife. It should at the same time strengthen the EU single market for financial services andprovide much better investor protection.

Cosmetic or root and branch reform

A number of Member States, particularly those with large financial centres, favoured thelimited reform approach. This led to a significant reduction in the scope of the Commissionproposals, themselves considered by the EP as not going far enough. Parliament's rappor-teurs from the beginning argued that the system needed serious reform so that risk wouldbe better understood, primarily through much improved communication between nationalsupervisors.

The final deal sees the transformation of advisory committees into watchdogs with a bite.The ESAs are set to get tough new powers to settle disputes among national financial su-pervisors and to impose temporary bans on risky financial products and activities. If nationalsupervisors fail to act, then the authorities may also impose decisions directly on financialinstitutions, such as banks, so as to remedy breaches of EU law. The daily work of the ESAswill see them drive coordination within the current system of colleges of national supervisorsset up to watch over cross-border financial institutions.

ESA firefighting powers

In the event of disagreements between national supervisors, ESAs will be able to imposelegally-binding mediation and, if no agreement can be reached within the relevant collegeof supervisors, to impose supervisory decisions on the financial institution concerned ESAswill be able to intervene as mediators at their own discretion, rather than only at the requestof one of the national supervisors.

The ESAs will be able to monitor how national supervisors implement their obligations underEU law. If these obligations are implemented incorrectly, the ESAs may issue instructions tothe national supervisor concerned and, if these go unheeded, directly instruct the financialinstitution to remedy any breach of EU law.

Consumer protection a central goal

In response to the ever more complex world of financial services, MEPs successfully pushedfor consumer protection to be at the very heart of the ESAs' work. ESAs will have thepower to investigate specific types of financial institution, or financial products such as "toxic"

Focus

20100910FCS81938 - 19/24

products, or financial activities such as naked short selling, to assess what risks they pose toa financial market and issue warnings where necessary. Where specific financial legislationso provides, ESAs may temporarily prohibit or restrict harmful financial activities or productsand may also ask the Commission to introduce legislative acts to prohibit such activities orproducts permanently.

ESRB: faster and better warning about risk

MEPs inserted provisions to enable the ESRB to communicate rapidly and clearly. TheESRB will develop a common set of indicators to permit uniform ratings of the riskiness ofspecific cross-border financial institutions and make it easier to identify the types of risksthey carry. The ESRB will also be responsible for establishing colour-coded grades to reflectdifferent risk levels. When making warnings or recommendations on risk build-up, the ESRBis to use the colour-grade to indicate the level of risk.

To enhance the ESRB's ability to predict risk build-up, a broader range of skills and experi-ence, including academics, will be represented on its Advisory Scientific Committee. Finally,to improve visibility and credibility from the outset, the ECB President will preside over theESRB for the first five years.

Powers that may grow

Both the ESAs and the ESRB will be able to grow as events require. Particularly for theESAs, MEPs ensured that the Commission will report back every three years on whether itis desirable to combine the separate supervision of banking, securities, and insurance onthe benefits of having all the ESAs headquartered in one city and on whether the ESAsshould be entrusted with further supervisory powers, notably over financial institutions withpan-European reach.

Role of the European Parliament

MEPs also succeeded in improving democratic oversight of the whole supervisory system. The EP will be able to veto the appointment of ESA chairpersons and will have a say inthe development of the technical standards and implementing measures. Moreover, theESRB President will keep the chair and vice-chairs of the EP's Economic Affairs Committeeupdated on ESRB activities through confidential discussions.

The legislative texts empower the Commission, the ESAs and the ESRB to ask the Councilto declare an emergency. But the Parliament will also be able to ask the Council to declarean emergency through resolutions and questions, in the same way as it has a right to makerequests to the Council and the Commission in any other matter.

Focus

20100910FCS81938 - 20/24

MEPs urge to dismantle remaining barriers in EU-Turkey trade

• Remove barriers to full customs union say MEPs• Parliament also welcomes outcome of referendum on constitutional reform

The EU is Turkey's largest trading partner - a Customs union established in 1996 brought thetwo markets together, but unnecessary barriers still prevent them from using its full potentialsay MEPs. In a resolution they also urged Turkey to stop discrimination against foreignfirms in public procurement, fight counterfeiting and open its airports and harbours to all EUMembers, including Cyprus.

A recent Constitutional referendum in Turkey passed reform measures to the political andjudicial organisation of the country.

Non-legislative resolution based on report drafted by Bulgarian Liberal Metin Kazak wasapproved on 21 of September. The Parliament also welcomed the outcome of referendumon constitutional reform and underlines the importance of the Nabucco gas pipeline projectof EU energy security.

Removing trade barriers on both sides

In the resolution MEPs called for steps to reduce certification and inspections, ("burdensomeimport procedures") and remaining import licences.

MEPs also noted Ankara's failure to implement the additional protocol to the EC-Turkey As-sociation Agreement - (which guarantees access to Turkish airports and harbours for all EUmember states, including Cyprus) and noted that this may "seriously affect" the negotiatingprocess for EU accession, say MEPs.

The resolution also noted that visa restrictions for Turkish businessmen and lorry driversimpede their movement into the EU and that if they are reduced then it could boost trade.

Mr Kazak told us that "custom Union so far reflects the deepest economic integrationreached with any candidate country and can be determined as a success story for the EU-Turkey relations".

He called for mutual political will to eliminate outstanding issues in the functioning of Cus-toms Union and he expects constitutional change to boost democratisation, modernisationand reform process in the country with young and dynamic population.

Turkey• 17th largest economy in the world, sixth largest in Europe• EU candidate country• EU's 7th largest trading partner, 88% of FDI to Turkey comes from the EU

Focus

20100910FCS81938 - 21/24

Safer pest control products

• update EU rules that govern products ranging from insect repellents to water treatmentchemicals

• Agricultural pesticides are covered by separate legislation

"Biocides" to control pests and germs are set to become safer and more environmental-ly-friendly thanks to EU legislation, on which Parliament voted at first reading on Wednes-day. New biocides will also be authorised more swiftly for EU-wide sale than at present.

Parliament's report on the legislation was drafted by German MEP Christa Klass (EPP) andapproved in plenary today with 550 votes in favour, 22 against and 80 abstentions.

Ms Klass commented: "We need biocides to maintain high hygiene standards and preventdisease. I am confident that this legislation will ensure we can reap the benefits of theseproducts, while protecting against the dangers."

The broad aim of the draft regulation is to update EU rules that govern products rangingfrom insect repellents to water treatment chemicals. (Agricultural pesticides are covered byseparate legislation.) For the first time, materials treated with biocides will also be regulated.

Parliament adopted a number of amendments to the draft legislation that will now have tobe considered by the Council of Ministers.

New EU-level approvals for pest control products will streamline the application process forcompanies, but Parliament believes this approach should be phased in gradually.

Banning the most toxic chemicals

Parliament voted to ban the most toxic chemicals - especially those that are carcinogenic,harmful to fertility or interfere with genes or hormones. It also tightened up requirements togradually replace other hazardous substances with less harmful alternatives.

Exceptions in exceptional cases

Regrettably, even highly toxic substances may at times be needed to protect human health,other animals or the environment - for example to control rodents in the absence of effectivealternatives. MEPs had considered recommending new restrictions on the commonly-usedrat poison 'difenacoum', but a narrow majority rejected this proposal.

EU authorisation

MEPs want a centralised, EU-level approval of biocides to be phased in gradually. The Eu-ropean Chemicals Agency, they say, should be tasked with assessing applications for newand "low-risk" products from 2013 and most other biocides from 2017. But Member Statesshould continue to decide on products that potentially pose the biggest health risks andshould also retain the right to impose extra controls on the use of products approved at EUlevel.

Minimising animal testing

Parliament also decided that, as in EU "REACH" rules for chemicals, companies shouldbe obliged to share data from the tests they conduct on animals (in return for reasonablecompensation) in order to prevent duplication of experiments.

Special attention to nanomaterials

Lastly, with doubts remaining over the possible long-term health effects of nanomaterials,MEPs insisted on the need for separate assessment of such particles in biocidal products.

Focus

20100910FCS81938 - 22/24

Van Rompuy reports to MEPs on European summit

• Foreign affairs dominated Summit• Task Force on economic governance report in October

Foreign affairs, economic governance and the situation of Roma people in Europe werethe main issues raised in Wednesday's debate on the outcome of the EU Summit of 16September. It was the first time President of the Council Herman Van Rompuy has reportedback to MEPs in Strasbourg after a meeting of the European Council.

He said the main focus of the Council was external relations and the preparation of upcominginternational summits and on the relations with strategic partners.

Referring to the Task Force on economic governance which he heads, he said it had madeprogress on the development of a new macro-surveillance framework, and the strengtheningof national fiscal frameworks. He said it will produce its final report for the October Councilwith the Commission due to present legislation proposals at the end of September.

Speaking of the Roma and the controversy over their expulsion from France, Mr VanRompuy said that the key message is that a Member State has the right to uphold the ruleof law within their territory, while the Commission has the right and the duty to conduct in-vestigations to ensure application of European law.

Joseph Daul, leader of the Parliament's largest group - the centre right European People'sParty (EPP), said he respected the Commission’s right to check that European law is imple-mented correctly, but regretted the language used during the discussions on the Roma. Heunderlined the importance and duty of member states to try to integrate minorities and theminorities' duty to show the will to be integrated. On foreign policy he said "the only way toachieve respect and understanding around the world was through a coordinated and strongforeign policy".

Socialist Martin Schulz said that when we talk about international diplomacy and interna-tional trade, it can work only if it fits in with the domestic policies back home. That is whatis going on in EU at the moment.

He said the Parliament is calling for the community method in terms of resolving problems.He said his group wanted it to be done at EU level in a community way and that the task ofEP is to get the community method through. Regarding Roma, he called for it to be resolvedand called human dignity an inviolable issue. He also stressed that European law has to beaccepted and enforced by Member States.

The Liberal leader Guy Verhofstadt said the Commission has acted in the right way re-garding the Roma and that values are as important as market rules. He went on to stressthat it is important that everybody sees that the EC is treating every State equally, no matterhow big or small.

"On economic governance we have no time to waste" he said. "We need, as fast as possible,a package on the table". He went on to say that "to be credible, the package needs tofulfil some conditions", such as "effective sanctions -progressive, combining political andeconomic, voting rights suspended of those breaking the rules".

Rebecca Harms of the Greens said that "we're living in completely different galaxies". ThePresident of the European Council and the Task Force should have the responsibility to"move the EU out of the crisis". she was satisfied that the Commission will make proposalson economic governance, but "it shouldn't focus only on sanctions".On the Roma she regretted the missed opportunity for the Council to support action againstFrance and worried that "populist leaders in Europe focus on "domestic problems with xeno-phobic policies, and fomenting insecurity".

Focus

20100910FCS81938 - 23/24

Timothy Kirkhope for the European Conservatives and Reformists said that theCommission's recent attack on France was not really helpful for European unity. He urgedall actors to parts to be constructive with their input in the Roma discussion. He also wel-comed the EU´s assistance to Pakistan and underlined that the only way to ensure longterm development in Pakistan is through trade and economic ties.

Patrick Le Hyaric for the leftist GUE/NGL group attacked the conclusions of EuropeanCouncil and asked for concrete and specific actions to be taken in the case of the Romaand in combating poverty, unemployment, famine and climate change.

Niki Tzavela of the Europe of Freedom and Democracy group mentioned China sayingit has reserves amounting to 2.4 trillion US dollars, and is looking to invest in Europe. Sheasked if in the upcoming Council Summit would discuss setting aside the obstacles whichthe EU has in terms of its relations with China, in particular on human rights and Iran.

Focus

20100910FCS81938 - 24/24

End impunity in DRC

• Country ravaged by poverty & war• Culture of impunity persists

The culture of impunity, atrocities and violence against civilians and the plundering of naturalresources in the Democratic Republic of Congo must come to an end, MEPs said in a debateon Wednesday, 22 September. Parliament held discussions in light of a recent UN draftreport (to be made public on 1 October) that documents the worst human rights violationsin the Democratic Republic of the Congo (DRC) between 1993 and 2003.

Africa's "World war" 1998-2003: over 5,4 million dead in the conflict. Violence continues inEastern DRC.

Rape has become a weapon of war used by rebels, members of the Congolese army andcivilian. The UN estimates that over 200,000 women have been raped since war began inthe DRC more than a decade ago. Despite its wealth of natural resources including mineralsand forests, DRC is one of the poorest countries in the world – 80 % of its population live inpoverty and it is struggling to recover from years of conflict.

In the debate MEPs highlighted that perpetrators go free and called for an end to the im-punity. Several MEPs also mentioned the role and passive nature of UN troops.

Belgian Socialist MEP Veronique De Keyser warned that a culture of immunity still remainsdespite the efforts of the international community.

Filip Kaczmarek (EPP), a Polish MEP, cited the French charity MSF saying that "55 % of allrapes committed in the world have been committed in Eastern Congo". He said the problemon such a scale that UN is doing very little to put an end. "This culture of impunity must befinished once and for all!" Green MEP Isabelle Durant also stressed that the pillage of theDRC was continuing with impunity.

Speaking for the Council and representing EU foreign Affairs Chief Catherine Ashton OlivierChastel noted that impunity for those who commit crimes was a major problem.-

Charles Goerens (ALDE) said that any response must come from the African Union, the UNand the International Community.

Marie-Christine Vergiat (GUE/NGL) noted that it took the gang rape of scores of people thissummer to force the international community to act.

Charles Tannock (ECR) told the House that "the Kimberley Process to be extended to cov-er other key natural resources in Africa. Human rights abuses in Africa, which are all toocommon regrettably, are often linked to competition for the control of mineral resources. TheKimberley Process has been hugely successful in curtailing the trade in conflict or blooddiamonds".

Dutch MEP Bastiaan Belder (EFD) said "the crimes are taking place exactly where we findCongo's biggest economic richness. Following recent sources, the economic potential ofmines in that country is 24 billion."