Henvendelse fra Forbrugerrådet om tjenesteydelser, forbrugerbeskyttelse

Europaudvalget Folketinget Christiansborg 1240 København K
	Villy Dyhr Dok.20634/ph
	24. november 2003

Møde i Europaudvalget 28. november 2003

På Europaudvalgets møde fredag den 28. november 2003 kl. 11 behandles bl.a. Rådsmøde (beskæftigelse, socialpolitik, sundhed og forbrugerbeskyttelse) den 1.-2. december 2003.

Forbrugerrådet har følgende kommentarer til udvalgte punkter på dagsordenen:

Pkt. 9. Udkast til Rådskonklusioner om sikkerheden ved tjenesteydelser for forbrugere KOM (2003) 0313 - vedtagelse

Forbrugerrådet er ikke enig i Rådsresolutionen om forbrugernes sikkerhed i forbindelse med udbud af tjenesteydelser.

Rådsresolutionen lægger alene op til en forbedring af videnbasen om sikkerhed af tjenester, bl.a. via dataindsamling og udveksling af informationer medlemsstaterne imellem. Det er efter Forbrugerrådets opfattelse ikke tilstrækkeligt ambitiøst. Forbrugerrådet ønsker, at Kommissionen fremlægger et forslag til en rammelovgivning på området. Dette udelukker ikke, at der kan udarbejdes sektorspecifik lovgivning på prioriterede områder.

Kommissionen har peget på turisme, sport og fritid som prioriterede områder, hvilket Forbrugerrådet kan tilslutte sig. Dog finder vi, at tjenester inden for sundhedsområdet også bør være et højt prioriteret område.

./. Høringssvar af 25. september 2002, 11. september 2003 og 20. november 2003 vedlægges.

Pkt. 10. Forslag til Europa-Parlamentets og Rådets forordning om samarbejde mellem nationale myndigheder med ansvar for håndhævelsen af lovgivning om forbrugerbeskyttelse KOM (2003) 0443, Retsgrundlag TEF art. 95 - politisk debat

Forbrugerrådet hilser udkastet til forordning velkommen, da

• de nationale myndigheder får effektive og konkrete handlingsmuligheder, når det drejer sig om krænkelser over grænserne.

• det åbner mulighed for, at det nye direktivudkast vedrørende urimelige forretningsmetoder bliver effektivt.

Forslaget kan dog skabe problemer for de ny medlemslande, der ikke har offentlige myndigheder med de beskrevne håndhævelsesmuligheder.

./. Høringssvar til Forbrugerstyrelsen af 22. september 2003 vedlægges.

Pkt. 13. Forslag til Europa-Parlamentets og Rådets forordning om oprettelse af et europæisk center for forebyggelse af og kontrol med sygdomme KOM (2003) 0441 - politisk enighed

Overordnet set virker det hensigtsmæssigt at etablere et europæisk center for forebyggelse af og kontrol med sygdom. Forbrugerrådet har ikke været på høringslisten i forhold til forslaget og har derfor ikke forholdt os til detaljerne i forslaget. Især erfaringerne omkring SARS viste, at det var både hensigtsmæssigt og effektivt med det internationale samarbejde omkring sygdommen

Pkt. 16. Rådskonklusioner vedrørende medicinsk udstyr - vedtagelse

Forbrugerrådet kan kun støtte den positive målsætning om at skabe større gennemsigtighed og tillid til markedsføringen af medicinsk udstyr, der ligger i rådskonklusionerne. En måde at opnå dette på kunne være, at der åbnes mulighed for indberetning af hændelser og ulykker for patienter og forbrugere direkte til relevant myndighed.

Pkt. 17. Rådsresolution om lægemidler og folkesundhedsmæssige udfordringer - fokusering på patienterne - vedtagelse

Forbrugerrådet har sammen med andre europæiske forbrugerorganisationer overordnet forholdt sig positivt til Kommissionens svar på G10-rapporten. I et fælles høringssvar er der dog lagt vægt på, at ændringsforslag på lægemiddelområdet klart skal kunne vises at være til fordel for forbrugeren og ikke kun for industri eller det offentlige. Forbrugerrådet er også enig i behovet for at forbedre kvaliteten af og adgangen til information om lægemidler for patienter samt for at styrke overvågningen på lægemiddelområdet med henblik på sikkerheden. Med hensyn til information til patienter og forbrugere vil forbrugerorganisationerne fortsat advare mod at reklamere for receptpligtig medicin, men også mod metoder til at omgå et forbud, f.eks. gennem oplysning om sygdom eller undervisningskampagner sponsoreret af industrien. I relation til overvågning af lægemiddelområdet skal vigtigheden af at forbedre bivirkningsindberetning nævnes, og der bør etableres mulighed for, at forbrugerne kan indberette bivirkninger direkte til relevant myndighed.

./. Den europæiske forbrugerorganisation BEUC's høringssvar vedlægges.

Med venlig hilsen

 

 

Rasmus Kjeldahl  Villy Dyhr

Direktør Chef for Politisk Afdeling

Forbrugerstyrelsen Amagerfælledvej 56 2300 København S Att.: Henrik Bruun Johannessen
	Helen Amundsen Dok. FBR Lib:8632.1/ph
	25. september 2002

Høring over Kommissionens diskussionsoplæg vedrørende "Safety of Services for Consumers"

Forbrugerrådet har modtaget skrivelse af 29. august 2002, sag 1352/1-149, om Kommissionens diskussionsoplæg vedrørende "Safety of Services for Consumers".

Forbrugerstyrelsen har bedt om kommentarer til følgende punkter:

1. Identificering af tjenesteydelser, hvor der kan være behov for fællesskabsregulering

Kommentar: Det er Forbrugerrådets opfattelse, at der inden for de tjenesteområder, hvor der kan være en sikkerheds- og sundhedsmæssig konsekvens for forbrugeren, er brug for fællesskabsregulering uafhængigt af området. Det kan dog på grund af områdets kompleksitet være relevant at udvælge et eller flere områder som pilotprojekt, hvorefter det vil være muligt at vurdere, om andre tjenesteområder vil være dækket forsvarligt.

Kommissionen har valgt i dette diskussionsoplæg ikke at koncentrere sig om tjenester, der kan have en økonomisk konsekvens, transporttjenester, offentlige tjenester som politi, civil beskyttelse og hæren, tjenester rettet mod professionelle samt ansvar i forbindelse med udbydere af tjenester. Forbrugerrådet finder det dog også vigtigt, at tjenester som finansielle ydelser og teletjenester, der kan have en økonomisk konsekvens for forbrugeren, omfattes af fællesskabsregulering, men at det er fornuftigt at adskille de to områder. Det er derimod ikke acceptabelt at udelade ansvar i forbindelse med tjenester, der kan have en sikkerheds- og sundhedsmæssig konsekvens for forbrugeren. Det er muligt, at det for overskuelighedens skyld er fornuftigt som første step at koncentrere sig om sikkerheden og sundheden, men andet step bør være fællesskabsregulering af ansvar i forbindelse med levering af tjenester i tråd med produktansvarsloven.

2. Om følgende initiativer kan bidrage til at øge forbrugerbeskyttelsen

• tilvejebringelse af statistiske oplysninger vedr. uheld i forbindelse med tjenesteydelser

Kommentar: Der er ingen tvivl om, at statistiske oplysninger om ulykker i forbindelse med tjenester vil være en hjælp til udformning af fællesskabsregulering, ligesom ulykkesregistreringssystemet EHLASS i høj grad er blevet anvendt i forbindelse med udarbejdelse af produktstandarder. Men det er samtidig vigtigt at pointere, at mangel på statistiske oplysninger ikke er noget argument for ikke at udforme fælles regler. Dette er også beskrevet i businessplanen for standardiseringsarbejdet i CEN/TC52 Safety of toys med følgende Note: "The absence of an accident history may not be a good reason for an automatic presumption of a low level of risk. Other factors should be taken into account such as risk assessment, particularly when the possible severity is high. Appropriate data may not be available for many reasons including the absence or ineffectiveness of a data collection system, the time delay in collating and presenting statistics, changes in production design and use conditions etc.".

Ligeledes vil det formodentlig ikke være muligt at etablere et fælles ulykkesregistreringssystem for alle tjenester, da ulykkerne er af meget forskellig karakter, lige fra komplikationer efter operationer i sundhedsvæsnet til dårlig vedligeholdelse af legepladser.

Forbrugerrådet kan tilslutte sig forslaget om, at udbydere af tjenesteydelser skal registrere og rapportere ulykkesdata. Dette eksisterer allerede på områder som forlystelsesparker, hvor der føres logbog over den enkelte forlystelse. Og som det også nævnes i Kommissionens forslag, kan denne udveksling af oplysninger anvendes i forbindelse med risikovurdering og forebyggelse. Forbrugerrådet kan ligeledes tilslutte sig Kommissionens forslag om udarbejdelse af et summary på baggrund af oplysninger fra medlemslandene, der gøres tilgængeligt for offentligheden.

• fremme af "best practice" og standarder for tjenesteydelsers sikkerhed

Kommentar: Det er ikke Forbrugerrådets opfattelse, at "best practice" og frivillige standarder automatisk højner sikkerheden for forbrugeren. Dette vil være helt afhængigt af, hvor mange udbydere der tilslutter sig "best practice", og hvor mange udbydere der benytter sig af de frivillige standarder. Der findes eksempler på, at frivillige aftaler bliver brugt til at forhale en højnelse af sikkerheden for forbrugeren, eksempelvis inden for bilindustrien, hvor man de seneste 10 år har forhandlet om et direktiv for sikkerhed for fodgængere i forbindelse med bilers udformning. Dette er nu endt i en frivillig aftale, hvor forbrugeren er dårlige stillet end i direktivudkastet, og hvor forbedringer af sikkerheden ligger meget langt ude i fremtiden.

Samtidig er det Forbrugerrådets klare opfattelse, at det ikke kan være forbrugerens ansvar og opgave at skulle vurdere sundhed og sikkerhed i forbindelse med tjenester, ligesom det heller ikke er tilfældet for produkter. Som oftest vil det ikke være muligt for forbrugeren at vurdere disse parametre, med mindre man har et indgående kendskab til området. Sundhed og sikkerhed er basiskrav, der bør være opfyldt, når man køber en tjeneste

• frivillige "safety management schemes" og certificering på baggrund af et fælles EU-regelsæt

Kommentar: Effekten af et "safety management scheme", eksempelvis i tråd med ISO 14001-strukturen, vil være helt afhængig af, hvor mange udbydere der tilslutter sig systemet. Ulempen er ligeledes, at der vil være tale om selvdeklarering.

• generelt sikkerhedskrav for tjenesteydelser

Kommentar: Udarbejdelse af et generelt regelsæt for tjenesteydelser i lighed med det generelle produktsikkerhedsdirektiv er efter Forbrugerrådets opfattelse den optimale og eneste rigtige løsning for at sikre, at tjenester ikke har nogen sikkerheds- eller sundhedsmæssig konsekvens for forbrugeren. Regelsættet kan udformes som et rammedirektiv, der dækker alle områder, og rammerne kan udfyldes af standarder, der er bundet op på direktivet. Det er dog vigtigt at vurdere, hvor standarder kan være en hjælp, eller om der er områder, der kræver specifik lovgivning. Der vil formodentlig både være brug for udarbejdelse af horisontale standarder, der dækker tjenesteområder med fællestræk, og standarder, der specifikt er rettet mod den enkelte tjeneste. Som en hjælp til forbrugeren er det fornuftigt at etablere et certificeringssystem, der kræver involvering af en tredjepart, der kan synliggøre over for forbrugeren, at kravene i de relevante standarder er opfyldt. Dette vil være en stor hjælp for forbrugeren, når man skal vælge udbyder.

• forpligtelser for tjenesteydere til at iagttage forebyggende forholdsregler (information, uddannelse m.m.), enten generelt eller for visse sektorer

Kommentar: Forbrugerrådet kan tilslutte sig Kommissionens forslag om at etablere generelle krav til tjenesteudbydere med hensyn til risikohåndtering, information til forbrugerne samt uddannelse af personale.

• tilsyn og markedskontrol

Kommentar: Erfaringen fra det generelle produktsikkerhedsdirektiv viser klart, at der vil være et behov for tilsyn og markedskontrol. På produktområder, hvor der ikke er en effektiv markedskontrol, dukker der produkter op, der ikke er i overensstemmelse med kravene i lovgivningen, og forbrugeren har ingen mulighed for at skelne mellem sikre og usikre produkter. Det samme vil efter al sandsynlighed ske på tjenesteområdet, og heller ikke her vil forbrugeren have mulighed for at vurdere sikkerheden. Selv et certificeringssystem er ikke nogen garanti; det har vist sig på flere produktområder.

1. Forslag til andre initiativer til beskyttelse af forbrugernes sikkerhed i forbindelse med tjenesteydelser

Kommentar: Som nævnt ovenfor finder Forbrugerrådet, at et generelt direktiv, der dækker alle tjenester, er den optimale og rigtige løsning.

Med venlig hilsen

Helen Amundsen

Ingeniør

Forbrugerstyrelsen Amagerfælledvej 56 2300 Købenavn S Att.: Henrik Bruun Johannessen E-mail: hbj@fs.dk
	Helen Amundsen Dok. 18462/ph
	11. september 2003

Høring om safety of services KOM (2003) 313

Forbrugerrådet har modtaget Forbrugerstyrelsens brev af 20. august 2003, sag 100/1-54, om høring vedrørende Kommissionens beretning til Europa-Parlamentet og Rådet om forbrugernes sikkerhed i forbindelse med udbud af tjenester, KOM (2003) 313, og har følgende bemærkninger.

Kommissionen forslår i sin beretning, at der indføres en procedure for udveksling af information om udviklingen i politikker og lovgivning mellem myndighederne i medlemslandene, at der fastlægges bestemmelser for systematisk indsamling og vurdering af data og risici, og at der indføres procedurer for fastlæggelse af europæiske standarder, hvis og når behovet viser sig.

Det er umiddelbart Forbrugerrådets opfattelse, at denne løsningsmodel ikke er tilstrækkeligt ambitiøs for tjenesteydelsers sikkerhed. Forbrugerrådet finder stadig, som nævnt i tidligere høringssvar af 25. september 2002, at et generelt horisontalt regelværk for tjenesteydelsers sikkerhed, suppleret med specifikke regelværk for bestemte områder som sundhedsydelser, fritidsaktiviteter etc., bør indgå i den kommende strategi. Det er også Forbrugerrådets klare overbevisning, at et generelt regelværk bør suppleres med fællesskabsregulering af ansvar i forbindelse med levering af tjenester i tråd med loven om produktansvar. Loven om produktansvar har netop været medvirkende til, at industrien har taget sikkerhed af produkter alvorligt.

Forbrugerrådet er enig i, at der bør etableres et indsamlingssystem for ulykker i forbindelse med tjenester i tråd med EHLASS-systemet, der har været et godt værktøj til brug i standardiseringsarbejdet for produkter.

Forbrugerrådet er ligeledes enig i, at der skal indføres procedurer for fastlæggelse af europæiske standarder, der kan udfylde rammerne i regelværket. Det skal dog sikres, at alle stakeholdere, herunder ngo'er, skal have en reel mulighed for at deltage i og influere på standardiseringsarbejdet, og at der sikres en balanceret repræsentation i arbejdet. Forbrugerrådet er derfor ikke tilhænger af de såkaldte new deliverables, der lanceres i standardiseringsorganisationerne, da disse ikke sikrer en demokratisk proces.

Information er et af nøgleordene i forbindelse med udbud af tjenester, der skal gøre forbrugerne i stand til at sammenligne tjenester. Det er derfor vigtigt at overveje, hvordan det kan sikres, at forbrugerne får den nødvendige information på en forståelig måde. Opgaven kan løses ved hjælp af lovgivning eller standardisering eller begge dele. Der skal stilles krav til, hvordan information skal præsenteres, og hvilken type information der skal indgå som et grundlæggende krav. Forbrugerne har brug for klar information i et forståeligt sprog om alle aspekter i forbindelse med tjenesteydelsen samt om, hvilke betingelser der gælder.

Med venlig hilsen

Villy Dyhr  Helen Amundsen

Chef for Politisk Afdeling  Ingeniør

Forbrugerstyrelsen Amagerfælledvej 56 2300 København K Att. Henrik Bruun Johannessen E-mail: hbj@fs.dk
	Helen Amundsen Dok. 20491/ph
	20. november 2003

Rådsresolution om forbrugernes sikkerhed i forbindelse med udbud af tjenesteydelser

Forbrugerrådet har modtaget notat af 11. november 2003 til EU-specialudvalget vedr. rådsresolution om forbrugernes sikkerhed i forbindelse med udbud af tjenester.

Forbrugerrådet er ikke enig i den fremlagte danske holdning, som det også fremgår af Forbrugerrådets tidligere brev af 11. september 2003. Rådsresolutionen lægger alene op til en forbedring af videnbasen om sikkerhed af tjenester, bl.a. via dataindsamling og udveksling af informationer medlemsstaterne imellem. Det er efter Forbrugerrådets opfattelse ikke tilstrækkeligt ambitiøst. Fremlæggelse af et forslag til en rammelovgivning på området udelukker ikke, at der kan udarbejdes sektorspecifik lovgivning på prioriterede områder.

I den forbindelse har Forbrugerrådet noteret sig, at Kommissionen har peget på turisme, sport og fritid som prioriterede områder, hvilket Forbrugerrådet kan tilslutte sig. Dog finder vi, at tjenester inden for sundhedsområdet også bør være et højt prioriteret område.

I rådsresolutionen peges endvidere på, at Kommissionen skal overveje, hvordan europæiske standarder kan bidrage til, at forbrugerne sikres et højt fælles sikkerhedsniveau for tjenesteydelser. Det er Forbrugerrådets opfattelse, at standarder kan bidrage til et højt sikkerhedsniveau, såfremt de udarbejdes på baggrund af et fornuftigt mandat, der klart angiver, hvilket sikkerhedsniveau der ønskes opnået, og at standarderne er knyttet til en rammelovgivning.

Det er derfor bekymrende, at DG Enterprise har givet CEN, CENELEC og ETSI mandat til at udvikle et arbejdsprogram for standardisering inden for tjenesteområdet, før behandling af DG SANCO's rapport om sikkerhed af tjenester er afsluttet.

Samtidig er det efter Forbrugerrådets opfattelse ikke standardiseringsorganisationernes opgave at prioritere, hvilke tjenesteområder der bør standardiseres. Mandatet er vagt, og det eneste krav, der umiddelbart stilles til prioritering, er - citat: "Priority will be given to those service sectors where intra-community trade is already occuring or is desired. Additionally, priority should also be given to those areas where the stakeholders (e.g. economic, societal) show a keen interest in the benefits of standardisation". Denne formulering sikrer ikke, at turisme, sport og fritid vil være områder, der skal prioriteres, som det fremgår af rapporten om sikkerhed af tjenester.

Afslutningsvis skal Forbrugerrådet også påpege, at det bør sikres, at alle stakeholdere, herunder ngo'er, skal have en reel mulighed for at deltage i og influere på standardiseringsarbejdet, og at der sikres en balanceret repræsentation i arbejdet.

Med venlig hilsen

 

Villy Dyhr  Helen Amundsen

Chef for Politisk Afdeling Ingeniør

Forbrugerstyrelsen Att. Susanne Bo Christensen E-mail: sc@fs.dk
	Benedicte Federspiel Dok. 18718/ph
	22. september 2003

Kommissionens forslag om samarbejde mellem nationale håndhævelsesmyndigheder

Forbrugerstyrelsen har med skrivelse af 19. august 2003, sag 2003-101/1-97, anmodet om en udtalelse vedrørende Kommissionens forslag om samarbejde mellem nationale håndhævelsesmyndigheder med ansvar for håndhævelse af lovgivning om forbrugerbeskyttelse (KOM(2003) 443 endelig udg.).

Forbrugerrådet hilser udkastet til forordning velkommen, idet det er et vigtigt skridt for at fastholde et højt niveau på forbrugerbeskyttelsesområdet. Det vil medføre, at de nationale myndigheder får effektive og konkrete handlingsmuligheder, når det drejer sig om krænkelser over grænserne.

Forbrugerrådet finder ligeledes, at det er en vigtig del af muligheden for, at det nye direktivudkast vedrørende urimelige forretningsmetoder skal blive effektivt.

Forbrugerrådet er imidlertid bekendt med, at det allerede har skabt problemer for flere lande, der ikke har offentlige myndigheder med de håndhævelsesmuligheder, som beskrives i forslaget, herunder ikke blot i de "gamle" EU-lande, men i høj grad i de 10 nye medlemslande.

Forbrugerrådet skal vende tilbage med yderligere kommentarer, så snart høringssvar fra vores europæiske forbrugerorganisation BEUC foreligger.

Med venlig hilsen

 

Villy Dyhr Benedicte Federspiel

Chef for Politisk Afdeling  Chefkonsulent

BEUC BEUC/410/2003

The European Consumers' Organisation 04/09/2003

Bureau Européen des Unions de Consommateurs

Avenue de Tervueren, 36/4

B - 1040 Bruxelles

Tel: (32 2) 743.15.90

Fax: (32 2) 740.28.02

consumers@beuc.org

 

A stronger European based pharmaceutical Industry for the benefit of the patient – A call for action

BEUC draft comments

Summary

The Commission came forward with a communication called: "A Stronger European-based Pharmaceutical Industry for the Benefit of the Patient – A Call for Action" on July 1^st 2003. The Commission Communication is a response to the "G10 medicines" report presented on May 7^th 2002. This BEUC paper comments on the actions suggested by the Commission and add to our previous comments about the G10 group and their work.

In general we welcome the Commission response. We set out our views on a number of the specific recommendations below, especially concerning better information to patients about the possible side-effects from medicine use including the gathering and the of such information.

 

Benefits for all

The way in which the pharmaceutical market operates has significant implications for the welfare of patients and the wider public. Access to drug treatments that are affordable, appropriate, safe and effective is an essential component of a good health care system. BEUC supports the need to ensure that the EU pharmaceutical market is competitive and innovative - and works in the interests of consumers. However it is essential that where there are proposals for changes to this market that there is strong evidence to show that consumers - and not just industry or government - will benefit from these changes and will certainly not be harmed by them. In this respect, we have an over-riding concern that in some instances the consumer benefit has not been properly substantiated - or there is an assumption that what is in the interest of industry is also in the interest of consumers.

 

This is reinforced by our concern that, as outlined in the Commission’s response, the G10 included only one representative of a "patient-related organisation", compared with members from five Member States and four industry representatives. We would therefore not agree with the Commission’s statement that it was "composed in a balanced way". Nonetheless, we do concur with the G10’s identification of "the need to increase quality and availability of information available to patients" and "the need to improve pharmacovigilance systems that can ensure the on-going safety of medicines on the market". Additionally, we welcome a focus on "measures concerning the relative effectiveness of medicines" and "the need to increase capacity for their [patients’] collective influence and decision-making at European level."

 

Improving pharmaceutical information to patients

We welcome the Commission’s objective to "encourage the development of approved sources that people can trust". There is a great deal of information currently available to patients, but the reliability of much of this is unclear leading to increased confusion and anxiety for many patients. Where good patient information initiatives exist, they may not be widely publicised and there is little apparent sharing of good and bad practice either within member states or across the EU. We therefore welcome the Commission’s commitment to explore a range of approaches, involving the different stakeholders. We are pleased that consumer groups will be included. However, we note that organisations representing health professionals are not listed, yet health professionals clearly have an interest and knowledge in this area. We strongly suggest that they should be involved with any consultation on this that takes place.

Patient information leaflets

We also welcome the commitment to re-order the information in the patient information leaflet through the pharmaceuticals review, so that this is more meaningful to patients, and to make readability testing of leaflets mandatory. It is our view that all patient information leaflets should:

• Contain clear, concise, meaningful and explanatory information.
• Not include confusing and complex statements.
• Clearly present the risks and benefits of taking the drug in a non-alarming manner, and using a style of language that is appropriate to all patients.
• Give information about the condition at the beginning of the PIL, leaving information less relevant to the consumer at the back.
• Be available in different formats for people with learning difficulties and people who find audio and/or visual (multi-media) formats easier to assimilate; and.

• Be first tested on patients for understanding, as done in Australia, and passed only where they achieve the gold standard (whereby 20 potential users of a medicine who are given a PIL are asked to find and explain 15 pieces of information. The "gold standard’ is a leaflet where 16 out of 20 people can find and explain all the points. Only PILs that reach the gold standard are permitted.

Kite-marking

We would support and be keen to be involved in debate over the possible development of "European seals of approval for health-related websites". Since the creation in 1996 of the first major online health standards system, the Health on the Net (HON) code, many other initiatives have been established. Fourteen of these have been reviewed by the World Health Organisation including sites using self-regulation, third party accreditation and ones offering evaluation tools for users. We would therefore make the point that a new EU-wide approach to this will need to be very visible and understandable to have the desired impact and offer real benefits to consumers. Additionally, we would suggest that the value of, what is often referred to as "kite-marking" can also be applied to other sources of information, not just those available online.

However, it is very important that kite-marking is viewed as an ongoing task and not simply a case of rubberstamping. This is because information can become outdated very quickly and new research might come to light throwing existing advice into doubt. It should also be very clear to the consumer what aspects of the information have been endorsed in order to earn the "seal of approval" as public understanding of what this means may not correspond with the aspects that have been considered. For example, some may perceive the site and all its links as a sign of approval if it has a kite-mark, when in fact only certain basic information may have been vetted.

Comparative and comprehensive data on pharmaceuticals in Europe

We strongly support the need for a "better European system to facilitate the sharing of pharmaceutical date for public health, in particular, one that would enable comparative analyses to be carried out". Well-designed registers containing all relevant information on a given product are needed. These should include the results of clinical trials (positive and negative), documents relating to marketing authorisation and pharmacovigilance data. While we are aware that a number of initiatives are in development that should go some way to address this (e.g. Europharm), we are unclear what stage these are at or what involvement from patients or consumer groups there has been in this development. We strongly urge that steps be taken to ensure the involvement of patients and consumers in the design and evaluation of information provision to meet their needs.

The MINE system

Three years ago, a project was set up to explore the concept of a Medicine Information Network in Europe (MINE). The main aim of MINE was defined as being "to provide better and more accessible information about the efficacy of medicines"². MINE was intended to become a European database of information on medicinal products approved within the European Union.

The intention was that MINE would be a central database for the collation of data on drug efficacy including studies on effective prescribing and the absence of alternative drug therapies and that it would be concerned with the quality, safety and efficacy of medicines and treatment, but not their cost. Evaluation of the pilot project, in March 2001³ demonstrated a consensus amongst organisations that MINE was a basic step in improving transparency of the market and that it had the potential to make a significant contribution to the health of European citizens. Additionally, that it could provide benefits in terms of improving harmonisation of product information in the EU.

However, in order to fulfil its potential, a number of points were fed back as needing to be addressed. In particular, it was raised that the information contained within the database, as it was established was not easily understandable and the database itself was difficult to use without a good level of technical expertise. Also, that an element of interactivity, which would enable people to log their own experiences of medicines, with the aim of alerting authorities to unexpected reactions, would be a valuable addition. It was recommended that a permanent forum would need to be established to ensure consumer and patient input and that this would need to be adequately resourced.

No further developments appear to have taken place since this date, although we are unclear if this has been overtaken by the Europharm initiative, which, to our knowledge, has not involved patient or consumer representatives in its development. We are disappointed that the MINE project and the positive learning that resulted from it, appears to have been shelved. We would also strongly suggest that an overview of the different initiatives that are being undertaken should be publicised and consulted on with a wide range of stakeholders to ensure that they fulfil their potential to deliver their objectives.

Definition of commercial confidentiality

We strongly welcome the Commission’s commitment to encourage Member States to share the information that they hold on medicines with wider stakeholders, including the general public. In this regard, we believe it would be helpful to define the concept "commercial confidentiality" as, while it is understood that certain information is commercially sensitive and should not therefore be made public, it is unclear what precisely this would include. It can then be made clear by competent authorities, when they are approached for specific information about a medicine that has been licensed, rejected for license, or withdrawn, exactly what kinds of information can and cannot be provided. This would prevent information that should be in the public domain being withheld because of any confusion over this concept.

 

Public Private Partnership on patient information

While we see a role for a multi-stakeholder body in setting common standards and identifying areas where better patient information is needed, we are concerned that this body should be independent, rather than a public private partnership. Information must be high quality, unbiased, accurate and comprehensive. It should in no way seek to increase demand for a particular drug or to put commercial interests ahead of public health.

Maintaining the ban on advertising prescription medicines to the public

We strongly welcome this commitment and urge that extreme caution be taken in relation to proposing any measures that could, even inadvertently, take the EU down this route. We also urge that stronger controls be put into place to prevent attempts to circumvent the ban, for example, so-called "disease awareness" or "public education" campaigns that are sponsored by companies that produce a treatment for that condition and feature their logo. We would like to stress here that we do support public awareness campaigns, but believe that these should not be run by organisations with a clear commercial interest in increasing demand for specific treatments.

EMEA project on patient information

We welcome this project and look forward to it producing some clear actions in this area and implementing these within the next five years. We believe that a parallel process needs to take place with organisations representing health professionals and would urge that this be taken forward as soon as possible.

Public education

If patients, carers and families are to be better prepared to deal with the experience of medicine, they need to gain an understanding of the basics of treatment-taking long before the experience of actually becoming, or supporting, a patient. Such an understanding is also important in ensuring the safety and effectiveness of the use of over-the-counter medicines. Health, illness and medicine permeate the fabric of everyday life. Chronic illness affects millions, and millions more regularly take OTC (over the counter or prescription free) medications or buy magazines saturated with news and advice about health and illness. Yet few people have the skills to make the best (and safest) use of medicines, health services and information they encounter.

Currently, most health-related public education promotes healthy lifestyles and behaviours; there is little or no education about managing illness and treatment. Consequently, when trying to make sense of information about treatments, many people find themselves having to grapple with basic but often unfamiliar concepts of medicine and human physiology. They may not, therefore, be able to articulate, let alone answer, key critical questions about the use of medicines at precisely the time when an understanding of treatment-taking is most important to them.

 

Empowering patients must start in schools – equipping children with the knowledge needed to ask, challenge and ultimately self-manage. There should also be investment in broader public education about the fundamentals of medicine and pharmacology, as well as specific diseases and the experience of illness. As well as improving the safety, effectiveness and efficiency of the use of medicines and therapies, this would reduce stigmatisation, enhance informal care and prepare people for their own encounters with ill health. There is much that can be done at an EU level, as well as by Member States, to begin to tackle this critical, yet currently neglected, element of patient information.

Communication skills of health professionals

The role of health care professionals as mediators of information for patients and carers is not referred to either in the G10 report or in the Commission’s response, yet it is crucial when considering the issue of patient information. Health care professionals are central to the negotiation of key turning points in the ‘patient journey’ such as diagnosis and starting treatment. Yet, while current training programmes for health care professionals may include ‘communication skills’, much of the course content depends upon the course provider’s interpretations of ‘communication’ as to what focus is given. Courses will also vary in terms of how content is evaluated and what positive effect, if any it has had on public health.

Information-giving courses should be mandatory for health care professionals and that, with the increasing mobility of health professionals across the EU, mutual accreditation schemes should be developed and agreed with the relevant bodies

 

Strengthening the role of patients in public health decision-making

We welcome the establishment of the European Patients Forum (EPF) and the Commission’s commitment to supporting its projects and networking activities and to involving representatives in high-level decision making processes. This should provide useful input and co-ordination between patient organisations participating in the EPF for the Commission on a range of policy issues. We would also endorse the sentiment behind the original G10 recommendation in relation to the funding of patient groups – "That the Commission consider providing core funding for European patient groups to enable them to participate independently in the debate and decision making on health matters in the EU".

However, we would argue that it is important to ensure that patient organisations are truly independent of industry (or other non-patient interests). In relation to ensuring that patient group interests are legitimate we would recommend that organisations that are being considered for funding complete a declaration of interests form where they identify their membership and funding arrangements.

We also feel very strongly that there are broader policy issues, for example, general issues about access to health care, that consumer-health organisations are sometimes better placed to comment on than single-disease or groups that represent one patient constituency. This is why we believe that funding to support involvement and the process of involvement itself should not be limited to patient organisations.

Relative Effectiveness

We welcome a focus on added therapeutic value.

The notion of added therapeutic value has been precisely defined by many sources, including the Declaration on Therapeutic Advance of the International Society of Drug Bulletins in November 2001¹. In essence, a new medicinal product can be said to have added therapeutic value if sound clinical data show that it offers patients better efficacy, and/or better safety, and/or simpler administration, than existing alternatives.

The current regulatory framework does not require medicinal products to offer added therapeutic value in order to be authorised for sale on the European market. All that is required is a satisfactory balance between efficacy and safety. As a result, many new drugs are simply more or less equivalent to their predecessors. Yet it is essential for patients, healthcare professionals and health economists to know whether or not a new drug offers added therapeutic value, so that they can make rational choices among the available treatments.

Assessment reports on new medicinal products should, therefore, in our view, provide an analysis of added therapeutic value based on available data. Furthermore, failure to do so is to deprive the public of important information.

In relation to evaluations of clinical and cost effectiveness by Member States, it is, in our view, extremely important that a wider group of stakeholders, in particular, patients, are involved in the decision making process. Otherwise, this can neglect significant evidence about the impact of treatment from a patient perspective. Without this evidence, the appraisal process may rely on clinical trials, without giving enough consideration to how treatments are used – and work – in day-to-day circumstances. For example, patients with long-term medical conditions may use treatments as their condition improves – or worsens – but not all of the time. When it comes to assessing expensive treatments, this may make a difference in relation to the estimated cost of that treatment. In other cases, treatments may be prescribed for patients that fall outside of the way that they were evaluated in clinical trials.

The process of assessment itself also needs to be clear, open and transparent for stakeholders to have confidence in it. For example, patient groups feeding into this process need to be aware of the value of their evidence in relation to evidence from other stakeholders, for example on any threshold beyond which a treatment may be considered no longer cost-effective. Patient groups need feedback on how their evidence is used and on what difference it made to the outcome.

 

Pharmacovigilance

We agree wholeheartedly with the Commission that a strong pharmaceutical system is vital to ensure patient safety in relation to the use of medicines" and the recognition that this there is a need for improvement in this area.

Directive 2001/83/EEC gives the current legal basis for the system of pharmacovigilance in the EU. Pharmacovigilance can be defined as: the surveillance of authorised medicinal products by collecting and evaluating information on:

• Adverse drug reactions under normal conditions of use.
• Misuse and abuse which may have an impact on the evaluation of benefits and risks.
• Consumption of medicinal products.
• Other useful information.

EMEA has a specific role in relation to the co-ordination of national pharmacovigilance systems and with regard to centrally authorised medicines.

During the first five years of a new drug being put on the market, pharmacovigilance is particularly important, as comparatively little is known about its safety profile until it has been exposed to a much wider range of people than is possible through clinical trials and over the longer term. Additionally, the surveillance of side effects becomes all the more important with the proposed new fast track procedure.

However, throughout Europe, the level of reporting of adverse reactions has been very low (as documented through a variety of studies and sources (e.g., Salutest, April 2001⁸, The Lancet, December 2001⁹, Consumentenbond, June 2002¹⁰, UK National Audit Office, January 2003¹¹,). It has been estimated that only around 10-25 per cent of reactions experienced by patients are reported and has also been documented that these are usually the side effects that are already reasonably well known. One of the identified problems in relation to this is the key role of health professionals in reporting. Many are not fulfilling this important role for a variety of reasons. These have included lack of time, lack of clarity of whether it is their responsibility and not understanding the procedures. The impact of this is then compounded by the poor understanding that many patients have of the likelihood of different side effects occurring, as a result of badly designed patient information leaflets and little to no discussion of these with the prescriber.

This means that European citizens are being unnecessarily exposed to medicines that may not be safe for them. A more effective system of monitoring that facilitates swift action where necessary and better information sharing is desperately needed.

As a consequence, we believe that the following measures should be explored further by EMEA and Member States, as pilot projects, to assess their impact on the reporting of adverse drug reactions.

Improve patient information leaflets

Patient information leaflets need to be designed to convey potential adverse reactions more clearly, so that the relative likelihood of these occurring is included and people know what to do if they do occur.

Introduce a symbol to indicate new medicines and increased surveillance

Patient information leaflets and packs should carry an upside down black (or red) triangle if a medicine has been on the market for less than five years or is under intensive surveillance for any other reason. This kind of alert is already in use on information to prescribers in the UK, but is not also included on patient-directed information and labelling. It is will, of course, be important to raise awareness about what the symbol means in order for this to be effective.

Make reporting from health professionals compulsory across the EU

Proposed measures to make side effect reporting by health care professionals mandatory, rather than voluntary, under the current EU pharmaceuticals review should be supported.

Raise awareness about the importance of side effect reporting

Public information and education campaigns, through the EMEA and national agency websites, health centres and patient organisations, etc., on the importance of side effect reporting should be carried out and it should be a key part of training for health professionals.

Introduce a system that enables consumers to report directly to the EMEA and Member States

The EMEA and Member States should establish direct from consumer reporting, as a pilot project, looking at lessons that can be learned from national schemes, such as in Denmark and the Netherlands, and also from the Food and Drug Administration in the United States. A study referred to in the BMJ¹² concludes that patient reporting might contribute to earlier detection of known, but rare and unknown adverse reactions. Such a system could be set up through the introduction of a toll free number, a website for feedback or adding a reply form to the patient leaflet. It will need to be adequately resourced if it is to be effective.

Dutch consumer organisation, Consumentenbond, carried out a consumer survey that found strong support for a direct reporting system, in addition to reporting through health professionals. Telephone was the most favoured method of carrying out this reporting, with over half of those questioned also favouring routes for written and online feedback. One quarter wanted to be assured of anonymity in giving their feedback and one quarter wanted a system that could be used 24 hours a day. Over half also wanted some reaction, in terms of an acknowledgement and information about would happen as a result of their feedback.

In relation to the specific side effects of concern, many wanted to be more aware of those that may not be termed serious but nonetheless have a significant impact on your daily life. They were also concerned with the ease of use of the medicine itself – how easy the pill was to swallow, manageability of the packaging and when it should be taken. These aspects should also be taken into consideration as part of assessing the effectiveness of medicines, as they can all lead to patients not adhering to treatment. A pilot system of direct reporting via the internet is currently in place in the Netherlands.

Ensure full access to the EMEA pharmacovigilance database

The EMEA pharmacovigilance database should be available to health professionals, consumer and other organisations with a legitimate interest in human health and patients. Patients have the right to be informed about any potential side effect of a medicine on the market. Feedback to healthcare professionals is also important to ensure timely updating and improved circulation of information and will also demonstrate the value of the information that they submit on adverse reactions.

Carry out additional longer-term research on specific medicines

In order to focus on the potential long-term effects of new medicines and to supplement spontaneous reporting from healthcare professionals, EMEA and Member States should carry out additional research that follows a selected group of patients using specific medicines. The aim of this research would be to identify potential adverse reactions and any other difficulties with use of the medicine over time. This can be done through doctors and follow the example of similar studies being undertaken in Canada. It has also been proposed by the European Parliament as part of the EU pharmaceuticals review.

All the above measures, if implemented, should lead to a significant increase in reporting of adverse reactions and quicker and more informed action by national agencies and health care professionals as a result. They should also help to inform patients about the medicines they are taking, facilitate informed decision making between different treatment options and reduce anxiety and increase adherence to treatment as a result.

 

Access to innovative medicines

We support moves to enable patients to access truly innovative medicines quickly at affordable prices. However, this must not compromise the need for a reasonable period of proper scientific evaluation to ensure an adequate level of patient safety. Enhanced pharmacovigilance systems should also be established for these medicines, along the lines outlined above.

 

Full competition for medicines neither purchased nor reimbursed by the state

We are not in a position to give a detailed comment on these proposals. This would require a thorough analysis of the medicines market and the relationship between prices of reimbursed and non-reimbursed products - as well as the relationships between the state and private health care sectors.

However, we would question whether these proposals would simply increase incentives for drug manufacturers to push more expensive products - or products that are not proven to be clinically and cost effective - off the list of reimbursed products. We can see the benefit of this for manufacturers but are less confident that this would be beneficial for patients.

 

Competitive generic market

We support measures to increase the uptake of generic drugs, including incentives to encourage prescribers to prescribe generic medicines. We would also suggest there is much scope to increase public awareness about generic alternatives. Consumers will benefit from the increased use of generic instead of branded drugs as savings can be used to ensure that more patients have access to treatments. We also believe that a healthy generics market will help to promote competition within the pharmaceutical industry.

 

Competitive non-prescription market

We do not believe that it is in the patient's interests to be using prescription drugs unless it is necessary. Effective regulation should mean that over-the-counter drugs should have a more established track record in relation to safety - and have fewer or less significant safe-effects. We also recognise the benefits that can be gained by consumers, in relation to the non-prescription market, in terms of accessibility to medicines. However, we fully agree with the Commission that patients must have the support of good quality patient information supplied with the medicine and access to health care advice from professionals such as pharmacists as required. Furthermore, we are concerned that, in practice, moves to switch more patients to non-prescription drugs will introduce a financial incentive for drug manufacturers to switch products from prescription to non-prescription. When medicines are reclassified, we believe that this needs to be subject to public consultation, with a minimum consultation period of at least 12 weeks and that efficacy should also be considered as part of the decision as to whether to make the switch.

 

Strengthening the EU Science Base

We welcome the recognition that research needs to be carried out in areas that are considered important by society and ensuring that the research process itself is appropriate to the end use of medicine in society. In this respect, we also welcome the Commission’s commitment to "reflect further on how Europe can replicate the success of the National Institutes of Health (NIH) in the United States. We note, however, that the possible use and development of virtual institutes of health is being considered in the context of the High Level Process of Reflection on Patient Mobility and Health Care Development in the EU. This has not, to date, been a transparent or inclusive process, with respect to a wide range of stakeholders, for example, consumers.

 

Incentives for research

There is need to ensure that any incentives offered to industry for research, for example into medicines for paediatric use, are not abused by encouraging inappropriate research and thereby exposing those taking part in clinical trials to unnecessary risk.

We support the establishment of a database of European clinical trials to help communication between regulatory authorities to enable them to improve their oversight of trials and provide for enhanced protection of patients. To ensure these objectives are fulfilled, a wide range of stakeholders should be involved in the development of this database and should also have access to it once it is up and running.

A European Centre for Disease Control

We support the proposal that there may be scope for an EU version of the US Centre for Disease Control. We also agree that in addition to taking responsibility for collecting and publishing morbidity and mortality data that this organisation could take responsibility for providing independent and complete clinical information.

 

Member States learning from each other

In relation to seeking ways to improve the performance of the pharmaceutical industry, we welcome the stated focus on measuring contribution to social and public health objectives as well as industrial competitiveness. We also very much welcome the Commission’s suggestion that indicators of public health could cover performance issues related to the health care prescriber, as well as the performance of pharmaceutical products. We agree with the Commission that indicators need to be robust and easily understandable and we support the kind of approach outlined in the response communication. We would suggest that an additional focus could be looked at concerning patient safety and understanding about the use and effects of pharmaceutical products in relation to other treatments. We would also strongly suggest that the Commission involve key stakeholders, in particular organisations representing patients, consumers and public health interests, in developing these indicators.

END