Annual Report

2010Haute Autorité de Santé

Summary

Exchanging ideas,HAS Plan 2009-2011:

midway progress reportThe HAS strategic plan for 2009-2011 includes provisionfor a mid-term progress report. This consists of a detailedlist that is broken down by type of activity, level of progressachieved and the extent to which HAS’ defined goalshave been met. This progress report shows that the HASroadmap has been followed, and that the institution’sdepartments have been fully involved.

,Regional days In 2010, HAS has continued to honour the commitmentit has made to healthcare professionals to improve carequality and patient safety, with three regional days,organised in partnership with regional evaluation bodies(the Loire region quality network, CEPPRAL andCCECQUA).

,Public hearing on “Exposure to asbestos”On 19 January 2010, HAS held a public hearing at theMinistry of Health, about post-occupational follow-upfor workers who have been exposed to asbestos.Given the medical and social challenges involved inthis issue, the report that resulted from the hearingsuggests around thirty recommendations to improvescreening and post-occupational follow-up for thosewho have been exposed.

AchievementsPutting quality at the heart of individualpractice and behaviour

,Pilot programmesIntegrated or “pilot” programmes are the result of jointwork with healthcare professionals, and look at clinicalimpact for patients, using an approach that involves allthree dimensions of care quality: clinical effectiveness,safety and access to care. In 2010, HAS continued itswork on myocardial infarction and the prevention and riskreduction of iatrogenicity, and has developed two pilotprogrammes:• “Together, we can improve how we manage stroke”[“Ensemble améliorons la prise en charge de l’accidentvasculaire cérébral”] is continuing, with the creation of 41clinical practice indicators (CPI), which are shared waysof measuring the quality of practice. These have beenintegrated into the tools used in the Stroke Action Plan for2010-2014, and are presented for healthcareprofessionals on the HAS website, together with the restof the Stroke Action Plan.• “Detecting and controlling treatment-related problemsin Alzheimer’s disease”. HAS developed this programmejointly with professionals from the health sector and fromother institutions, as part of the French NationalAlzheimer’s Plan. The aim is to identify and count patientswho are on antipsychotic treatments (Detection) and toevaluate whether the prescription is appropriate(Prescription control). An information brochure, createdby programme partners, about the role of antipsychoticsand non-drug alternatives in Alzheimer’s and relateddiseases, is available on the HAS website.

,Good practice guidelinesIn 2010, HAS began the process of updating itsmethodology guides for the production of good practiceguidelines. This work was done jointly with healthcareprofessionals and patient associations. Among theguidelines published this year were one on themanagement of anorexia nervosa and one on high-riskpregnancy.

2010 Highlights

HAS is pleased to present its Annual Report for 2010 in a summarised form, making it more accessible and in keepingwith its requirement to adhere to the values of sustainable development.The main activities carried out by HAS in 2010 are described in this document.For more information or clarification, you can consult the full version (in French) of the Annual Report 2010 on

the HAS website: www.has-sante.fr, by clicking on the heading - Présentation de la HAS.

HAS 2010 annual report

HAS Meetings in 2010Approximately 1600 people (professionals,representatives of patients’ associations and of institutions) took part in the 4th HAS Annual Meeting in December 2010. Information forpatients was central to these days, and two plenarysessions were devoted to this subject. Videos, highlights and slides from the plenaries and the 23 round-table sessions can be found underMeetings on the HAS website, www.has-sante.fr, by clicking on the heading - “Evénements”.The next HAS Annual Meeting will take place in Lyon, on 17 and 18 November 2011.

,Continuing professional development(CPD)

As part of its close collaboration with doctors’representatives, HAS has created an initial list of usefulactions to support continuing professional developmentprogrammes.

,Co-operation between healthcareprofessionals

Development of new forms of cooperation betweenhealthcare professionals was included in the French lawon hospitals, patients, health and the regions (HPST).Regional health agencies and HAS are at the heart of thenew provision, and HAS has suggested practical toolsthat can be used by healthcare professionals. In order tohelp these professionals to create a protocol for jointworking, HAS has published two methodology guides.

,Computerised clinical decision support systems (CDSS)

HAS has studied the role of the computerised clinicaldecision support systems (CDSS) that are available inFrance and elsewhere. The study was published inOctober 2010. It provided starting points for rolling outCDSS in France, and gave recommendations for ways inwhich development of such systems could contribute tocare quality.

,Long-term conditions and patientsupport

In 2010, in partnership with the French National CancerInstitute (INCa), HAS completed its cancer guidelines,which aim to improve the management of patients withcancer who are enrolled in the long-term conditionscheme. In addition, as part of its new remit to evaluatepatient therapeutic education programmes (provision forwhich is contained in the HPST law), HAS has suggestedan evaluation grid that will help regional health agenciesto evaluate requests for programme authorisation.

Putting quality at the heart of the decision-making process

,Health economics assessmentHAS has continued its health economics assessmentwork, carrying out 18 studies in 2010. HAS proposed aguide to the principles and methods of economicevaluation within the institution, which led to a publicconsultation on the HAS website. One of the mostprominent studies of the year was an evaluation of theeffectiveness and cost-efficiency of statins, which waspublished in July 2010.

,Assessment of medicinesThe Transparency Committee issued 795 opinions in2010, as part of its remit to evaluate drugs in order toprovide an opinion as to whether they should bereimbursed, and to promote their proper use. Through itswebsite, the committee also made available to healthcareprofessionals 81 summary opinions and 3 drug “good useguides”. The Committee also re-evaluated threecategories of pharmaceuticals: the ones indicated asdisease-modifying treatment for multiple sclerosis, forpulmonary arterial hypertension (PAH) and forosteoporosis. The committee also considered that, of the130 new drugs it evaluated, 14 provided an improvementin treatment.

,Assessment of medical devicesThe National Committee for the Assessment of MedicalDevices and Health Technologies (CNEDiMTS) issued 159opinions in 2010 and has continued to assess medicaldevices, while reducing by one third the average lead timefor dealing with requests for inclusion on reimbursementlists (99 days). Among the most notable assessments thisyear was the evaluation of a negative pressure treatmentsystem; this clarified proper usage of this technique,which is useful in a limited and precise range of situations.A Good Practice document has been created forpractitioners. Since March 2010, the Committee hasprovided healthcare professionals with a new informationtool dedicated to good medical device practice: summaryopinions.

,Assessment of clinical procedures and health technologies

In 2010, HAS assessed indications and contraindicationsfor common procedures, in order to clarify good practices(e.g. measurement of cardiac markers) and conditionsunder which procedures should be carried out (e.g.cataract surgery). It also assessed innovative techniquessuch as virtual colonoscopy, in order to provide an opinionas to whether these should be reimbursed by FrenchNational Health Insurance.

Health product manufacturersand patient associationsThe HPST law obliges health product manufacturers,from 2010, to declare to HAS any financial supportgiven to patient associations. Declarations of supportprovided in 2009 are online on the HAS website.These show that all involved are keen to achievegreater transparency. HAS submitted to thegovernment its proposals for adapting the tool; if these are implemented, the declaration would onlybe obligatory for those manufacturers that supportassociations, the scope of support would be moreprecisely defined, and consideration would be given as to whether sanctions should be required if declarations are not made.

HAS 2010 annual report

,Accreditation of healthcareorganisations

HAS carried out an initial assessment of the launch of thenew version of the accreditation procedure for healthcareorganisations (V2010), which has been received positively.An external organisation, the International Society forQuality in Health Care (ISQua), was called in by HAS toassess its V2010 standards and accreditation procedures.This additional accreditation reflects HAS’ willingness tobe subjected to the same demands, in terms of qualityprocedures, as the organisations it assesses.

,Certification of doctors HAS’ programme of certification of doctors has been wellreceived: one third of eligible healthcare professionalshave applied for certification, four years after theprocedure was first introduced. In November 2010, HASpublished risk reduction programmes of the 17 bodiesapproved for the certification of doctors on its website.

,Indicators in healthcare organisationsHAS has published the results of its second campaignaimed at extending the use of quality indicators to allhealthcare organisations (MSO and CCR), along with ananalysis of associated factors and of the variability of theresults. Another significant event this year was the nationalpublication of HAS’ quality indicators on the “Platines” siteof the Ministry of Health. The findings were also madeavailable to the public by healthcare organisationsthemselves.

,Cervical cancerHAS is advising the public authorities that a nationalscreening programme for cervical cancer be organised,as national programmes have been shown to be moreeffective than individual screening. This new measuredoes not mean that women should no longer attend for

cervical smears every three years. HAS recommends ascreening programme based on the following four points:(I) use existing providers of screening and specifymethods to be used; (II) improve the quality of screening;(III) strengthen current measures; (IV) and adapt to regionaland population-specific requirements.

,Patient safetyHAS is unwavering in its commitment to care quality andpatient safety, both in Europe and internationally. In 2010,HAS continued to play the role of European co-ordinatorfor the EUNetPaS (European Network for Patient Safety)project to improve patient safety, the results of which werepresented in Brussels in July. It is also co-ordinating the“High 5s” project in France. This WHO project aims toimprove patient safety in hospitals by implementingstandardised protocols. Eighteen healthcareorganisations volunteered to implement two standardisedprotocols to prevent procedure and site errors in surgery,and to improve prescription safety at transitional stagesof the care pathway.

Improving HAS’ performance,transparency and expertise

,HAS institutional partnershipsHAS has continued its policy of cooperation with itsinstitutional partners by creating two new agreements:with the French Blood Institute (EFS) to improvetransfusion safety, and with the French BiomedicineAgency to improve care quality.

,Partnerships with national specialistbodies

HAS has pursued its policy of co-operation with nationalprofessional bodies and the Board of General Medicineand has increased the involvement of professionals inmeasures to improve practice. In particular, this has beendone by creating clinical data registries, by identifying andpromoting useful methods, and by involving professionalsin the creation of good practice guidelines andprogrammes.

,Managing conflicts of interestOne of HAS’ main concerns, is to ensure that the adviceit provides is independent, and that conflicts of interestare effectively prevented. In 2010, HAS continued toimprove its internal procedures in this area. Its guide fordeclaration of interests and prevention of conflicts ofinterest has been updated.

,Management governanceIn 2009, institutional indicators of work volume, lead timesand cost were put in place for the main areas of HAS’activity. Following this initial successful step, in 2010 thiswas extended to all departments, increasing involvementby actors, professional services and support services.

HAS 2010 annual report

As part of its activities overseeing the accrediation ofhealthcare organisations, HAS worked in several majorareas in 2010, including ”bientraitance” (or “ethicalcare”) and quality of life at work in organisations. The notion of “bientraitance designates a dimension of quality and an institutional policy that comprises: 1. Commitment by hospital leaders to firmly addressmistreatment and to establish a culture of care; 2. Training of professionals in appropriatecommunication with patients; 3. Concrete actions toimprove everyday life in hospitals and to betterrespond to patients’ needs and values. The results of aqualitative study on patient experience in healthcareorganisations was published at the end of January2010. The conclusions of this study were incorporatedinto the new accreditation procedure (V2010). Inaddition, HAS conducted a seminar in October 2010on the “Quality of life at work and care quality inhealthcare organisations”.

”Bientraitance” and quality of work life

Assessment of medicines

795 Transparency Committee opinions3 Good Use Guides and 1 class guide 81 summaries of scientific opinions83 days: average time for examining requests for inclusion on reimbursement lists

Assessment of medical devices

159 opinions from the National Committee for theAssessment of Medical Devices and Health Technologies

12 opinions or reports about homogeneous groups of products

33 summaries of scientific opinions99 days: average time for examining requests forinclusion on reimbursement lists

5 Good Use guides

Assessing clinical procedures and health technologies

45 opinions from the Committee for the Assessment of Clinical Procedures

20 technological assessments11 Good Use Guides for health technologies

Economic and Public Health Assessment

18 economic assessments6 public health guidelines

Assessing medical, economic and publichealth aspects

Improving the quality and safety of healthcareGood practice guidelines

9 good practice guidelines for professionals, 1 of whichwas carried out in partnership

4 methodology guides and 5 methodological files

Chronic conditions

15 guides for doctors (including 5 national protocols forthe diagnosis and treatment of rare diseases)

14 patient guides44 updates to the lists of procedures and services

Pilot programmes

5 programmes in progress: • Stroke • Myocardial infarction• Prescription of medicines for the elderly (PMSA, treatment-related problems).• Prescription of psychotropic drugs for the elderly(Psycho-SA, AMI-Alzheimer)• Localised prostate cancer

Assessment and improvement of clinicalpractice*

17 bodies approved for the certification of doctors9786 doctors involved in the scheme6654 doctors obtained certification from HAS

Accreditation of healthcare organisations

537 healthcare organisations with V2/V2007accreditation

180 healthcare organisations with V2010 accreditation730 surveyors operating at the end of December 2010

Quality improvement indicators

1185 healthcare organisations involved in generalmedicine, surgery and obstetrics (MSO)

12 indicators collected for the MSO sector1142 healthcare organisations involved in continuingcare and rehabilitation (CCR)

5 indicators collected for the CCR sector

Key figures 2010

HAS 2010 annual report

* Aggregate figures since 2007

HAS ProfileStatut� Independent public scientific authority withfinancial autonomy.

Creation� Established on 1st January 2005 under the law of 13th August 2004.

Resources� It has 410 full time equivalent staff, including halffrom a health background.

� A pool of more than 3000 external healthcareexperts and professionals is available, including726 surveyors.

Organisation� Board of eight members, chaired by Professor Jean-Luc Harousseau.

� Eight specialist committees.

� Four management divisions managed by Mr François Romaneix.

Budget� 63.8 million euros allocated for operational costs in 2010.

� HAS improves care quality by promoting safety, effec-tiveness and accessibility of care. It supports healthcareprofessionals in constantly improving their clinical prac-tice, both in healthcare organisations and in individualpractices.

� Through the opinions that it issues, it supports publicdecision-makers in optimising management of the rangeof medical products and services eligible for reimburse-ment, thereby preserving in the long term the fair andsupportive funding of the French healthcare system.

� It promotes good practice and good use of healthcare.It provides information for the general public and helpsto improve the quality of medical information.

Areas in which HAS plays a role:

� Assessment of the medical benefit and the improve-ment of the actual clinical benefit of medicines, medicaldevices and clinical procedures covered by French Na-tional Health Insurance

� Economic and public health assessment

� Production of clinical guidelines and guides for manag-ing chronic conditions

� Accreditation of healthcare organisations

� Continuing professional development and certificationof doctors and medical teams working in disciplines in-volving risk

� Assessment of therapeutic education programmes andanalysing co-operation protocols drawn up betweenhealthcare professionals

� Improvement of the quality of medical information: certification of medical sales visits, e-health websitesand prescription software

www.has-sante.fr2, avenue du Stade de France - 93218 Saint-Denis La Plaine CEDEX

Tél. : +33 (0) 1 55 93 70 00 - Fax : +33 (0)1 55 93 74 00

You can obtain a copy of the full version (in French) of the HAS 2010 AnnualReport on the HAS website: www.has-sante.fr,

by clicking on ‘Présentation de la HAS’

Dépôt légal : Novembre 2011 - RAC10

- Crédit photo © BSIP/ASTIER, CHRU LILLE

The nature of HAS' objectives impose the particular requirementthat it be independent and impartial with regard to all thoseinvolved in procedures relating to decision-making, givingopinions and making recommendations.

The Code of Practice drawn up by the “Ethics and independentexpertise” group and approved by the Board in November2008, provides a reference framework for all those involved inHAS activities in terms of the behaviour and practices to beadopted when carrying out their tasks. As it is a real code ofconduct, it also aims to stipulate the ethical obligations thatthese people must fulfil.

These rules supplement the ethical rules which already apply tothem as a result of their status or profession.

This code applies to everyone involved in HAS activities:members of the Board, members of the specialist committees,staff employed under both public and private contracts, whetherfor a specified period or indefinitely, trainees, temporary andholiday staff, experts and other people occasionally involved inHAS’s activities.

You can obtain a copy of the full version (in French) of the HASCode of Practice from the HAS website: www.has-sante.fr, byclicking on the ‘Déontologie’ (Ethics) link and then the Heading‘Présentation de la HAS’.

HAS Code of Practice