5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK
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5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK
Tout (ou presque) sur la Loi BERTRAND - Almost everything on Sunshine Act
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Sunshine Act - IL Y A COMME UN RAYON DE SOLEIL AUJOURD'HUI.... - PHARMAGEEK

Sunshine Act - IL Y A COMME UN RAYON DE SOLEIL AUJOURD'HUI.... - PHARMAGEEK | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Lionel Reichardt / le Pharmageek's insight:

Ca y est !! enfin… le décret sur le « Sunshine Act » à la Française ou La « Loi Bertrand » du nom de son initiateur a été publié ce matin au Journal Officiel.(JORF n°0116 du 22 mai 2013 page 8407 texte n° 6)


De son intitulé exact : « Décret n° 2013-414 du 21 mai 2013 relatif à la transparence des avantages accordés par les entreprises produisant ou commercialisant des produits à finalité sanitaire et cosmétique destinés à l’homme   » ; il définit les obligations en matière de transparence des liens d’intérêts entre entreprises et professionnels de santé .


LE CALME APRES LA TEMPÊTE ?


Publié en pleine affaire Cahuzac, alors que le procès Médiator reprend de plus belle et que l’EMA vient de prendre une position différente de la France sur Diane 35 (retirée depuis hier des officines françaises), ce décret  était attendu depuis des mois.


Il est l’une des pierre angulaire de la loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé promulguée le 30 décembre 2011 et était devenu « un caillou dans la chaussure du gouvernement » depuis la lettre ouverte du 13 mai dernier de Xavier Bertrand à Jean marc Hérault.


Qui plus est, il s’inscrit dans une démarche globale puisque le Sunshine Act aux USA vient d’être mis en place début 2013 et que l’ESHLSG de nos voisins anglais vient de finir sa consultation des acteurs sur le sujet.


NE DITES PAS A MA MERE QUE JE TRAVAILLE DANS LA PHARMA, ELLE ME CROIT PIANISTE DANS UN BORDEL


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UK pharma Code of Practice to change with digital times - #esante #hcsmeufr #digitalhealth 

UK pharma Code of Practice to change with digital times - #esante #hcsmeufr #digitalhealth  | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it

K pharma industry organisation the ABPI has unveiled proposed changes to its Code of Practice, aimed at reflecting changes industry practices and relations with healthcare professionals.

There are 45 proposed amendments to the Code in total in the consultation, covering a wide range of industry practices. These include the growth of conditional marketing licences, discussions with the NHS about 'service redesign', the certification of digital materials, the provision of services and genetic tests to the NHS, as well as updates to how healthcare professionals are asked to disclosure payments from pharma.

Mike Thompson, chief executive of the ABPI, said: “In the 60th anniversary year of the ABPI Code, the 70th anniversary of the ABPI and the 25th anniversary year of the PMCPA, we are proud to launch this open-to-all consultation.


The ABPI's Mike Thompson

“The views of those we work with are very important to us - including the NHS, health professionals, patient organisations, regulators and government as well as the pharmaceutical industry.

“We look forward to receiving contributions and comments on this important consultation.”

One notable amendment aims to clarify the marketing of medicines granted a conditional licence, an increasingly common occurrence, especially in cancer therapies. The proposed changes clarify that a conditionally approved treatment can be promoted, but that it must be clearly communicated that it is approved on a conditional licence.

Another amendments is looking to free-up the compliance process within pharmaceutical companies.

The current code of practice states that printed promotional material based off an already-certified digital version still requires a subsequent signatory.

However, the new amendment proposes removing this rule, to allow the printed material to be checked by an appropriately qualified person, rather than a signatory.

Speeding up the compliance process was also tried and tested following the Code’s 2016 amendment, which only required one suitably qualified person to sign off on promotional materials, abolishing the previous two-signatories rule.

Despite the close attention paid to complying with Code, some major transgressions still regularly occur. Earlier this year, Martindale Pharma, Pierre Fabre, Janssen and Pharmasure were all named in adverts following serious breaches the Code. These cases included instances of promoting an unapproved medicine and providing healthcare professionals with a hamper of chocolates.

Heather Simmonds, director of the PMCPA, said: “The ABPI Code of Practice is a living document, which is regularly updated. It reflects UK law and other requirements, such as international and European Codes to support high quality patient care. We always welcome views on its content and operation to ensure high standards and that confidence in self-regulation is maintained."

Once the consultation closes, the ABPI Board will agree on final proposals, which will be voted on by the ABPI and member companies. The code is also expected to see further changes next year to remain in line with changes from the IFPMA and EFPIA codes.

The updated code is expected to come into operation at the beginning of January 2019, with a proposed transition period until the end of April 2019.


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Ontario law to require drug firms to reveal funds paid to doctors’ groups, patient advocates

Ontario law to require drug firms to reveal funds paid to doctors’ groups, patient advocates | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Right now, Canadian patient-advocacy groups can disclose as much or as little as they like about the donations they receive from drug or device makers. Some make detailed disclosures on their websi…

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New Jersey Finalizes “Gift” Ban of Physicians Working with the Pharmaceutical Industry

New Jersey Finalizes “Gift” Ban of Physicians Working with the Pharmaceutical Industry | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
In an unusual administrative move – without passing any new laws – on December 22, 2017, the Attorney General of New Jersey finalized new rules governing physician interactions with pharmaceutical …

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Les facultés de médecine se dotent d’une charte éthique

Les facultés de médecine se dotent d’une charte éthique | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Épinglés en janvier pour leur manque d’actions contre les conflits d’intérêts avec les laboratoires pharmaceutiques, les doyens des facs de médecine et d’odontologie ont voté un texte commun. « L’i…

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Canada | More Transparency In Health Care: Ontario’s Proposed « Sunshine » Legislation

Canada | More Transparency In Health Care: Ontario’s Proposed « Sunshine » Legislation | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
The Ontario Government introduced a bill on September 27 to enact legislation aimed at strengthening transparency in Ontario’s health care sector. The Health Sector Payment Transparency Act, …

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2016 CMS Open Payments (Sunshine Act) data published today : $8.18 billion !

2016 CMS Open Payments (Sunshine Act) data published today : $8.18 billion ! | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
To explore Open Payments Data

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Conflict-of-Interest Rules Are Holding Back Medical Breakthroughs

Conflict-of-Interest Rules Are Holding Back Medical Breakthroughs | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Researchers and companies have to work together.

 

Few issues are more foundational to driving improvements in human health than creating productive, progressive relationships between clinical medicine and the biopharmaceutical industry. The big public health problems that humanity faces today — including Alzheimer’s disease, cancer, and metabolic and infectious disease — will not be solved by either sector working in a silo. But the interface between the two has never been more tense. Legitimate concerns over conflict of interest that have resulted in overly extreme preventative policies are a central cause. It is time for all parties to revisit those policies and replace them with rules that recognize both true conflicts and true confluences of interest. They are essential to forging the strong collaborations that are worthy of society’s trust.


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Canada : Open Pharma wants public to know ties between MDs and pharmaceutical industry

Canada : Open Pharma wants public to know ties between MDs and pharmaceutical industry | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Canada is seen as an international “laggard” when it comes to transparency about financial ties between the pharmaceutical industry and physicians. If you live in the United States, you can easily …

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New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017 | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health. The Sunshine Act intr…

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Le décret relatif à la transparence des avantages accordés par les laboratoires vétérinaires est paru !

Le décret relatif à la transparence des avantages accordés par les laboratoires vétérinaires est paru ! | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Publics concernés : entreprises produisant ou commercialisant des médicaments vétérinaires ou assurant des prestations associées à ces produits ; vétérinaires, pharmaciens, groupements agréés menti…

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Should cancer doctors disclose financial conflicts of interest when they tweet?

Should cancer doctors disclose financial conflicts of interest when they tweet? | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it

Conversations centered on health care are increasingly taking place on social media. For example, doctors, patients, advocates, the FDA and members of the pharmaceutical industry frequently interact on Twitter, discussing new drugs and devices. 

Research has shown that 60 percent of physician tweets are health-related and 14 percent mention commercial products or services. What wasn’t widely known, until now, is those physicians may have financial conflicts of interest with industry they are not disclosing.  

Vinay Prasad, M.D., M.P.H., an assistant professor of medicine (hematology and medical oncology) in the OHSU School of Medicine and member of the OHSU Knight Cancer Institute, noticed potential financial conflicts of interest, or FCOI, among physicians on Twitter and realized the issue had never been formally studied. To remedy that, Prasad and colleagues investigated the prevalence of FCOI among hematologist-oncologists active on Twitter. Their findings are published today in JAMA Internal Medicine.

Prasad and team examined 57,515 Twitter accounts, assessing 634 hematologist-oncologists for FCOI. They found 72.4 percent of those users received “general payments” from industry, i.e., payments for consulting, travel, lodging, food and beverage. Of those, 62.6 percent received more than $100 in general payments and 44.3 percent received $1,000 in general payments.

The results raise an intriguing question: How should conflict of interest be disclosed and managed in an age where information, interpretation and criticism of cancer products and practices increasingly occur on social media?

“Should there be policies to disclose conflict or policies beyond disclosures? We know social media is not going away, so how do we ensure transparency among physicians and researchers?" Prasad asks.


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Transparence : les contrats entre médecins et industries rendus publics

Transparence : les contrats entre médecins et industries rendus publics | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Le montant des contrats établis entre les laboratoires et les professionnels de santé, experts sanitaires, ou associations devront être rendus publics avant le mois d’avril 2017.

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Loi sur le secret des affaires : l'agence des médicaments censure des documents liés au Levothyrox .

Loi sur le secret des affaires : l'agence des médicaments censure des documents liés au Levothyrox . | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
L'agence nationale du médicament, sommée par la justice de produire des documents sur le Levothyrox, substitut hormonal au cœur d'un scandale sanitaire, les a caviardé au nom de la loi sur le secret des affaires. C'est une première.

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The potential for conflict of interest when health policy experts also serve on the boards of pharma companies

The potential for conflict of interest when health policy experts also serve on the boards of pharma companies | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it

The issue of conflicts of interest has become more pressing in recent years as drug prices soar and healthcare companies reach out to the academic and policy community for advice — often with generous payments attached, ethics experts say.

When Dr. Mark McClellan sat for an in-depth 30-minute question-and-answer session at an April health policy forum, the audience was filled with top researchers, advocates and Capitol Hill staffers eager to hear what insight the former head of the Food and Drug Administration would dispense.

He did not disappoint.

In response to a question about how competition might drive down the cost of new drugs made from living cells, McClellan said, “That is a great example of where more clarity from FDA about what exactly is required could potentially open up more biosimilar competition.”

McClellan is director of the Margolis Center for Health Policy at Duke University, the academic position by which he’s commonly identified. But he frequently has not disclosed another position he’s held since late 2013: He earned $285,000 last year on the board of pharmaceutical giant Johnson & Johnson, a company accused of blocking the sale of Pfizer’s Inflectra biosimilar, which competes against J&J’s blockbuster Remicade, a rheumatoid arthritis drug.


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The D.C. Pharma Lobbying Swamp is Bigger & More Slimy Than Ever! PhRMA & BIO Set a New Record in 2017

The D.C. Pharma Lobbying Swamp is Bigger & More Slimy Than Ever! PhRMA & BIO Set a New Record in 2017 | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it

The two big groups that lobby on behalf of drug companies set a new record for their collective spending in the first year of the Trump administration.

Shelling out a combined sum of nearly $35 million to lobby the federal government in 2017, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization upped their expenditures at a time when the sweeping tax overhaul was on the line and fears of a crackdown on drug pricing were top of mind. Remarkably, however, the record-setting spending push came in spite of the fact that neither group took a position on the biggest health policy story of the year, the long and steady Republican quest to repeal and replace the Affordable Care Act.

PhRMA came just short of breaking its own record. The group spent more than $25 million — just about $700,000 shy of its spending total in 2009, at the height of the debate over the ACA in the first year of the Obama administration. BIO spent more than $9 million, the most since at least 1999, the earliest year quarterly lobbying spending is available online for the two organizations.

The groups spent their lobbying dollars on some of the issues that generated big headlines of 2017: the new law that rewrote the tax code. Legislation concerning drug pricing. Right-to-try. Drug importation. Accelerated pathways for drug approvals. Policy issues around incentives to encourage development of drugs for rare diseases. And the confirmation of Alex Azar, President Trump’s pick to lead the Health and Human Services Department. 

 

Click here (subscription required) to see the TOP 15 Pharma company lobbyists!


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Pharma Guy's curator insight, January 24, 7:48 AM

This swamp will never be drained! The "PharmaGovernment Complex" is alive and well!

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Loi « anti-cadeaux » : un an de prison avec sursis contre un professionnel de santé !

Loi « anti-cadeaux » :  un an de prison avec sursis contre un professionnel de santé ! | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Sébastien Pradeau, spécialiste du droit de la santé et Of Counsel au sein du cabinet Fieldfischer, nous signale qu’aujourd’hui mardi 28 novembre 2017, un tribunal correctionnel a condam…

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Les ratés de la base de données publique Transparence Santé

Le site Internet censé donner les liens entre laboratoires et professionnels regorge d’erreurs et d’incohérences. Des données erronées publiées sans vérification : en parcourant les données de la b…

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« Cadeaux » des laboratoires : les médecins sous influence

« Cadeaux » des laboratoires : les médecins sous influence | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Quelle que soit la valeur du cadeau offert par un laboratoire pharmaceutique, les professionnels de santé changent leur manière de prescrire avec plus de médicaments, plus chers. 
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Drugmakers’ Payments to U.K. Health Groups and Doctors Climb 25%

Drugmakers in the U.K. led by AstraZeneca Plc increased payments to local health-care organizations, doctors and other workers by 25 percent last year,with most of that money going toward research …

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JAMA | Conflict of Interest: Why Does It Matter?

JAMA | Conflict of Interest: Why Does It Matter? | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
While endeavoring to protect the interests and well-being of their patients and maintain professional competence, physicians may develop secondary interests such as the competition for patients and…

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Conflits d'intérêt dans la santé : une prévention renforcée et étendue à de nouveaux professionnels du secteur

Conflits d'intérêt dans la santé : une prévention renforcée et étendue à de nouveaux professionnels du secteur | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it

Une récente étude réalisée par FORMINDEP a classé les facultés de médecine en matière d’indépendance vis-à-vis des industriels de la santé et a relevé de nombreux manquements. Par ailleurs des textes récemment publiés traitent de sujets touchant à la prévention des conflits d’intérêt ainsi que des relations entre les professionnels du secteur de la santé et les industriels. C’est donc l’occasion de présenter (succinctement ici) ces nouvelles dispositions ou de revenir sur les règles qui régissent ces sujets.

Après avoir rappelé les règles déontologiques générales (1), nous préciserons quelles sont les fonctions nouvellement concernées par l’obligation de déclaration d’intérêt (2). Nous évoquerons les nouvelles règles encadrant les avantages consentis par les entreprises (3) puis les obligations de publication des conventions passées par ces mêmes entreprises (4).


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The dark side of transparency | McKinsey & Company

The dark side of transparency | McKinsey & Company | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Executives need to get smarter about when to open up and when to withhold information so they can enjoy the benefits of organizational transparency while mitigating its unintended consequences.
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Articles du CSP modifiés par l’Ordonnance n°2017-49

Articles du CSP modifiés par l’Ordonnance n°2017-49 | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
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L’enseignement médical sous influence en France

L’enseignement médical sous influence en France | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Aucune faculté de médecine n’encadre les interactions entre enseignants, étudiants et firmes pharmaceutiques.
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Le décret portant sur la transparence des avantages et sur la déclaration publique d’intérêts est (enfin) paru !

Le décret portant sur la transparence des avantages et sur la déclaration publique d’intérêts est (enfin) paru ! | 5- SUNSHINE ACT & LA LOI BERTRAND by PHARMAGEEK | Scoop.it
Décret N°2016-1939 du 28 décembre 2016 relatif à la déclaration publique d’intérêts prévue à l’article L. 1451-1 du code de la santé publique et à la transparence des avantages accordés par les ent…

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