Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Astellas UK Slapped on Wrist by ABPI for "Lamentable Lack of Concern for Patient Safety"

Astellas UK Slapped on Wrist by ABPI for "Lamentable Lack of Concern for Patient Safety" | Pharmaguy's Insights Into Drug Industry News |

Astellas’ U.K. unit was already suspended from the Association of the British Pharmaceutical Industry thanks to what the trade group last year called “serious breaches” of its code of practice. And now, that suspension has been extended.

The organization has tacked another 12 months onto Astellas’ penalty, it said Friday, citing cases that “have shown wholly inadequate oversight and control at both Astellas UK and Astellas Pharma Europe and a 'lamentable lack of concern for patient safety.'” And the re-suspension very nearly became an expulsion, it noted.

The extra 12 months come in response to three new cases that Astellas voluntarily served up over the course of audits this April and last September. One case “highlighted a lack of oversight and training of agency nurses who delivered patient support programs, including failing to update them with product changes,” the ABPI said. Two others focused on “failures to update and provide complete prescribing information for a number of medicines.”

All three of these instances raised “very serious concerns around patient safety,” the ABPI said, adding that Astellas UK’s “failure to understand the scale of the problem was concerning.”

As for Astellas, it said Friday that "we deeply regret our failings, and in light of this we have reinforced our focus on patient safety. We are committed to providing the highest standards of care for everyone who relies on our medicines and services."

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Most UK HCPs OK with Revealing #Pharma Payments to Docs, But...

Most UK HCPs OK with Revealing #Pharma Payments to Docs, But... | Pharmaguy's Insights Into Drug Industry News |

In a poll of more than 500 UK healthcare workers carried out for the Association of the British Pharmaceutical Industry, 87 percent believe payments from pharma companies to individually named healthcare professionals should be transparent, with around two thirds (64 percent) saying that this information should be publicly declared.


However, a significant chunk - 26 percent - felt disclosure of payments to individually named HCPs is unnecessary, and 24 percent feared the move would adversely affect medical innovation, while 26 percent also felt their relationships with pharma companies would change as a result.


The ABPI is just weeks away from publishing details of payments and benefits in kind made to UK HCPs and healthcare organisations on an online, publicly searchable database under its drive to improve transparency and trust in the industry.


Nevertheless, while being largely supportive of the move, 69 percent of respondents did express concerns about the process. The biggest concern is potential misrepresentation of data (49 percent), closely followed by possible negative perceptions among the public (44 percent), data protection (43 percent) and potential media coverage (35 percent).

Pharma Guy's insight:

I bet the poll did not ask docs if revealing payments should be mandatory. For more on that, read: "Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory?"; 

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EU and UK Physician Payment Sunshine Coming - May Eclipse US Version

EU and UK Physician Payment Sunshine Coming - May Eclipse US Version | Pharmaguy's Insights Into Drug Industry News |

In June 2012, the “code on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organisations” was announced by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Starting 1 July 2016, the Association of the British Pharmaceutical Industry (ABPI) will publish details of British pharmaceutical company payments made to healthcare professionals, including nurses and pharmacists.

This goes beyond the US Physician Payment Sunshine Act, which doesn’t require companies to publicly report payments to nurse practitioners or physician assistants, even though they are allowed to write prescriptions in most states (see here). This, however, may change if legislation proposed by Sen. Charles Grassley, R-Iowa, and Sen. Richard Blumenthal, D-Conn., becomes law. The legislation would expand the disclosure requirement beginning in 2017 to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives (read more about that here).

What do UK health professionals think of ABPI's plans to publish these data?

Click here to find out.

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Partial Transparency: 80% of Physicians Paid by Novartis OK with Public Disclosure

Over 80% of doctors and other healthcare professionals who received payments or benefits in kind from Novartis disclosed their data publically in 2015.


Novartis is proud of its collaborations. Working together with the NHS, its staff and patient groups is vital for improving outcomes for patients and ensuring they receive the best possible care. Patients benefit from these collaborations with new and improved medicines, better services and care, and clinical teams that have benefited from education.


The disclosure of payments to individuals is an industry-led initiative, which Novartis fully supports and has fully complied with by providing the Association of British Pharmaceutical Industries (ABPI) with a list of payments to be published on their common platform, where all pharmaceutical company payments to individuals and healthcare organisations in the UK are listed.


Transparency across the public sector, including healthcare, is increasingly being demanded by the general public. Novartis has made every effort to encourage all individuals to disclose details of their payments, and is committed to continuing working with all stakeholders to increase transparency around these relationships.


We believe that open communication about these interactions helps foster trust with patients, the NHS, and the public, and we are dedicated to full transparency. We are committed to working with integrity, upholding high ethical standards, and following all laws and regulations.

Pharma Guy's insight:

80% is better than 69%, which is the overall consensus of EU physicians - see"Sun Rises on UK Pharma Payments to HCPs"; But one wonders who the remaining 20% are and if they are the ones getting the biggest payments?

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Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory?

Brits Mull Over Disclosure of #Pharma Payments to Docs: Voluntary or Mandatory? | Pharmaguy's Insights Into Drug Industry News |

Pharmaceutical firms currently pay about £40m every year to healthcare professionals, including doctors and pharmacists. These payments could be for anything from expert advice to sponsoring a healthcare professional’s medical education. Now, the Association of the British Pharmaceutical Industry (ABPI) has created a central database, going live in June, on which its member companies, and others that have signed up to comply with the ABPI code of practice, will disclose who these payments are made to, and for what.


[For comparison, pharma has made over $6 Bn in payments to physicians in the U.S. in 2014. $3.2 Bn of that was for research – see chart above.]


How will this new transparency affect the complex matrix of relationships between health professionals, pharmaceutical firms, the NHS and, most importantly, patients? That was the underlying question under discussion at a seminar hosted by the Guardian and sponsored by the ABPI.


Sarah Boseley of the Guardian kicked off the discussion by pointing out that the ABPI database has already come in for some criticism: the Academy of Royal Medical Colleges says it doesn’t go far enough. But should disclosure be mandatory? Only 69% of healthcare professionals say they would agree to have their relationships with pharmaceutical companies disclosed on the publicly searchable database.


Ash Soni of the Royal Pharmaceutical Society agreed that disclosed payments need to be seen in the right context to be of value. “It’s important that there is an ability to respond and react to some of this disclosure.”


The panel members were in broad agreement that increased transparency is a good thing, whether it’s disclosing payments or publishing clinical research data – but, like Soni, Nikki Yates of GlaxoSmithKline (GSK) stressed the need for education around its issues. “The way I’ve embraced it [disclosure and transparency issues] is to take a step towards ensuring that whoever we are working with has a full understanding of why this is an important thing to do,” said Yates. Since 2014, she said, GSK has had a disclosure clause in its contracts. Thus far, it has had more than 90% agreement for disclosure of trial results. “And we’ve gone a bit further and said if we can’t agree on disclosure, then we won’t work with those individuals.”


[GSK has pledged that it will no longer pay doctors to promote its products. For more on that, read “GSK ‘Sunshine Blocks’ Outside Docs: No More $ For You!”;]


But GP Dr Margaret McCartney pointed out that talking about shared goals, partnership and collaboration is all very well – but what are the shared goals and who decides what they are? She cited the pharmaceutical researcher who had approached her practice to do clinical research. When McCartney asked him if results would be published no matter what they showed, she was told no, and that McCartney herself would not be allowed to make them public. “How can I trust a leadership that says it will not guarantee published results, no matter what they show?” she asked.

So should disclosure be required by law? McCartney said she was pleased with GSK’s advances in making clinical data public, but believed that the process has to be “enshrined in law”. Others were not so sure: Jackson was concerned with “over-sterilisation” of the system. “… if we legislate, and go too far, then we could end up stifling the system by not allowing it to breathe.”


Transparency in the interest of patients

But times are changing, said Soni. “The industry did have a very bad reputation and there is no doubt that it earned it. Some of the things it did were not in the interests of patients or for the best interests of care. However, the industry has changed – it’s had to. It had to realise some of the things it was doing were not of a suitable standard. And I think this is helping us to move further and further in the right direction.”


George Freeman, minister for life sciences took up this theme in his keynote address… “We have a choice between historically justifiable conspiracy theory, distrust and legislation as the only solution – the law or the threat of law, which I think drives defensiveness – or an approach based on mutual respect for others’ perspectives. [That approach] will accelerate us into this landscape of a more transparent healthcare ecosystem, which I think is genuinely in the interests of all of us.”

Pharma Guy's insight:

It seems to me that only mandatory laws requiring full disclosure of payments to physicians is the only way to go to achieve the type of "full transparency" that was bandied about by this panel. Recall that before the Sunshine Law took effect in the U.S. only a few pharma companies disclosed payments and only because they were required to do so by law. But more telling was the fact that the disclosures themselves were not transparent - several different data formats were used and some datasets were impossible to download for independent analysis and were not easily searchable (for more on that, read "Transparency Vs. Translucency in Reporting Physician Payments"; The Sunshine Law changed all that!

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Most UK HCPs Back ABPI's Plan to Publish Pharma Industry Payments to Doctors, Nurses, and Pharmacists

Most UK HCPs Back ABPI's Plan to Publish Pharma Industry Payments to Doctors, Nurses, and Pharmacists | Pharmaguy's Insights Into Drug Industry News |

Most clinicians back moves to make payments received from pharma companies more transparent, finds a survey commissioned by the industry body, the Association of the British Pharmaceutical Industry (ABPI).

But a significant minority of GP respondents said they would be less likely to work with pharma companies as a result, finds the poll, carried out by the ComRes consultancy.

Among 500 healthcare professionals questioned, including 127 GPs and similar numbers of hospital pharmacists, nurses, and specialists, 87% agreed that payments from pharmaceutical companies to individually named healthcare professionals should be transparent. 

Seven out of ten (69%) with a current relationship with one or more pharma companies said that they have already given or are likely to give permission for the companies they work with to disclose their payment information.

The survey results come amid preparations to disclose details of payments and other transfers of value pharmaceutical companies have made to individual healthcare professionals and healthcare organisations this year on a publicly accessible, searchable database that will be hosted on the ABPI's website from June 2016.


The initiative is part of a Europe-wide programme to boost transparency in respect of the relationships between the industry and the healthcare sector.

Dr Virginia Acha, the ABPI’s Executive Director Research, Medical and Innovation, said that these relationships were important for the development of new treatments and patient care.

Nevertheless, one in three (32%) of those questioned felt it unnecessary to declare payments from pharmaceutical companies to individually named healthcare professionals, while one in four (26%) believe that declaring these payments will adversely affect medical innovation. 

Three out of four said that the disclosure of payments from pharmaceutical companies will have no effect on their relationship with these companies, but views differed according to professional group, the survey found.

Around a quarter (23%) of the GPs said they would be less likely to work with the industry in the future as a result of the publication of these data, which is considerably higher than hospital specialists (17%), pharmacists (10%) or nurses (6%).

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