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What is new in pharma compliance?

What is new in pharma compliance?

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Undoubtedly, the farma theme attracts crowds in our industry. There was a full room for the session organized by OPC Spain in the Pio XII Ilunion of Madrid: more than a hundred professionals came to better understand the evolution of ethical codes in pharmaceutical meetings and congresses, and get a bit of reassurance about the fiscal threat which (good news!) seems solved. We were, of course, and we bring you some masterpieces.

Yes, the pharmaceutical sub-sector within the world of events fascinates by its size, its specificities, and above all for a double threat: that the feared compliance code becomes more restrictive if can be, and that doctors should have to pay for the invitations to congresses that they receive from the pharmaceutical industry.

The event was attended by Mª Dolores del Pino y Pino (Spanish Society of Nephrology), Pablo Crespo (Director of the Legal Department of the Spanish Federation of Health Technology Companies, Fenin), José Zamarriego from Farmaindustria (association of pharma companies), Eduardo Ucar (rheumatologist, chairman of the local organizing committee of the National Congress of the Spanish Society of Rheumatology in 2003 and 2017) with the moderation of Jaume Boltà (vice president of OPC Spain) after an introduction by Matilde Almandoz (president of OPC Spain).

First key: transparency is already a reality, driven more by the industry than by the law, since the industry got tired of “having breakfast with scandal articles” and decided a few years ago to be absolutely exemplary and leave nothing frivolous to stain the image of the congresses. Mª Dolores del Pino and Pino stressed that in their congresses follow the regulations and codes of Fenin and Farmaindustria, explaining that “the key in this relationship is in the transparency and independence of health professionals.”

We saw two examples of codes in the pharmaceutical world. Pablo Crespo presented the new Code of Ethics for the Health Technology Sector, which comes into force on January 1, 2018 with a master idea: the financing of continuing education of doctors will now be channeled through health associations or organizations and there will be no direct invitations from companies to doctors. The other example is the Farmaindustria code. José Zamarriego highlighted its novelties. With two principles: prevention and transparency. And he recalled that the pharmaceutical industry is self-regulating, and publishes its own breaches when there are: “Which sectors can, when they make mistakes, say it with names and surnames?”

More or less every two years since 2004, Farmaindustria has changed its code, always going for more limitations of what can be done in congresses. The latest change is the need for laboratories to publish all “transfers of value” to doctors, with the famous “even if they give a pen they have to declare it”. “The concept ‘nothing’ is very clear,” said José Zamarriego, noting the great value of this code, which leaves no grey area. Verdict: The industry has financed the congresses market by about 193 million euros last year. Notably, unlike Fenin, members of Farmaindustria do invite physicians directly, and declare which doctors they have invited. They do not go through associations.

Second key: congresses are here to stay. Mª Dolores del Pino y Pino has no doubts: “we are not going to stop doing it”. Congresses will continue because they are for companies and laboratories, a vital point of contact with the needs of doctors and their patients. Pablo Crespo explained that “industry has traditionally ensured training and we are delighted to continue to do so and even further democratize training. Technology is in constant renewal and it is essential that there is continuous training of doctors. We could not develop new drugs without the doctors telling us what they need”, he added.

Another reason why congresses are necessary is that, unfortunately, doctors in Spain charge little and can not afford to pay for their continuing education. In fact this information can explain that the government has ruled out that doctors should pay taxes on invitations to congresses: this would have almost killed the essential continuing training. Eduardo Ucar sentenced in this regard that “the financier remains the pharmaceutical industry. And it will continue to be so. “

Third key: the scientific program is the absolute key. If there is no longer any ham (and we must say that the ham and the iPad have really disappeared from congresses), the hook for doctors to come is the content: José Zamarriego says that “the key is the scientific program , all the rest is secondary. Speaking with many societies, one realizes the strategic importance of content to get assistance. The code has led to an enormous improvement of the sector, putting all the focus on the quality of the scientific training.

Fourth key: Online will complete. It was not a much discussed subject, mainly addressed by Mª Dolores del Pino y Pino who explained that “we had many face-to-face meetings, we developed the information and content online, as a complement to the meetings. Our online sessions sometimes exceed 400 subscribers. ” But we are in a moment in which nobody doubts the survival of the congresses (in fact Jose Zamarriego remembered that the support of the industry to congress was on the rise) but the online training complements face-to-face quite clearly.

The happy ending: fiscal relief. Regarding the fiscal issue, José Zamarriego recalled that the royal decree that clarifies taxation is already in progress: the participation of doctors in congresses is exempt from taxation by the recipient.

Jaume Boltà closed with a positive message, estimating that these codes will force the sector “to make a reflection to look for the positive side of these changes, it may be an opportunity to make a joint thought for the future of the MICE sector.” You know, Darwin…

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