Primero fué SANDOZ, ahora ROCHE: Los suizos estan "salidos"... de los organismos gremiales internacionales.

Primero fué Daniel Vasella el que dió el "portazo" y dejó a SANDOZ fuera de la IFPMA. No los gustaban los controles que imponía la Asociación que, según su entender, "limitaban" la operatividad de esa compañía "bipolar"

"Sandoz is no longer a member of IFPMA and does not have to comply with its obligations."
dijeron.

Ahora es ROCHE... En el 2008 la ABPI le sacó "tarjeta roja" y fué suspendida "su militancia" por las malas prácticas con XENICAL.

Seis meses después, transcurrido el tiempo "pertinente", autorizaron su regreso.

Ahora dicen que no les interesa, que seguiran fuera:

30 June 2009
In a shock move Swiss drugmaker Roche has decided not to renew its membership of the Association of the British Pharmaceutical Industry, putting a question mark over the viability of self-regulation in the UK.

In the UK, the Medicines and Healthcare products Regulatory Agency possesses the legal power to take pharmaceutical groups to court for any wrongdoing, but generally it is the ABPI’s Precription Medicines Code of Practice Authority that deals out penalties to its member companies for bad behaviour.

Roche has been on the receiving end of ABPI sanctions before, after its membership was suspended for six months until February this year in connection with “serious breaches” of the Association’s Code of Practice, relating to the inappropriate sale of large quantities of its weight-loss drug Xenical (orlistat) to an operator of private diet clinics.

Now the company says that its time away from the ABPI gave it the opportunity to “reflect upon the nature” of its relationship with the trade body and consider mutual needs in the future. “We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being [but] will continue to review this situation,” the group said in an e-mailed statement to PharmaTimes UK News.


Más...

Pero la decisión no se limita al abandono de la ABPI sino que tambien consideran cancelar su adhesión a la Pharmaceutical Research and Manufacturers Association (PhRMA):
Hoffman La Roche is severing its ties to Big Pharma.

The venerable drug maker this week plans to drop its membership in the Pharmaceutical Research and Manufacturers Association.

PhRMA, as it is known informally, is the leading trade group for the U.S. pharmaceutical industry.

Más...

En resumen..."no me dejan jugar como quiero...rompo la baraja"

ROCHE: Volver, volver, volver a la ABPI

Hace seis meses fué publicamos fué sancionado en UK. Transcurrido el
tiempo "pertinente" permiten su regreso.

Roche Products Limited has been reinstated to membership of the Association of the British Pharmaceutical Industry (ABPI) following the company’s suspension from 14 July 2008. The ABPI Board of Management decided that Roche should be reinstated to membership with effect from February 16, but that the ABPI Board would review the report of a further audit to be held in November 2009 to ensure that progress was being maintained.
Roche was suspended from membership for a minimum of six months after it was found to be in breach of the Code, including Clause 2 which deals with activities that bring discredit on, or reduce confidence in, the pharmaceutical industry. ABPI Press Release, Monday 14 July 2008.

Humor...es lunes: De_Roche...de vodka./El congreso se divierte.

The conduct of senior Roche employees has come under the spotlight following a complaint about drunkenness and poor behaviour at an overseas medical conference last year. 

 An anonymous and uncontactable complainant to the PMCPA claimed that: “Vodka shots and shots of varying colours flowed like hot lava, unstoppably.” 

 The Roche staff were alleged to have been dispensing this hospitality to doctors at the conference during a ‘raucous’ late-night drinking session at a bar. 

 The complainant said one senior Roche employee jumped onto the stage in a drunken state and ‘made a buffoon of himself’ being physically evicted from the bar by bouncers. 

 The PMCPA said the manufacturer was in breach of clause 9.1 of the ABPI Code of Practice, which states that “high standards must be maintained at all times”. (Más)

Ver también:
PMCPA_AUTH/2509/6/12 - Anonymous v Roche

FARMAINDUSTRIA: "Transferencias de valor" nuevo eufemismo por... ¿Cuánto pagan las farmacéuticas a los médicos?

Novartis lidera el ránking con un desembolso por valor de 37,4 millones de euros en 2015. Ferrer es la primera empresa española con pagos de 20,7 millones de euros. 

Las grandes farmacéuticas realizaron pagos por un importe superior a los 300 millones de euros a profesionales y organizaciones sanitarias españoles el año pasado. Las compañías adscritas a la patronal Farmaindustria asumieron el compromiso de desvelar los datos de transferencias de valor destinadas básicamente a profesionales, organizaciones sanitarias e investigación y desarrollo. 

Entre los pagos, dados a conocer por primera vez ayer, que se publicaran cada junio, figuran donaciones, la colaboración en actividades formativas, reuniones científico-profesionales, prestación de servicios profesionales (asesoramientos y ponencias) e I+D. Este último dato corresponde a la aportaciones a organizaciones para realizar I+D y que es sólo una parte del gasto que las farmacéuticas destinan a investigación dentro de su estructura. 

El Código de Buenas Prácticas de Farmaindustria obliga a sus socios a publicar el dato desde este año. Las firmas que lo incumplan se enfrentarán a una multa de hasta 360.000 euros y a su expulsión de la organización.

Ver:

Farmaindustria pone barreras a la corrupción.

Novartis es la farmacéutica que lidera esta transferencia de valor, con 37,4 millones de euros, seguida de Roche, con 31,7 millones, y Pfizer, con 30 millones. La compañía española que más dinero pagó al sector sanitario fue Ferrer, con 20,76 millones. 

El principal gasto es el que se refiere a I+D. La partida no recoge toda la inversión en este campo de los grupos, sino sólo el coste de los ensayos y estudios clínicos que se realizaron en territorio español. Las grandes compañías farmacéuticas invirtieron 143 millones en este concepto. 

Novartis fue la compañía que más destinó a este apartado, con 20,2 millones de euros, una transferencia de valor que forma parte de su inversión en I+D total en España que ronda los 100 millones. Es la farmacéutica que puso un mayor número de medicamentos nuevos (sin incluir los genéricos) a disposición de los pacientes en los dos últimos años: 20 nuevas especialidades médicas en forma farmacéutica, principio activo o nueva indicación. Sólo en 2015, puso en marcha 200 ensayos clínicos en España en los que participaron 942 investigadores en 400 centros sanitarios. En el caso de GSK, la I+D supone el 55,6% de su transferencia de valor total. 

Por su parte, la empresa española que más invirtió en este capítulo fue Ferrer, con 16,5 millones de euros. También destaca la inversión que realizó Esteve, con 13,6 millones de euros. Almirall y Grifols tienen sus inversiones en ensayos clínicos más repartidos por el mundo. 

Profesionales 

La segunda mayor transferencia de valor corresponde a los profesionales sanitarios, a través de prestaciones de servicios, asesoramiento, ponencias, congresos y desplazamientos, con 94 millones. 

 La compañía que invirtió fondos en este aspecto fue Pfizer, con una partida de 15,9 millones de euros. A continuación, Novartis (10,9 millones), y MSD (10,43). La farmacéutica americana destino a formación de profesionales 5,5 millones y otros 4,8 millones a honorarios por servicios profesionales en base a su valor justo de mercado. 

Roche, colaboró con 3.397 profesionales y 266 organizaciones recibieron transferencias de valor, destinó 4,6 millones a la formación. GSK, por su parte, aportó 4,37 millones de euros. Las actividades formativas y reuniones científico-profesionales representan el 19% de su transferencia de valor. Trabajó con 4.612 profesionales sanitarios y 242 organizaciones sanitarias en 2015, según el grupo británico, que destaca que más del 95% de las colaboraciones realizadas por profesionales sanitarios se publica en su página web de forma individualizada. El importe destinado a formación supuso, de promedio, 366 por cada profesional sanitario. 

La tercera partida principal de la transferencia es la que se refiere a las organizaciones sanitarias. Las grandes farmacéuticas pagaron en donaciones, asesoría y formaciones a estos organismos 63 millones de euros. La primera compañía de esta lista es MSD, con 7,75 millones de euros, seguido de la suiza Roche, con 6,8 millones. A nivel español, el primer puesto recae en Almirall, con 1,5 millones. (Ver)

Y también en U.K.

Pharma spent £340m on healthcare partnerships in 2015

The pharmaceutical industry dished out £340.3 million last year to healthcare professionals and organisations, a new payment disclosure database has revealed. 

 The Association of the British Pharmaceutical Industry (ABPI) has now published, for the first time, details of payments or benefits in kind made to doctors, nurses and pharmacists, as well as other health professionals and organisations in the UK, on a publicly accessible database called Disclosure UK.

IFPMA: Prohibidos todos los regalos/Sin excepción

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January 14, 2019 
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has published its new code of practice, introducing a total ban on gifts and promotional items for prescription drugs for the first time.

The 2019 code says the ban on gifts or ‘goodies’ now applies wherever its member companies operate, a big departure from earlier versions which included exceptions “based on the custom of gifts to mark significant national, cultural or religious events.”

In practice, that allowed multinational drugmakers to continue to give gifts in countries where there is an established custom of gift-giving, such as China and Korea.

In China for example the traditional exchange of pastries – called ‘mooncakes’ – for the country’s annual Mid-Autumn Festival will now be forbidden for people working in pharma companies. A box of the pastries can range in price from $30 to $1,000 or more for luxury brands, and there have even been examples of mooncakes being given that were made of gold and silver, according to a Bloomberg Law report. 

Also banned now are condolence payments – envelopes of money sent to express condolences for the death of a loved one – which are a common practice in Asian countries.

The code does indicate that promotional aids of “minimal value and quantity” can be provided to healthcare professionals for the promotion of over-the-counter (OTC) products – provided they are relevant to their practice.

IFPMA’s code first appeared in 1981 and was most recently revised in 2012, when its scope was expanded beyond marketing practices to cover all interactions with healthcare professionals, medical institutions and patient organisations, and a ban on gifts that would be of ‘personal benefit’ introduced. 

Ver:
 Todo sobre IFPMA Code en PHARMACOSERÍAS

Many of the big pharma companies – including Novartis, AstraZeneca, Roche, Astellas, Pfizer and Takeda – unilaterally adopted a ban on gift-giving in all the territories in which they operate last year, recognising that the change in the IFPMA code was due to come into effect on 1 January 2019.

The removal of the exception for customary gifts “reflects [the] pharma industry’s commitment towards the general concern that the promotional items trivialise the important, professional relationship that must exist between medical representatives and healthcare professionals, and that has the patient’s interests at its core,” said IFPMA.

The update to the code comes after some high-profile incidents in which pharma multinationals have been linked to the payment of kickbacks to doctors and government officials in emerging economies. 

Ver:
Todo sobre kickbacks en PHARMACOSERÍAS

A few years ago, GlaxoSmithKline was fined around $490 million by the Chinese authorities for paying bribes to boost sales, with some kickbacks paid in the form of gifts, and also had to pay $20 million to the US Securities and Exchange Commission (SEC) for contravening the Foreign Corrupt Practices Act (FCPA).

Ver:

2001 "A GSK China Odyssey..." / El inicio de la "saga_cidad".

Last September, Sanofi paid £25 million to settle charges that its subsidiaries made bribery payments to win business between 2007 and 2015 in Kazakhstan and certain Middle East countries, while Teva admitted it bribed officials in Russia, Ukraine and Mexico in a 2016 case and Bristol-Myers Squibb (BMS) was fined $14 million for bribery in China in the previous year.

“Implementing the new and revised code in full is about walking the talk, about earning our license to operate,” said Thomas Cueni, IFPMA director-general.

“We encourage doctors, pharmacists, nurses and patients to become aware of the updated ethical standards. The better our stakeholders understand our standards and hold us to account, the easier it will be for us to live-up to our commitments.”

The UK ABPI’s code of practice introduced a ban on direct gifts and inducements in 2010, and since then has been tightened up even further to include additional measures such as making sure pens and pads provided in conference bags at third-party organised events must not include the names of the donor companies, the name of any medicine or any information about medicines. (Ver)

The top 10 pharma R&D budgets in 2016

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Last year, biopharma won its share of new drug approvals, though not as many as we're used to in the U.S., as research spending came to fruition. But drugmakers also suffered a number of R&D setbacks, cut research staff, rejigged their operations and refocused their pipelines. 

Drug R&D also found itself in the spotlight as one of the biggest political issues to arise last year—drug pricing—became inextricably linked to the cost of biomedical research and development. U.S. industry groups PhRMA and BIO, as well as Europe’s EFPIA and the U.K.’s ABPI, have all said, and will continue to say, that the inherent reason drug prices are what they are is because of the huge R&D investment most (though not all) companies funnel into their scientists and labs. 

 It’s a risky business: The majority of drugs that begin phase 1 won’t be approved, and over the years, failures in phase 3 have cost individual companies hundreds of millions of dollars each time. Sometimes failures stem from problems with the studies themselves, sometimes a company simply refuses to give up on a dead asset, but often, a failure in the lab is simply part and parcel of the trial-and-error approach inherent to pharmaceutical and biotech research. 

Based on figures from their 2016 annual reports, the top 10 pharma R&D budgets (all using their GAAP figures) combined totted up to $70.5 billion, with full-year revenue coming in at $404.8 billion. (Más)

Roche
R&D budget (pharmaceuticals and diagnostics): CHF 11.53 billion ($11.42 billion) 
Change from 2015: Up 20% 
Total 2016 revenue: CHF 50.57 billion 
R&D budget as percentage of revenue: 22.8% 

J&J
R&D budget (also includes device and consumer healthcare work): $9.09 billion ($7 billion for pharmaceuticals) 
Change from 2015: Up 0.5% 
Total 2016 revenue: $71.9 billion 
R&D budget as percentage of revenue: 12.6% (10% for pharmaceuticals) 

Novartis
R&D budget: $9 billion 
Change from 2015: Up 0.8% 
Total 2016 revenue: $48.5 billion 
R&D budget as percentage of revenue: 18.5% 

Pfizer
R&D budget: $7.87 billion 
Change from 2015: Up 3% 
Total 2016 revenue: $52.82 billion 
R&D budget as percentage of revenue: 14.8% 

Merck
R&D budget: $7.19 billion 
Change from 2015: Up 7.3% 
Total 2016 revenue: $39.8 billion 
R&D budget as percentage of revenue: 18%