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Healthy Skepticism Library item: 18927

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Electronic Source

Silverman E
European Pharma Worries About Compliance Rules
Pharmalot 2010 Nov 18
http://www.pharmalot.com/2010/11/european-pharma-worries-about-compliance-rules/


Full text:

In this world of fraud, bribes and huge fines, what do companies doing business in Europe anticipate when they hear the word compliance? In short, lots of change. A new survey finds 93 percent believe regulatory compliance will be a big challenge and 82 percent say new regulations – such as the US Foreign Corrupt Practices Act and the UK Anti-Bribery law, which becomes effective next April – are going to have a measurable impact.
More specifically, 62 percent say that implementing transparency guidelines will prompt decreases in promotional spending. And 53 percent expect to spend more on transparency efforts to increase. The survey, by the way, was conducted by Cegedim, a consulting and market research firm, which queried 117 people – 83 percent from drugmakers; 8 percent from device companies and 6 percent from biotechs (88 percent are involved in marketing and promotional activities and oversight).
There may, however, be a silver lining percent that implementation transparency guidelines will actually lead to better ways of allocating resources. And 75 percent believe that current methods of tracking promotional spending in the US will eventually be used in Europe as well; in fact, 47 percent say such a change will probably take place and only 10 percent are adamant this will not occur.
Nonetheless, most are optimistic they can handle whatever comes their way – 31 percent say their company is excellently positioned to comply with transparency regs, and 42 percent are confident they are well equipped. Twenty-two percent believe they are fairly equipped, and only 3 percent worry they are poorly equipped to cope. By comparison, just 29 percent of US companies believe they are in very good shape (maybe more US execs are worried about individual accountability?)
“This clearly reflects the different levels of maturity in the US and the very strong culture of enforcement,” Cegedim concludes. “In the US, organizations have to demonstrate regulatory compliance to what are far more stringent regulations that span the entire organization, not just the sales and marketing role. While in Europe, there are, as yet, no best practice guidelines or benchmarks for regulatory compliance activity.”
When it comes to complying the FCPA and UK’s Anti-Bribery Law, the biggest concern is collecting all relevant spending data at 39 percent, while data integrity and identifying spending recipients is next biggest worry at 36 percent each. Preparing reports for data disclosure was cited 34 of the time. Obviously, there are multiple concerns, which is why this adds up to more than 100 percent.
Interestingly, in the US, just 37 say their company enforces corporate standards for healthcare professional and capturing spending data that applies to suppliers and staff. The others either do not have standards or have standards which are not used universally. But in Europe, here the market is significantly less regulated, 83 percent enforce corporate standards.

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.