May 27, 2009
Just a regulatory guy
On May 27, PMCQ was pleased to host Ray Chepesiuk, PAAB’s amiable commissioner as the Club’s final speaker for the 2008-2009 season.
Mr. Chepesiuk, true to his generous and garrulous personality, presented a wide-ranging overview of the pharmaceutical marketing regulatory environment as it now stands, the influences from south of the border and the pressures from various quarters on Health Canada to beef up its controls in ways that might not suit PAAB or its clients.
In presenting Ray Chepesiuk to a packed dinner crowd, Dan Leger of Lundbeck Canada spoke about the commissioner’s past as a Canadian peacekeeper – an allusion Ray picked up on in claiming that some people think that’s his pre-eminent quality to be PAAB’s chief.
“I’ve been commissioner 10 years now and I look back and think my first year was the easiest. Often it’s the other way around, the first year is rough. But times have changed. Society has changed. Regulatory has changed and PAAB has changed.”
With that he segued into the indisputable fact that times are tough for the industry. “I talked to a lot of strangers on a cruise recently and I must say they weren’t too flattering about the pharmaceutical industry.” In his eyes, though, it’s part of PAAB’s role to help pharmaceutical marketers weather that storm.
Part of that task is streamlining and updating PAAB itself. Last November the organisation finally adopted its very first vision and mission statement.
The vision is “Trusted healthcare product communication that promotes optimal health.” The mission statement is “To provide a pre-clearance review that fosters trustworthy healthcare communications within the regulatory framework.” Finally, PAAB’s values are integrity, competency, credibility, independence, excellence and transparency.
He then talked of PAAB’s mandate stressing both the independence of the agency whose role is to ensure that healthcare product communication for prescription, non-prescription, biological and natural health products is accurate, balanced and evidence-based. In order to do that effectively and to ensure current best practices are respected, PAAB has hired more staff. There are 15 people working in the organization now, with 8 reviewers to make sure PAAB can keep its 10-day turn around promise.
Despite the recession and the difficulties of the industry, the last three months of ’08 saw a record quarter in terms of volume.
To keep up with shifts in how products are marketed and the volume of new products coming online, PAAB will be publishing a new code shortly. In the meantime Ray Chepesiuk was proud of both PAAB and its clients that complaints are down a lot, indicating that people do want a self-regulatory environment.
Yet all is not rosy. The DTC environment presents challenges all its own and Chepesiuk warned that if people aren’t careful, Health Canada will intervene aggressively in drafting restrictive policies. Of particular note, PAAB has set aside $50k for solid advertising/marketing research projects and urged PMCQ members to forward names of people doing such research to him so he can connect them with the PAAB committee.
He then painted a dark picture of how scandals and some problematic situations arising out of DTC advertising in the US have changed the environment there, to the extent that 28 states have now got into policing pharma, in addition to the Federal government and the FDA. Some of the changes have reshaped how US companies develop their internal policies, which sometimes have unintended consequences for global marketing campaigns. PAAB is always willing to remind companies that the Canadian environment has its own rules and regulations.
In that regard he touched on branding and CME’s reminding everyone to be very careful. “If you link branded and unbranded, it’s all branded. Keep CME in CME and advertising in advertising.”
In terms of DTC, while broadcasters, especially CanWest Global, would like to see a looser environment, others, especially politicians on Parliament Hill, are musing about going the European route where there is no DTC at all. A Harris Poll in the US, he said, saw people’s trust in the industry float around 28%. “According to someone at Rx & D it’s closer to 45 or 46% in Canada.” He attributed the decline in trust to unfortunate mistakes and abuses south of the border and warned people to “stay on message.”
This is especially true with new viral media, where US practices can’t simply be imported.
Speaking generally he asked: “Will there be self-regulation? It’s up to you, we need your support. We’re an advisory body. PAAB’s role, we’re a referee, rather than the police. We don’t need more Health Canada regulation.” Of course with minority governments, it’s anyone’s guess as to what will happen in the fall.
Breakfast: 7:00 am
Presentation: 7:30 pm