Market Access and Regulatory Creep

  [You can see Gerry's slide presentation here.]

Meeting Summary by Floree Thistle

On the topic of "Regulatory Creep," Gerry McDole likes to quote the old Pogo comic strip, "I have seen the enemy; and it is us!"

Gerry McDole

He says the Canadian pharmaceutical industry itself is responsible for much of the regulatory environment in which it struggles. In particular, he takes the industry to task for its response to the Common Drug Review (CDR).

"I've got to say, in fairness to the CDR, industry has not been responding very quickly to their demands; and we should be," said McDole. The former President and CEO of AstraZeneca and AstraPharma, Past President of the Canadian Foundation for Pharmacy, and former Chairman of the Board of Rx&D was speaking at the February 2nd kick-off meeting of the OPMA for 2009.

McDole explained that the CDR, which has the mandate to conduct objective, rigorous reviews of clinical effectiveness and cost effectiveness of drugs, was originally intended to eliminate individual provincial reviews. "Now, you could argue that we are playing catch-up, that they sprung this on us and we didn't have time to get our studies documented to give them the information they're looking for. But by and large we've done a pretty damn poor job," he said.

Among its shortcomings, the industry doesn't always provide the comparison to the gold standard, it doesn't provide budget impact analysis, and it doesn't provide good cost effective data. "All I'm saying is that we should start doing this at the front end, not at the back end. And if it was part of your original file, part of your product monograph, and part of the regulatory approval process, you'd go a long way to solving some of these problems; and you might even slip by the CDR a little more often!"

McDole has been in the industry for many years, and with so much experience, he has been involved in reshaping the industry but also living through changes—both good and bad. His talk provided insights from his wealth of experience and food for thought for those working in the pharmaceutical industry today.

At the beginning of his talk, McDole outlined three important beliefs that he said would "bias" everything he had to say:

1. Regulators rarely lead, they follow. Regulators react to events, business activities, and corporate behaviours that aggravate the public—and they create rules to control this activity.
2. Once these regulations are in place, it's hard to change them. Industry is better off putting its energy into dealing with the regulations than trying to change them.
3. Canada is a semi-socialist country with a culture that loves to hate big business, especially when it makes money—and that includes big pharma. He held up a newspaper clipping with the headline, ‘Health plan funds killer drug’ which he said represents a typical attitude of painting big pharma in a negative light.

McDole warned that we will be getting more legislation, particularly in the form of the ‘progressive licensing initiative.’ What can we do to prepare for it, since ‘the train has already left the station’?

1. Prepare a quality file.
2. Meet unique Canadian requirements.
3. Provide a risk management plan.

To finish his talk, McDole presented his wish list as to how people in the Canadian pharma industry will face the future:

1. Ask yourself, "How will regulators react to what I will do?" If you think you can get away with it, then do it. But if the activity is questionable then have the strength not to do it.
2. Be proactive; get into the field and speak to customers, get to know about things that will blow up in your face.
3. Network and support other healthcare providers year round, not just when you need their support. Work with stakeholders all the time, not just when you need them. We need to change the perception of the public that big pharma is bad.
4. Don’t leave it to Rx&D. Each and every member of the pharma marketing community has a responsibility to change the environment and the value systems of how we do business, and to encourage economic growth and development.

He left those gathered at the meeting with one last thought: "Management is the art of doing things right. Leadership is the art of doing the right thing. Choose leadership and do the right thing!"

About the Author:

Floree Thistle is the Principal of Thistle Research Consulting. She can be reached at floree@thistleresearch.com, or (905) 709-1176 .