Ensuring Global Compliance

Ensuring compliance on a global scale can be a daunting prospect. Robert Garnick of Genentech talked to NGP about his company’s approach to meeting this challenge.

Genentech has been a pioneering Biotechnology company with a long list of approved products, both in the US and overseas. But no matter how exciting a company’s projects are, there is always the issue of compliance lurking in the background. And when companies operate on an international level, compliance becomes even more challenging.

Although Genentech is primarily US-based, the company still needs to ensure its products are compliant on a global scale. As Robert Garnick, Senior Vice President of Regulatory Quality and Compliance, explains: “We have primarily a US focus, but we do have numerous partners outside the US, including Roche, Novartis and Serrano. We let them deal with the appropriate European regulations, but we still need to ensure the products we produce are completely consistent with current global regulations.”

This is achieved by developing a compliance culture throughout the company’s manufacturing, quality and support organizations. The basic principle is to ensure complete awareness of all global regulations. “We’re a development company and our main goal is to develop and market new biotech products for unmet medical needs. As a result, we’re often at the forefront of legislation. We aim to be a scientific leader in the industry, thinking through the ramifications of various pieces of legislation and getting involved in developing them. In this way, we’re able to help the FDA develop regulations and guidances that work for everyone.”

Genentech put a lot of effort into the success of the International Conference on Harmonisation (ICH) process with the European and Japanese regulators, and strove to achieve the same close working relationship with them as it has with the FDA. “We’re very involved in global regulatory development, both in the US, and in Europe through our partners at Roche and Novartis. We stay closely involved with developing regulations, and as they are completed and made into law, we make sure that we have very strong compliance. Our approach is to put the science up front and let it talk, and base our rules and regulations on what’s good science, not on political science.”

Genentech’s focus compliance group makes sure the company concentrates on all of the appropriate regulations and is in compliance with them. “We spend a lot of time and effort and people and money on, not so much bird-dogging things, but making sure our folks understand the regulations and that they have done everything they can to be compliant with them. We have a lot of internal and external audits; it’s quite a business.”

If there’s a specific new regulation that needs to be complied with, this is incorporated into standard operating procedures. The company then trains its manufacturing and quality organization on those new regulations, and implements them in the appropriate time frame. There is an internal and external auditing process in place that evaluates how compliant the company is with those regulations, and that information is reported to the Board of Directors on a regular basis.

While some companies may find preparing for and addressing regulatory change a challenge, at Genentech this is not the case. “I don’t think we find regulatory change that much of a challenge,” Garnick says. “We have the opportunity to explain the rationale to the internal folks here and to make sure our compliance group has done everything they need. It’s more of a standard operating procedure.”

The cost of compliance can be high, but so can the cost of noncompliance. “There have been companies receiving fines as large as $500 million. That’s so outlandish that no amount of money we can spend on compliance would offset it. Of course there’s a cost to compliance, but the cost of noncompliance can be infinitely higher. We do track it, we do pay attention to it, but we wouldn’t be making a business decision to not be compliant because compliance costs too much.”

Robert Garnick is SVP of Regulatory Quality and Compliance at Genentech. He has worked in the pharmaceutical industry for 31 years, and is currently leading the effort to develop a long-acting form of treatment for wet AMD.