The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice aims to ensure that pharmaceutical industry practices are governed by ethical standards, as well as remaining in line with societal expectations.

The code was first drawn up in 1981 and has been revised five times since, most recently in 2012, with each revision reflecting changes to the external environment, rules and regulations change, and societal expectations.

Eli Lilly chief ethics and compliance officer Melissa Barnes led the development of the 2019 edition, which features amendments with two main focuses. The first is the introduction of a ban on gifts and promotional aids for prescription-based medicines, and the second is the inclusion of an IFPMA ethos.

At the recent IFPMA event for global stakeholders in Geneva, Barnes discussed the revision process and the significance of the new Code for the industry.

Berenice Baker: How are people invited to work on revising the IFPMA Code of Practice?

Melissa Barnes: What is now known as the Ethics and Business Integrity Committee is a group of ethics and compliance experts within our industry. They represent the membership at IFPMA—so companies such as Eli Lilly—and I chair that group.

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Companies appoint someone that is in a senior-enough position to speak with some level of authority because we make decisions in those rooms; two long years of work went into the revised code that comes in effect in January.

Associations from around the world are also represented, and they again send subject-matter experts who can contribute and make the decisions that need to be made in this work.

BB: What is the process for making revisions?

MB: We have a charter and hold committee meetings regularly to talk about what needs to be done. In addition to the Code of Practice, we also opine on other issues and do notes for guidance and other helpful publications.

We work in a grey space. There are certain things that are black and white, and others where, frankly, it’s often a matter of interpretation where we should go, so we try to publish the kinds of information and have the kinds of conversations to meet those needs along the way.

BB: Tell me about the first major amendment in this edition, the global ban on gifts and promotional aids prescription medicines.

MB: It brings into alignment globally what had already been in place in major markets in the world, Europe and the US in particular. It is a recognition of societal changes and expectations, and the importance of the relationship between the patient and the healthcare professional, and the relationship between the healthcare and the medical representatives.

That relationship is intended to be an exchange of our expertise and to share information about medicines that may or may not be appropriate for their patients, and that is for those physicians to decide. The idea that anything would get between the physician and the patient at the point of decision is unacceptable.

BB: The second focus is the introduction of the IFMPA ethos. What impact will that have?

MB: The Code is a unified set of values that we can apply in the grey spaces when people are making decisions. If you take a copy of the Code, the ethos is not at the beginning or the end; it’s physically at the heart of it. It’s a recognition of how we need to conduct our business from beginning to end—from research and discovery to making and distribution—to ensure that our patients are safe post-prescription.

The ethos provides a backdrop to support those decisions companies and associations make daily. It’s intended to be our lighthouse or our guide to ensure that we as a collective industry—our association members and our industry member—can use that to help guide our decisions along the way. That’s a big change for the IFPMA and for this Code of Practice.

Up until just over a couple of years ago, the committee was called the Code Compliance Network. When I took my role at Lilly almost six years ago, I said I can’t be a chief compliance officer, but I can be a chief ethics and compliance officer. In keeping with this, the name of the group that revises this code is now called the Ethics and Business Integrity Committee because if you shoot for compliance, you might just get compliance and you don’t necessarily get ethics and integrity. However, if you shoot for integrity, you very naturally get compliance.

BB: How is the code enforced?

MB: Many of the associations that are members of IFPMA also have local codes, and they have enforcement authority, and generally that’s where code enforcement takes place. However, for those companies that are not members of those national associations, and sometimes there’s no national association in a country, that’s where the IFPMA steps in. It’s a self-regulated structure.

BB: What’s next for the IFMPA Code?

Remember that we’re dealing with human beings, so it’s important that we don’t just publish a code then walk away from it. So implementing it goes well beyond just publishing it. We deliver publications and training, as well as monitoring to find those areas where we could be more clear or more helpful.

BB: What has the reception been like?

MB: It’s generally positive. We have aligned interests with the stakeholders we’re dealing with;  it’s to do with what’s right for the patient, and if that’s your North Star, you’ll get it right 99.9% of the time.

Frankly, that’s how you get to the right answer, debating what’s the right approach. It has to work locally, it has to work within a culture, and the folks in that locale know that best. We can’t drop in and teach them. There’s no cookie cutter or silver bullet that works across the board. There’s a framework, and once you get that in place and the right people involved, it naturally takes a positive turn.

BB: What is your message to the pharmaceutical industry about the Code?

MB: We take it very seriously. There is a lot of dedicated time, effort and resources that go into this work. I think it’s important work, particularly for our industry where trust is at the centre; we have wonderful pipelines of medicines that we hope to bring patients that are waiting, but if we bring those medicines to the marketplace and the marketplace doesn’t trust us and what we say about those medicines, then it does no-one any good.

I’ve been in the pharmaceutical industry for 25 years, and I wouldn’t be here if I didn’t think our mission wasn’t noble.