The US Sunshine Act and its equivalents

It has been raining for weeks. The plants on my balcony are divided in their enthusiasm. My fern, bleeding heart and shiso plants are happy, while the chiles, the sage plants, the basil plant and many others have not grown since the rains started, reminding me that plants like humans need the right conditions in which to thrive.  

In the past weeks I have worked on regulations that apply for engaging with customers in various markets, started reading a book on the gender data gap, and joined a Balint group that runs at 3am my time (7pm in Boston). Today’s newsletter draws from these experiences.

Today’s topics:

  • The US Sunshine Act and its equivalents
  • Do you speak my language?
  • Address bias to improve business
  • Leadership: Words, words, words

The US Sunshine Act and its equivalents
 
The U.S. Physician Payments Sunshine Act, which is part of the Affordable Care Act, went into effect on August 1st, 2013, with the aim make the financial relationship between healthcare professionals and healthcare organisations and drug, device and biological product manufacturers more transparent. Manufacturers track and report payments or transfers of value provided to healthcare providers.
 
Payments and transfers of value may include payments for speaking engagements, research activities, continued medical education and travel or physical items such as gifts or the provision of scientific literature, training materials etc.
 
The data reported by manufacturers is published annually on the US government’s open payments website and can be accessed by any interested party Link. The threshold for reporting of a payment or transfer of value in the US is 10 USD and failure to report accurately can result in heavy fines.
 
Many US companies expanding outside the US market are curious about the regulations governing pharmaceutical industry practice including transfers of value in other markets.
 
The situation outside the US is not uniform, while some countries have implemented a standalone Sunshine Act equivalent approach with a tracking platform, such as Belgium (Link), many other countries have instead integrated guidance on transfers of value between the pharmaceutical industry and physicians into their regulatory framework for medicinal products.
 
For markets where no specific legal framework exists for payments and transfers of value, such as Vietnam, Malaysia or the Philippines, the Codes of Practice of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and their Member £Associations provide important guidance (Link), which is helpful whether or not a company is a member of these associations.   
 
This short introduction to the topic highlights that there is a large degree of variation between markets and that it is important to note that both regulations and codes are specific to each market and can vary substantially.  If you are curious to know more please contact me. 
 
Key take-away:  
The world is complex, it is worth preparing before you venture out.

Do you speak my language?

Have you ever wondered about the language constraints the pharmaceutical industry operates under? Wondered what guidance or expectations regulators have for pharmaceutical companies operating in individual markets?

Have you worried about engaging French customers in French, providing Iranian customers with Farsi speaking Medical Science Liaisons, or thought about the budget implications involved in trying to provide each market with native-speaking health care professionals to answer questions on your medicines and devices?

If so, you are not alone. The decision regarding the language you use depends in part on the market you are in, and naturally on local regulations and local culture, but also on the size of your local operation, your current future portfolio and many other considerations. If this is an issue you struggle with let me know.

Key take-away: If you worry about language, you are not alone, but it is less complicated than you might think.

Address bias to improve business

At last months BOOM summit in Basel, I spoke with participant and entrepreneur Douglas Drake about AI, data analytics and biased data amongst other topics.

Douglas recommended I read the book “Invisible women – exposing data bias in a world designed for men” by Carole Criado Perez. I am only in the middle of the book; however, it is fascinating reading so far.

Some of the examples have stayed with me: prehistoric cave art was historically attributed to men, because men hunted, recent research highlights that this attribution was likely erroneous. For many, female warriors were unthinkable. Hence when a skeleton with a female pelvis was found buried with two war-horses in 1878 it was considered male until a recent DNA analysis in 2017 showed that the skeleton was in fact female “Guided by comprehensive genomic sequencing, archaeologists first revealed the unexpected findings of the woman warrior in a 2017 study published in the American Journal of Physical Anthropology. But as Live Science’s Laura Geggel explains, naysayers immediately unleashed a storm of criticism, alternately questioning whether the researchers had analysed the correct set of bones, overlooked the presence of a male warrior sharing the grave, or failed to consider if the grave actually belonged to a transgender man” Smithsonianmag.org.

While you might say this is irrelevant and that the gender of an ancient Viking warrior is not important, it does illustrate that when something is unthinkable it is changed to fit the acceptable narrative. When I examined a patient as a medical student she assumed I was a nurse. The German word for doctor is masculine. Most doctors at the time my patient was young were male and so her world view was that a doctor is male and a nurse is female. I was female consequently a nurse.

Over the ages, assumptions and societal norms have coloured the interpretation of data from many different research fields. Unless corrected this robs us of the image of the world as it is, and this in turn robs us of the ability to design solutions and products for the world as it is, to build businesses that serve today’s populations and in fact to develop new markets. Yet, revenue generation depends on discovering new target audiences.

And new target audiences are being discovered as witnessed by the pharmaceutical industry’s recent discovery of women’s health topics, and the ubiquitous newly emerged enthusiasm for women’s health and pledges to invest in research and rectify the wrongs of non-inclusive research past.

I receive many variations of the following message on a daily basis “AI will revolutionise healthcare, medicine development, drug dosing etc. etc.”

I am not saying that AI cannot do this. I am sure it can, but the tool is not the problem. The potential problem is that AI is trained on data, that represents the world as it was, with biases and flaws. To design solutions that are fit for purpose we need a significant amount of knowledge and awareness to unpick bias/missing attributes in the data. And sometimes the data just does not carry the information that is needed to address the task at hand. For an excellent example of this read about snow plough deployment in Sweden and why non-gendered commuter data is a perhaps surprising issue in this context: Link.

Key take-away: Question your training data, ensure you have broad population representation when questioning the data, and designing solutions to ensure you don’t miss something. And: if you do not do it for the people, then do it to improve your business outcomes.

Leadership: Words, words, words

I trained as an executive coach at the Tavistock Institute in 2019. Since then, I have participated in Group Relations Conferences which have a fascinating mind-expanding effect. I highly recommend you participate in one if you want to increase your self-awareness and understand how you follow and lead. I have also trained in various techniques such as using constellations in my coaching work.

The work I do in collaboration with others ranges from coaching executives and teams, often when the pressure is intense, to supporting global transformation efforts, to work around data, analytics and systems, to finally supporting medical affairs and medical information strategy and operations. It is broad and it is beautiful. I enjoy the breadth of what I do and I am always learning.

So, when a month ago I was asked if I’d like to apply to participate in a Balint-oriented consultation group by one of the facilitators, who is a friend of mine, which is being organised by the Center for the Study of Groups and Social Systems, the Boston Affiliate of the A.K.Rice Institute, I was excited.

I naturally said yes, despite the fact that the group meets for two hours every month at 3am my time. I am a night person but not an early morning person. Three am, is, I believe, a non-time. However, I signed up, and when I joined the first meeting, it was worth every minute.

The focus of the group: to provide confidential peer feedback on dilemmas of functioning in organisational role. Initially I remember the participants were asked by the facilitators to share a “case”, or a “problem”. No cases, or problems were forthcoming. There was silence.

However, then a facilitator said “How about, a dilemma? Anyone, have a dilemma they want to share. It may not be a problem?” Suddenly we had presenters.

This continues to fascinate me because it illustrates the power of the right words to unlock access to content. This is relevant both for people working across language barriers and cultures, because a word that resonates with you, may not resonate with those who speak another mother tongue, but also for anyone engaging with others in conversation.

If a question you ask doesn’t elicit a response, try a synonym. Beyond testing different words, it is important to be able to wait until a response surfaces.

Key take-away: when looking to understand and communicate with others, be aware of how you use language.

I hope my posts provide you with useful insights. If  you need support with a project, or are interested in coaching, why not give me a call to see how I can help. Find out what clients say about working with me here link.
My very best wishes

Isabelle C. Widmer MD

Image credit: Fabrice Prost, ICRC restrooms, ICRC, Geneva, Switzerland.