General Counsel in 2019

  [smart_track_player url="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/ep162_podcast_for_general_counsel_recap_of_2019.mp3" title="General Counsel in 2019" color="#FF5722" social_linkedin="true" social_email="true" tweet_text="Listen to this @darshantalks podcast on #General Counsel in 2019!"] February 18, 2020 Darshan: We're going to be discussing a few different issues. We're going to start focusing and talking about just a recap of how 2019 went. And we're going to start by talking a little bit about should we think about the typical general counsel. Think about the typical lawyer. What are the big legal issues that happened in 2019? Narrator: This is the Darshan Talks Podcast, Regulatory Guy, Irregular Podcast, with host Darshan Kulkarni. You can find the show on twitter @darshantalks or the show's website at darshantalks.com. Darshan: So, let's start with the basics. One of the big things that happened if you are a US attorney, is how you engage with contractors. And this was unusual and unexpected because if you're a startup, if you're a mid-sized company, or even if you're a large company, you probably use a lot of consultants. Now, there was a April 2018 California Supreme Court decision, that has implications that kick in mostly starting 2019. And essentially, it changed the rules. What it came out and said is that there's a new test for employers. So if you're an independent contractor, the independent contractor must be free to perform their work as they wish. And they must be in a different line of work from the company contracting them, and must operate their own business. Darshan: So, what they really were initially going after were the Airbnb's of the world, and the Ubers of the world. But, it obviously has major implications on companies that aren't those types of companies. So, if you are a car driving company, the idea that all your drivers are consultants or contractors may not work as well. However, if you are a biotech, or if you are a medical device company, or you are some kind of health company, recognize that if you're in a startup phase, you're often using people as consultants and contractors, and that may not necessarily fly. Darshan: The impact of this is an additional 20 to 30% in labor costs, when you include Social Security and Medicare taxes, and unemployment and disability insurance. All of this suddenly adds up. Again, remember you're now suddenly exposed to all kinds of liability, including discrimination, sexual harassment. If you are using consultants out of California, if you are a business based in California, consider these issues. Darshan: The other thing that came into play is GDPR. As we know, that really started occurring more in 2018; however, the impact of that is really coming out in 2019. The overall awareness levels are high; however, how this actually impacts the life sciences sector is a little bit up in the air. It seems to vary from company-to-company. There are companies aware of it, there are companies who are not, and I'm not necessarily talking about small companies. I've heard through the grapevine that CROs are telling sponsors to stay outside the European Union because of the implications of that, and because of the methods that have to be taken to protect personal data that belongs to individuals. Darshan: Essentially, if you are a company that's processing personal data in relation to the offering of goods or services to individuals in the EU. Or, if you monitor the behavior of individuals in the EU, you probably need to comply with GDPR. Obviously, if you're doing clinical trials in the EU, that very much falls under the ambit of what GDPR includes. As we said that there are a lot of the European companies are aware of this.