What kind of progress has Porzio made over the last year and what were some company initiatives?

PorzioLS has provided legal, regulatory and counseling services to the life sciences industry for over 40 years. PorzioLS has grown to offer a varied portfolio of compliance tools and services that help our customers comply with HCP compliance laws, regulations, industry codes and industry standards around the world. We are an umbrella organization with both legal and regulatory compliance all under one roof. 2019 was our best year to date and exceeded the prior year by 15%. We provided global transparency reporting services and systems in 46 countries around the world and continue to add a significant number of new companies every year. Overall, we have assisted over 500 life sciences companies. 

Many companies lack the internal resources to handle their reporting and so we have created an easily outsourced service. Even large organizations are looking to us for reporting and to have access to our systems, so they can see the data for auditing, monitoring, analytics and business intelligence. We have been able to get much more involved in dealing directly with our clients' business units, sales forces and third party vendors to ensure the information is accurate and complete. In the past, this was handled by internal life sciences personnel. Now, Porzio has become an outsourced transparency and aggregate spend office for many companies.

Our biggest initiative for 2020 is the launch of Porzio TPE (Third Party Engagement) software, a cradle-to-grave system where we provide a robust workflow system to handle global HCP engagements, as well as other types of third party engagements. With Porzio TPE we can provide a solution to handle a company’s upstream data and workflow requirements.

The first service and system we ever built was PCD, a series of online databases where we track regulations and analyze them so that companies understand how to operationalize their business to be compliant. Our systems track regulatory requisites and allow for clarity, simplicity and proper planning.

Geographically, where is the majority of Porzio’s growth coming from?

Most of our growth has been within the United States although we gain increasingly more from outside the US every year. We also have work from European companies never having done business in the US and now looking to create US commercial operations. For example, a significant area of business growth has been from mergers, spin-offs, and private equity and venture capital investments in life sciences. We also represent R&D companies that have decided to commercialize themselves and are seeking FDA approval of their products, hiring contract manufacturers and contract distributors, as well as field-based personnel.

What is your assessment of how the regulatory landscape has evolved over the last few years?

One of the legal areas strongly impacting companies and how they market their products is the push for price transparency. There are currently 14 US states with cost disclosure laws. In four of them, companies have to justify the price of their new products. For example, they are required to share what percentage of the price is attributable to research and development, licensing fees, sales forces and marketing. In some states you have to declare and rationalize price increases. Companies are considering how price increases might trigger reporting demands.  Some companies have pledged to limit their price increases. More and more states are asking for the disclosure of typically confidential information. These laws most notably were put in force after the Martin Shkreli ("Pharma Bro") scandal.

As a result of this regulatory pressure in the US, some companies have determined parallel approvals are safest, looking for approval in Europe as well as in the US. Organizations are becoming global earlier and a big reason for that is the price pressure in US. Lower prescription prices are also becoming a strong campaign message for politicians.

How do transparency laws compare with laws in other markets?

France has the most comprehensive regulatory framework. It has many types of covered practitioners, not only healthcare practitioners, but also patient advocacy, support organizations, and more.  At the end of 2019, France amended its laws to track all payments linked to social media influencers in connection with drug marketing.

The US has complex regulations, but we do not have the data privacy issues they face in Europe. It's important to note that, due to the global nature of companies, regulations from one country are incorporated into their global compliance program. Data privacy is significantly stricter in Europe than in the US. However, some companies are still incorporating GDPR into their global compliance policies outside the EU.

What would you like to achieve for Porzio in terms of strategy?

Porzio wants to continue to build on our services. As an organization, we began providing services by supporting companies in their state compliance needs and today, we have evolved to handling state, federal, and global compliance. We will continue to be a global compliance leader for the life sciences industry. We want to continue to be recognized as a unique organization able to provide systems, services, and regulatory and legal guidance under the Porzio family of companies.  Porzio is a one-stop-shop where governance, process, and systems together satisfy compliance obligations and provide a sound foundation for a biopharmaceutical company's operations.