As the Sunshine Act becomes part of standard regulatory procedures, pharmaceutical companies are looking to further develop their compliance efforts. Many of our clients are looking to streamline their reporting processes and proactively identify potential compliance pitfalls. One key way to maintain consistency and accuracy in reporting processes is through a comprehensive assumptions document.
Fair market value (FMV) activities help life science teams develop consistent, defensible remuneration rates for the healthcare practitioners (HCPs) with whom they work. As part of their FMV configuration processes, companies may consider each HCP’s scope of influence and his or her specialty type. For example, life science teams may develop compensation rates based on three tiers:
• Tier 1 reflects HCPs or other industry influencers with global-level reach.
• Tier 2 indicates HCPs or other industry influencers with regional influence, and
• Tier 3 denotes HCPs or other industry influencers with a strong local-level following.
On June 23, 2016 the United Kingdom voted in a referendum to leave the European Union, to the surprise of most political observers. It must be noted the referendum does not have an immediate impact on the UK’s legal status as a member of the EU and negotiations under Article 50 for the formal withdrawal are expected to take up the maximum two years. However, the impact on the British economy has been immediate in terms of the pound sterling and the stock markets. Additionally, the political reaction sheds light on how the regulatory environment could change in the short and long term. Continue reading
From speaking engagements to advisory board leadership, healthcare practitioners (HCPs) provide an invaluable resource for pharmaceutical, biopharmaceutical and device companies alike. However, life science teams may struggle to develop fair market value (FMV) compensation rates for the important contributions that these HCPs and other medical professionals provide. Essentially, life science teams must balance competitive remuneration rates while also adhering to regulatory stipulations and avoiding the undue perception that they have bought HCPs’ support.
A common challenge facing life science companies is determining a pharma brand launch budget. No one size fits all because these budgets depend on a number of different factors, including product type, expected peak revenue and market circumstances. Add to this individual companies’ own resource limitations, and a designing a pharma brand budget becomes a very daunting task.
Pharma key account management (KAM) teams focus on strengthening relationships with existing client accounts and forging new ones. As an example, these teams may reach out to hospital systems to determine which products these organizations use (or would be interested in trying). Some life science teams designate specific KAM groups to handle commercial and market access account types. Others make no distinction across the different audiences that dedicated KAM teams may serve.
Pharmaceutical and biotechnologies are becoming increasingly strict with their physician compensation practices. Because more and more countries are implementing open payment legislations, life sciences firms must be prepared to develop and implement physician fair market value practices. These standardized payment methodologies ensure that the company offers its thought leaders the best fit compensation for their level of expertise and their contributions to the company’s research or promotional efforts.
More and more countries are implementing open payment legislation, similar to the US Physician Payment Sunshine Act. With these laws in place, pharmaceutical, biotechnology and medical device firms must be careful of how they are working with and compensating their key opinion leaders. These firms must standardize their key opinion leader compensation practices to avoid regulatory scrutiny and hefty fines.
Standardizing your global fair market value (FMV) methodology was the underlying theme at the 3rd Annual FMV of HCP and Investigator Payments conference in Philadelphia on May 9-10, 2016. What we at Cutting Edge Information are seeing right now is that many life science companies have different FMV methodologies for different countries. As more and more countries develop their own version of the US Open Payments Act, it is becoming increasingly important to remain consistent in your global methodology. Continue reading
Please Treat Me Better Than the Mice.
Here at Cutting Edge Information, we spend a lot of time researching how companies take products from pre-clinical through approval and then support those products once they reach the market. But sometimes a change in perspective is good. So a few weeks ago I enrolled in a Phase 1 clinical trial to see what the process looks like from the patient’s side. While I cannot go into great detail about the specific processes around the trial, I did have some observations for the industry that we all work in. Continue reading