By Linda Rouse O’Neill
Vice President, Government Affairs, HIDA
Linda Rouse O’Neill
On a day-to-day basis, our focus is on our customers and responsibilities, which makes it difficult to step back and learn about the healthcare policies developing in states outside our sales territory. Almost every day, new legislation gets introduced across the country on state and local levels that has no immediate impact on the business we conduct in our own regions. However, sometimes an idea can gain traction so quickly that more states pay attention and introduce similar legislation. Some issues even have the potential to rise to the federal level with significant implications for our entire industry.
Sharps Disposal Ordinance Is Potential Disrupter For Manufacturers, Relabelers
For example, environmental producer responsibility discussions are currently underway in several counties and states, including California. Mandatory collection and disposal programs, or Product Stewardship Programs, are being discussed as a means to remove sharps from the solid waste stream.
The impetus behind the initiative is that many groups are affected by the lack of safe needle disposal programs, particularly individuals who are subject to potential harm by working in jobs where they could come in contact with needles (e.g., landfill workers, hotel employees, police officers). Many states have made it illegal for home injectors to dispose of needles and lancets in the trash, but there is no way to fully police this – another reason why Product Stewardship is being discussed.
Product Stewardship Program participants would be responsible for collecting, transporting, and disposing of sharps under proposed solutions. If implemented, this program would directly affect producers of injectable medications and manufacturers of sharps, since they would be required to pay for initial administrative and operational costs and fees associated with getting a program up and running. Distributors who relabel products would also have to account for any new products associated with safe sharps disposal.
Although discussions are in early stages, it’s easy to see how broadly our industry would be affected with the passage of any national legislation.
A growing list to follow
Policies unique to one state don’t always remain that way. Before the Drug Quality and Security Act was signed into law in 2013, a patchwork of 29 individual state pharmaceutical pedigree laws existed in competition with each other. HIDA and its members used this disconnect as an advocacy opportunity to strengthen and ensure a secure supply chain for patients and providers.
Shifting focus toward medical products, creating a national uniform medical-surgical wholesaler licensure standard has been a hot topic for more than two years and doesn’t appear to be losing momentum. HIDA has been collaborating with industry stakeholders and cultivating champions on Capitol Hill to introduce legislation which would create a predictable and efficient licensure standard for states to implement. This effort would ensure continuity and enhance security for the medical-surgical supply chain. In fact, lawmakers are working on legislation that is expected to be introduced soon.
Another local example we’re monitoring is in New York, where legislation has been introduced that would require suppliers to issue ten-year warranties on any medical product they produce—from adhesive bandages to MRI machines. While passage of this legislation would affect manufacturers of these products directly, it could have potential spillover effects for distributors carrying these products since they would be required to relabel all of their current inventories.
There are numerous other state and local discussions in addition to these, and it can be difficult to keep up with every new development. This year, HIDA is forming a state legislative workgroup to monitor, pool, and share information among suppliers wishing to take an active role in healthcare supply chain policy. Staying informed of these topics is the first step toward identifying new challenges and possible opportunities for your business and customers.
If you would like more information or to get involved in HIDA’s state legislative workgroup, email us at HIDAGovAffairs@HIDA.org.