Expanding Access to Affordable Drugs and Medical Devices Act
Summary
The "Expanding Access to Affordable Drugs and Medical Devices Act" aims to amend the Internal Revenue Code to provide tax-exempt status to organizations that manufacture and distribute drugs and medical devices to meet public health needs. This bill allows the Secretary of the Treasury, in consultation with the Secretary of Health and Human Services, to designate certain organizations as 'public interest drug or medical device health care organizations'.
These designated organizations would not lose their tax-exempt status under section 501(c)(3) solely because they manufacture or distribute drugs and medical devices. The bill also includes provisions to prevent conflicts of interest and ensure that funding is permissible.
Expected Effects
The act is likely to increase the availability of affordable drugs and medical devices by incentivizing organizations to manufacture and distribute them. This could lead to lower healthcare costs for patients and improved access to essential medicines and devices. It may also encourage innovation in the development of new drugs and medical devices that address unmet health needs.
However, the effectiveness of the act will depend on how the Secretary of the Treasury and the Secretary of Health and Human Services implement the designation process and affordability guidelines. There is also a risk that some organizations may exploit the tax-exempt status without genuinely improving access to affordable drugs and medical devices.
Potential Benefits
- Increased availability of affordable drugs and medical devices.
- Potential for lower healthcare costs for patients.
- Incentivizes the manufacture and distribution of essential medicines and devices.
- Encourages innovation in the development of new drugs and medical devices.
- Addresses unmet health needs and public health emergencies.
Potential Disadvantages
- Potential for organizations to exploit tax-exempt status without genuinely improving access to affordable drugs and medical devices.
- Effectiveness depends on the implementation of the designation process and affordability guidelines.
- Risk of conflicts of interest if not properly monitored.
- May create an unfair advantage for designated organizations over other manufacturers and distributors.
- Could lead to market distortions if not carefully regulated.
Constitutional Alignment
The bill appears to align with the general welfare clause of the Constitution, as it aims to improve public health by increasing access to affordable drugs and medical devices. The Constitution's preamble states the goal to "promote the general Welfare".
Congress has the power to lay and collect taxes, duties, imposts and excises, to pay the debts and provide for the common defense and general welfare of the United States (Article I, Section 8, Clause 1). This bill uses the tax code to incentivize certain behaviors that Congress deems beneficial to the general welfare.
However, the specific implementation and regulations issued under this act would need to be carefully scrutinized to ensure they do not infringe upon any other constitutional rights or provisions.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).