The court must decide if this provision within the law is constitutional and, if not, if other provisions of the law―including the biosimilars pathway―can still be used or if new legislation will have to be passed.

The biosimilars industry is obviously concerned about this development, and in fact officials from injectable generics giant Hospira have told reporters that there will be a need to pass legislation re-establishing the pathway if the Court strikes down the entire healthcare law and that they have been talking to lawmakers about the need to plan for this worst-case scenario, although no legislation has yet been drafted.

Senator Patrick Leahy, however, argues that working Americans have long been required to pay for Social Security and Medicare (health insurance) by the deduction of taxes from their pay checks every month. He adds that the key to testing whether the law is constitutional under the Commerce Clause is whether the law substantially affects interstate commerce, which he argues it does.

The personal responsibility requirement that is the focus of the legal challenge is necessary to ensure that Americans who have paid for their health care by buying health insurance are not stuck with paying the US$43 billion in healthcare costs incurred by millions of Americans who do not buy health insurance and then must rely on expensive emergency health care when inevitably faced with medical problems. Congress concluded this after extensive study and debate, and this is what was included in the text of the law itself. Therefore, according to Senator Leahy, there is no question this act by Congress regulates matters undeniably affecting interstate commerce.

Despite all the speculation, Americans are already beginning to see some of the benefits of the Affordable Care Act. Seniors on Medicare who have high-cost prescriptions are starting to receive help when trapped within a coverage gap known as the ‘donut hole’ and young adults are now able to stay on their parents’ health insurance plans until their 26th birthday. According to Senator Leahy the law is making possible more and better care while still controlling costs.

Hospira officials have said that they are still moving forward in developing biosimilars, despite current uncertainties surrounding the law. The company is currently developing 11 biosimilars.

The Biotechnology Industry Organization has also said that the group is ready to defend the biosimilars part of the Affordable Care Act in the event the Supreme Court rejects the entire law. However, some drug industry attorneys have expressed concern that a move by Congress to reconsider the healthcare reform law could leave controversial provisions such as the biosimilars pathway, vulnerable to change, as biologicals exclusivity has been widely debated since the law’s passage.

Editor’s comment
This is obviously a worry for biosimilars manufacturers, and could mean serious delay if a new healthcare law including the biosimilars pathway has to be passed.

Please feel free to share your thoughts via email or in the comments section below. What are your views on this latest development regarding biosimilars? Would it be right to reject a whole law over a single provision? What can the biosimilars industry do to ensure that the biosimilars pathway remains available?

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