Tech Companies and the Uncertain Future of §230

While there has long been controversy surrounding how far regulating the Internet should go, it seemed that the 2016 election has had major impacts on how and what information consumers should and should not see. One law at the center of what the responsibilities are of an Internet Service Provider (ISP) is 47 U.S. Code § 230. 

The law which is part of the Communications Decency Act (CDA), also called Title V of the Telecommunications Act of 1996, provides ISP’s with federal immunity to any cause of action that seeks to make ISP’s liable for information that originated with a third party service user.

Specifically, §230 states: “No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” Additionally, when it comes to civil liability: 

“No provider or user of an interactive computer service shall be held liable on account of—

(A) any action voluntarily taken in good faith to restrict access to or availability of material that the provider or user considers to be obscene, lewd, lascivious, filthy, excessively violent, harassing, or otherwise objectionable, whether or not such material is constitutionally protected; or

(B) any action taken to enable or make available to information content providers or others the technical means to restrict access to material…”

This law preempts any contradictory state oversight. 

As the Internet and data sharing become more central in our lives, we are seeing more calls for regulatory oversight. Democrats have called for legislation on §230 as they believe that the law allows tech companies to not moderate content enough while the opposite viewpoint is being argued by Republicans. This fight continued into the eventual inclusion of §230 language in the recent passage of the new United States-Mexico-Canada Agreement (USMCA). While the tech industry views the inclusion of this language as necessary for legal certainty abroad, it remains to be seen whether we have heard the last of this domestic political argument. 

There is no doubt that §230 has allowed both the Internet and tech companies to grow. However; with worries growing over privacy and who owns individual data, we expect questions to continue over how far policymakers can go in creating regulatory oversight without inadvertently creating a “chilling effect” on first amendment expression. If you are a technology or content stakeholder and you have questions about state or federal legislative/regulatory data policy, contact us so that we can help you strategize for upcoming developments.    

What Will Happen to Biosimilars in the USMCA Agreement in 2020?

Back in August I started an analysis of how biosimilars will be impacted in the new United States-Mexico-Canada Agreement (USMCA). To refresh, in a follow up on a 2016 campaign promise to renegotiate the North American Free Trade Agreement (NAFTA), the Administration has been engaging Mexico and Canada in an effort to create and ratify the USMCA. 

One of the major points of contention in the negotiation centered on the exclusivity period of biologics. Biosimilar manufacturers raised concerns about the fact that the USMCA would award biologic manufacturers 10 years of market exclusivity. 

Fast forward to December 19, 2019 when the U.S. House of Representatives approved the USMCA with a bipartisan vote of 385-41. When it comes to biologics, the status quo remains as the exclusivity period continues to be 12 years. A provision that would have guaranteed 10 years of market exclusivity for biologic drugs was stripped out of a deal between Congress and the Administration. 

Senate Majority Leader McConnell (R-KY) stated that the U.S. Senate would consider the measure in early 2020. The reason for the delay according to the Senator is due to the looming impeachment trial for President Trump. Stay tuned for developments.

If your organization intends to either start or increase your utilization of biologic/biosimilar products or you are interested in understanding how to invest in these emerging products, contact us today. 

How Will the United States–Mexico–Canada Agreement Affect Biosimilars?

This article appeared in The Center for Biosimilars.

For years we have witnessed the fierce debate over whether the North American Free Trade Agreement (NAFTA) is serving the best interests of the United States. In following up on a 2016 campaign promise to renegotiate NAFTA, the new NAFTA, called the United States–Mexico–Canada Agreement (USMCA), is currently being debated by Congress, and there are concerns as to whether the agreement will be ratified.

Since Democrats control the House, Speaker Nancy Pelosi, D-California, is a major factor in determining how fast this agreement moves through Congress. One of the major Democratic points of concern is how prescription drugs, namely biologics, are handled in the USMCA.

The point of contention for biologics occurs in the agreement’s exclusivity period. Biosimilar manufacturers have raised concerns about the fact that the USMCA would award biologic manufacturers 10 years of market exclusivity.

The USMCA would not change the current biologic exclusivity in the United States. According to the current US law, “With regard to protecting new biologics, a Party shall, with respect to the first marketing approval in a Party of a new pharmaceutical product that is, or contains, a biologic, provide effective market protection...for a period of at least ten years from the date of first marketing approval of that product in that Party.”

However, the USMCA would raise the exclusivity timelines in Canada and Mexico, which could impact biosimilar manufacturers operating in those markets.

Supporters argue that the exclusivity period doesn’t change existing US law, innovators need time to recoup research and development costs, and drug costs may be reduced in the United States, since subsidization would be reduced due to the expansion of biologic exclusivity in Mexico and Canada.

USMCA critics, however, argue that the Administration’s Blueprint to Lower Drug Prices featured greater biosimilar utilization, and the USMCA contradicts this goal. The Association for Accessible Medicines (AAM) argues in its position that the “USMCA expands the definition of biologics, doubling exclusivity for certain medicines” and “expands the scope of drug exclusivities beyond US law.” According to AAM, “All of these issues should be conformed to the US Hatch-Waxman Amendments and the Biosimilars Law [the Biologics Price Competition and Innovation Act].”

So where does all this leave us? Negotiations between the Democrats and the Administration’s trade czar, Robert Lighthizer, continue. Going into an election year, the USMCA could serve as political fodder. Democrats may use this to criticize the President’s foreign policy while the President could make good on his threat to invoke the 6-month notice period and withdraw from NAFTA, but that action could be risky, since the economic effects are unknown going into 2020’s election.

One thing is certain; prescription drug prices remain a potent political issue where change has been called for by the electorate. Will the USMCA’s current form be enough or will further changes be realized?