We are often asked why we can’t quickly change the laws related to rare disease therapy approval.  The answer is that not only are politics always involved, it’s that the process is very complicated. What often happens in the process … what is needed seems very clear to us, but what is introduced, hopefully passed, and then implemented can be dramatically different.

Often the reason for  many discrepancies is a combination of two things … one’s perspective and the impact of committees of people with vested (political) interests all reconciling their own interests.

If you can remember back to your high school US civics class (the process is similar in many other countries) you will recall that there are three branches of the US government … legislative, executive and judicial.  A bill is introduced, refined, and passed in the Legislature, signed or vetoed by the President, and then litigated, if necessary, by the Courts.

Our focus here is on the legislative part of the process.  Like an onion, when we peel away the outer layer, the details are much more complicated than we ever learned in civics. This chart (click to enlarge) details the many separate steps a bill goes through in the House and Senate.

The House and Senate work entirely independently and, hopefully in parallel.  It’s important that bills begin on both sides  the Hill and that they evolve in similar fashions so they can be “reconciled” after their respective approvals before the final bill is sent to the President signature. There is a lot of discussion and negotiation along the way.

The Journey

  1. The bill is introduced and assigned a bill number.  This requires draft legislation, and these days, it’s best to have two co-sponsors, one Republican and one Democrat.
  2. The bill is assigned to a committee
  3. A sub-committee takes control of the bill … here we compete with the other bills on that committee’s plate
  4. Hearings are held … usually public, where we can show our support for the bill and explain in more detail the need
  5. The sub-committee suggests it’s changes in a process called Mark-up … here we help to make sure the bill is not so watered down or changed that it loses its focus.  The politics of getting to  and through mark-up relatively unscathed can be very political.
  6. The full committee has a go at Mark-up … the bill may, at this and subsequent points, be attached to some bigger legislation as a “rider” – so the bill passes and fails based on the bigger legislation.
  7. The Rules Committee … gets their chance at the bill.
  8. The gets put on the Calendar for the full House or Senate to debate the bill.
  9. Finally, the Floor action is taken … debate, discussion, & review.  Often amendments to the bill are presented and voted on at this stage as well.
  10. Vote … the bill is put to a vote of the full House or Senate.  Hopefully, the bill has arrived at both houses at similar times for vote – but often, since the politics of the two bodies are different, one body is faster than the other.  A bill passed on only one side of the Hill cannot proceed until the other side takes action.
  11. Conference Committee … so now there are two usually slightly different versions of the bill passed.  This committee reconciles the differences into one final bill which is presented to the President for signature
  12. Presidential Signature … once signed a bill is finally law.  But here the president may just as easily veto the bill rejecting it back to the Hill to start all over again.  Depending on the legislature this decision can be very political as well.

How We Can Get Involved

The public can, should, and is encouraged to  be involved at all point in the process.  There are a couple of general themes that are most helpful …

  • General awareness …  support for a bill is often based on the practical content and budget impact of a bill, but equally it is a result of the individual Congressperson’s awareness of the issue the Bill is addressing.  It is very important to raise general awareness of issues, like the fact that RARE Disease affects 1 in 10 Americans, well in advance of asking the representative to do anything about it.
  • Sponsors … finding and engaging the key co-sponsors and then getting other members to “sign-on” gives the bill key credibility and momentum.  We recruit “sign-ons through the process.
  • Hearings … making our voice known succinctly both at the hearings and through written and phone contact keeps the bill moving and shows public support
  • Calendar/Vote … again, keeping the pressure on for progress and a broad show of support keeps the bill moving hopefully intact.

Every contact from the public is important whether it comes by phone, email, FAX, or in person.  Most congresspeople are very sensitive to their voting constituents.  And while there are hundreds of millions of voters, a few thousand can have their voices heard very clearly with a powerful impact as indicative of the general public.

We are committed to keeping you informed about legislation that affects our community. We hope to educate you on the content of various bill so that you can make up your own mind about the issues being addressed.  In partnership with the RDLA, who advocate in a non-partisan fashion on behalf of RARE disease, we also have access to extremely easy to use tools to make our voices heard clearly on the Hill.

written by : Dean Suhr, Chief Innovation and Community Development Officer, Global Genes | RARE Project