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The 21st Century Cures bill has been unanimously been passed by the House Energy and Commerce Committee today with a vote of 51-0. This is the first major legislative bill to be passed without a single no vote in a very long time.
The bill has been some time in the making, with work starting in April of last year. The discussion draft of the bill was released early last week, with the markup version following a week before the vote. During the full committee markup period a number of changes were made to the bill, in particular the inclusion of mandatory funding for the FDA, although the figure of $550 million is much lower than it was seeking. However, since the since the bill has such strong support it looks likely to sail through the full house vote.
The popularity of the bill is understandable. The goal is to remove some of the major obstacles that are holding back medical research, and ultimately slowing down the rate at which new cures can be developed, especially for diseases that are currently untreatable. The recent Ebola epidemic highlighted the health dangers currently faced, and the need for new medicines and treatments to be developed.
At present, poor interoperability and legislative barriers are holding back medical research development and this is ultimately delaying the delivery of new treatments to patients and stopping them from receiving the very best medical care.
The bill will have an impact on HIPAA, as previously reported last week. HIPAA-covered entities will no longer be required to obtain authorization from patients to share data that is to be used for their care, and this extends to medical research. Security Rule protections will still apply to ensure the data is appropriately safeguarded, but patients will have less say in how their data is used.
The Department of Health and Human Services will therefore be required to update Privacy Rule restrictions if the bill is passed.
How the bill will fare in congress is open to speculation and support is unlikely to be quite so strong. Some may feel that it is a little optimistic to expect to get the bill before the President before the end of the year although some proponents of the bill believe this is a realistic goal.
The bill did get full support in this vote, but there are some that feel the provisions of the bill may reduce the standards that are now in place regarding testing new treatments. The pharmaceutical industry will benefit from a much longer period of product exclusivity but this too is opposed, in particular by the Democrats. On top of that privacy groups fear the legislation will reduce patient rights.
These problems with the bill are minor however compared to the not insignificant problem of where all the money is going to come from. There is an estimated $10-$13 billion required to introduce this new legislation and at this stage is not clear exactly where that money will come from.