|You might favor this bill if:
► You believe that Americans shouldn’t pay more for prescription drugs than the median price of the following five countries: Canada, the United Kingdom, France, Germany, and Japan. You believe that prescription drug prices for patients in the United States should be significantly lowered by ending government-granted monopolies for manufacturers who charge higher drug prices.
|You might oppose this bill if:
► You believe that the prescription drug prices for patients in the United States is at an affordable price and should not be lowered.
The Prescription Drug Price Relief Act identifies excessively priced drugs. A year after the date of enactment of this Act, a review shall be conducted of all brand name drugs to determine whether the price of such a drug is excessive.
When the price of a brand name drug exceeds the median price charged for such drug in the following countries: Canada, the United Kingdom, Germany, France, and Japan, then that brand name drug is excessively priced.
A drug can also be determined to be excessively priced by checking the following;
● Size of the affected patient population;
● The value of the drugs to patients, including the impact of the price on access to the drug and the relationship of the price of the drug to its therapeutic health benefits;
● The cost associated with the development of the drug;
● The cumulative global revenues generated by the drug;
● Whether the drug provided a significant improvement in health outcomes, compared to other therapies available at the time of its approval;
● Whether the domestic average manufacturer price of the drug increased during any annual quarter by a percentage that is more than the percentage increase in the consumer price index for all urban consumers for the respective annual quarter.
Any petition submitted about an overpriced drug will be made publicly available, including adding such information to the database.
The bill also ends government-granted monopolies for excessively priced drugs. If the price of a brand name drug is determined to be excessive, any government-granted exclusivity with respect to such drug will be waived or void, effective on the date that the excessive price is determined for such drug.
Also, an open, non-exclusive license shall be granted allowing any person to make, use, sell or import into the United States such drug and to rely upon the regulatory test data of such drug.
If the manufacturer of an excessively priced drug has increased the price of his drugs, a civil action in the United States can be taken against such manufacturer in the district where the manufacturer is located or in the United States district court for the District of Columbia, to recover damages in an amount equal to the total amount of revenue derived by the manufacturer as a result of any such price increase during the period.
The bill also includes an excessive drug price license, which means that any manufacturer or company accepting an open, non-exclusive license will have to pay a reasonable royalty to the holder of the patent that claims the drug.
The royalty paid will be a percentage of sales, where the percentage rate is no higher than the average royalty rate estimated from the data provided by the Internal Revenue Service.
Or, it could also be an amount determined by taking into account the value of the drug to patients, the size of the affected patient population, the risk-adjusted value of the Federal Government subsidies and investments related to the drug.
We’ll also take into account whether the drug provided a significant improvement in health outcomes, compared to other therapies available at the time of the approval. Also, the extent to which the brand name drug manufacturer has recovered risk-adjusted investments related to the drug, including the investment related to the invention and other research and development costs.
All other information determined to be appropriate will also be taking into account.
The bill also includes maintaining an excessive drug price database. A comprehensive, up-to-date database of brand name drugs and the excessive price determinations for such drugs will be established and maintained.
The database created will include the name of the drug, the manufacturer, whether the drug was determined to have an excessive price. The number of petitions received in relation to the drug will also be included. The number of open, non-exclusive licenses that have been granted will also be stated.
In the bill, each manufacturer must submit an annual report that includes various information for each brand name drug of the manufacturer.
The information submitted should include the following; the average manufacturer price of the drug in the United States and in the 5 other countries which includes Canada, the United Kingdom, France, Germany, and Japan.