At a recent EU meeting in Luxembourg, Poland supported a European Commission proposal to shorten the time new drugs are protected by data exclusivity rules. Health Minister Izabela Leszczyna said Poland prefers one year of market protection over longer periods of data protection.
In April 2023, the European Commission suggested reducing the data exclusivity period for drugs from eight to six years. Minister Leszczyna agreed, saying this would help people access new treatments more quickly without adding extra paperwork. She also proposed one year of market protection for new uses of existing drugs instead of extending data protection.
Balancing Incentives and Access
Minister Leszczyna emphasised that Poland supports measures to ensure all EU countries have access to modern treatments. She suggested that incentives should focus on market protection and not last longer than a year. For drugs treating rare diseases, extending protection could be considered, but for other drugs, different solutions should be found.
Challenges in Generic Drug Production
Krzysztof Kopeć, President of the Polish Association of Pharmaceutical Industry Employers, highlighted issues with drug shortages, especially for generic drugs. He explained that producing drugs in Europe is becoming less profitable, leading to shortages. Although the European Commission wants to boost drug production in Europe, current regulations do not support this, and production costs are higher in Europe than in Asia.
Concerns from Innovative Drug Companies
Innovative drug companies argue that changing existing intellectual property rules is not the answer to drug access problems. They believe the current rules should continue to support innovation and ensure EU patients can access new treatments. Michał Byliniak, General Director of INFARMA, stressed the need for EU reforms to improve drug supply security, availability, and affordability while also supporting new drug development.
INFARMA is discussing potential risks of shorter protection periods with the Ministry of Health and other stakeholders. They warn that reducing protection could limit access to advanced treatments. INFARMA supports keeping current data protection levels and creating incentives to promote innovation, address unmet medical needs, and encourage research in the EU.
Poland's support for a shorter data exclusivity period shows its commitment to balancing access to new treatments, innovation, and economic realities in the EU drug industry. As discussions continue, the goal remains to create rules that ensure safe, effective, and affordable medicines are available to everyone in Europe.
If you're among the people who used GoodRx to get discounts on your medications, the prescription shopping website might've done more than what you bargained for. GoodRx sent your personal health data to tech companies like Meta and Google for advertising purposes as well as the data brokers.
The FTC recently announced that GoodRx has agreed to pay a $1.5 million fine and implement various measures to ensure that the company no longer sends health data for advertising purposes. GoodRx has agreed that it will take user consent before sharing health data for other purposes, and also to get in touch with the third parties with whom it earlier shared sensitive info to delete that data.
Consumer Reports said, "to determine how GoodRx shares data, we monitored traffic using a data packet-capturing tool to observe the company's Android mobile app and website as we searched for deals on a number of prescription medications."
Several of the company’s business partners received the names of the medications, along with ID numbers and other information that can be used to single out individuals. The data can reveal intimate information that many people would keep private from all but their close friends and family.
The FTC alleged that GoodRx shared names of medications people were looking for on the application, it has been accused of sending lists to Meta, which includes identity info of users who bought certain medications, Meta used it to target users with ads.
“Digital health companies and mobile apps should not cash in on consumers’ extremely sensitive and personally identifiable health information. The FTC is serving notice that it will use all of its legal authority to protect American consumers’ sensitive data from misuse and illegal exploitation," Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a statement."
Some of GoodRx's practices were first disclosed in February 2020 by reports from Gizmodo and Consumer Reports, which explained how user data was being sent to third parties. GoodRx apologized for it, saying the data wasn't used for targeting ads and implemented some privacy measures.
Vox said "That seemed to be the end of it, as GoodRx operates in a digital privacy gray area. Though it may collect the same data that pharmacies, doctors, and health insurance companies do, in most cases it’s not beholden to the same health privacy laws — namely, HIPAA, the Health Insurance Portability and Accountability Act. Even when HIPAA didn’t apply to GoodRx, the FTC says that the company gave users the impression that it did by putting a little “HIPAA” icon on its website."