EU pharma reform: what to know

We sat down with BIO experts to take a deep dive into the new EU pharma reform package—here’s what you need to know. Plus, to kick off National Women’s Health Week, Bio.News and the CDC have three steps to better health. (624 words, 3 minutes, 7 seconds)

EU pharma reform: The good, the bad, and the next steps

The European Commission released proposals for the Pharmaceutical Directive and the Pharmaceutical Regulation and a proposal for protecting IP. Here’s what BIO’s experts say about the proposals.

In a nutshell: The “largest reform in over 20 years” for EU pharma would reduce market exclusivity for new drugs from 10 years to eight, but also streamline drug approval and encourage antimicrobial development.

Challenges for SMEs: The plan provides longer market exclusivity to drugs that launch in all 27 EU countries within a short time, which will be difficult for all companies, especially smaller firms, says Hilary Stiss, who leads BIO’s EU pharma law project.

Weaker IP safeguards, inspired by the WTO’s COVID IP waiver, combined with the shorter period of market exclusivity, raise concerns, says Justin Pine, BIO’s Senior Director for International Affairs.

A positive boost: New antimicrobials would get some support, as would orphan drugs for rare diseases—“a great step in the right direction,” comments Emily Wheeler, BIO’s Infectious Disease Policy Director.

The big picture: The proposal offers “a clear signal that the European Union would like to evolve the way it regulates, to promote innovation in the sector,” says BIO’s Chief Policy Officer John Murphy.

The next steps: The proposals are expected to change before the EU Parliament and European Council approve. BIO will be working to ensure the final legislation supports innovation and patient access. 

Read our exclusive analysis in Bio.News.

National Women’s Health Week: 3 steps to better health

National Women’s Health Week began yesterday—Mother’s Day—with the Centers for Disease Control and Prevention (CDC) shining a spotlight on the unique health needs of women.

3 easy steps for women to safeguard their health,according to Bio.News:

1. Schedule a checkup. Whether it’s a pap smear, mammogram, or general preventative checkup, it’s best to see a doctor before you get sick. (P.S. The U.S. Preventive Services Task Force now says mammograms should begin at 40, not 50.)

2. Don’t ignore mental health. Young women have the highest risk for mental health challenges, and risks are even higher for Black and Asian women and women facing poverty, says Agenda Alliance. If you have concerns, speak to a professional.

3. Consider your diet and keep moving! A diet rich in fruits, veggies, whole grains, and proteins from varied sources, as well as moderate-intensity aerobic exercise and muscle-strengthening activity, are key to health and longevity, says the CDC. 

Read and share the whole thing.

More Reading: 3 key insights to fostering successful collaboration in women’s health

More Listening: I am BIO Podcast says we need to ‘get uncomfortable’ talking about women’s health

 

More Health News: 

Reuters: G7 plans new vaccine effort for developing nations
“The Group of Seven (G7) rich nations is set to agree on establishing a new programme to distribute vaccines to developing countries at next week’s summit of leaders, Japan’s Yomiuri newspaper said on Saturday.” 

The New York Times (Opinion): 13 takeaways for the next health emergency
“The United States is repeating its panic-and-forget approach to crises. Unless we adopt smart policies, in the next health emergency America will again rely on improvisation, trial and error and luck rather than data, planning and preparedness,” conclude members of the Biden-Harris Transition Covid Advisory Board.

President Biden’s Monday: Returning from his weekend in Delaware.

What’s Happening on Capitol Hill: It’s a quiet day. Tomorrow, the House Ways & Means Committee will hold a hearing on “Health Care Price Transparency: A Patient’s Right to Know,” and Wednesday, its Health Subcommittee plans a hearing on “Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets.” House hearings on Wednesday and Thursday will examine China’s “economic aggression.” ICYMI: The four House and Senate Agriculture Committee leaders released a joint statement calling for passage of a bipartisan Farm Bill this year—which they called “a jobs bill.”