The pharmaceutical industry is trying to fend off regulators on both sides of the Atlantic. By Sept. 1, the Biden administration is expected to announce the first 10 Drugs for which it will seek price reductions for Medicare under a provision in last year’s Inflation Reduction Act. That’s prompted lawsuits from drugmakers — Johnson & Johnson, Merck, Bristol Myers Squibb and Astellas Pharma — plus the U.S. Chamber of Commerce and the industry’s Washington lobby, the Pharmaceutical Research and Manufacturers of America. Across the pond: In Europe, the industry faces major regulatory changes aimed at driving down prices as well, POLITICO’s Helen Collis reports. The EU’s proposed overhaul of its rules around medicines will fundamentally change the European pharma market’s competitiveness, drugmakers say. Planned changes announced in April will squeeze pharma’s market protections for new drugs unless they’re breakthrough treatments quickly made available to all EU citizens. Measures include cutting from eight to six years the period that data underpinning new drugs will be protected from competitors, affecting about a third of innovative drugs where their data-protection period outlasts their intellectual property protections. An extra six months’ market protection will be awarded to drugs that meet a high unmet medical need, with another six months if the company carries out comparative clinical trials, and an extra two years if companies make their products available in all EU countries within two years. China bound? Pharma executives say it’s impossible to meet those conditions as they stand and have threatened to move their European research abroad. “Science is fluid, and it moves away from Europe,†said Lars Fruergaard Jørgensen, CEO of Novo Nordisk and president of the European Federation of Pharmaceutical Industries and Associations. “Innovation then moves to the U.S., China,†he said at a June event held by the federation.
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