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Speaking at an Executive Forum breakfast briefing, Spain’s Secretary of State for Health, Javier Padilla, used a FIFA World Cup analogy to frame the Ministry of Health’s pharmaceutical policy agenda, warning that Spain and the EU must protect their medicines access systems from unilateral pressure by the U.S.According to Padilla, FIFA's decision to overturn U.S. striker, Floarin Balogum's red card showed an actor intervening “basically because it could”, and argued that the same logic is visible in U.S. pharmaceutical policy“So, the question shouldn’t be why [Trump] is doing it, and some sort of quasi-psychoanalytic dissertation on why Donald Trump does what he does in terms of pharmaceutical policy, but rather what can be done at the European Union level and at the Spanish level to prevent the whims of someone like Donald Trump from influencing our ability to access specific medications when we need them,” Padilla added
Last week, NAVLIN Daily brought you key market access developments from across the globe. Japan began discussing its FY2027 off-year drug price revision, while Germany revisited its proposed dynamic manufacturer discount Meanwhile, U.S. MFN policy remained in focus, with Denmark raising concerns over future access to new medicines and Spain approving a legal amendment prohibiting the disclosure of medicine prices paid by public health authorities China kicked off its NRDL review process, assessing 818 drug submissions for its National Reimbursement Drug List (NRDL) and Commercial Insurance Innovative Drug List. Of 674 generic names reviewed, most passed
Germany's governing coalition has reportedly agreed to abandon plans for an annually recalculated manufacturer discount for patented medicines, opting instead for a substantially higher fixed rebateAccording to German media reports, the statutory manufacturer discount would increase from 7% to 15.5%, providing greater pricing certainty for industry while significantly increasing the financial burden on manufacturersThe move follows ongoing criticism from the pharma industry, which argues that a dynamic rebate would undermine long-term investment planning
India has introduced two major amendments to its pharmaceutical regulatory framework, with one reshaping the regulation of essential medicine prices and the other formally bringing stem cell-derived products, gene therapies, and xenografts under the country's drug lawsThe first amendment, notified by the Ministry of Chemicals and Fertilizers on June 30, revises the Drugs (Prices Control) Order (DPCO), 2013, under which the National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices for essential medicines. The changes primarily affect how those prices are implemented and enforcedIn a separate notification, the Ministry updated the Drugs Rules, 1945, to formally include Cell or Stem Cell-derived products, Gene Therapeutic Products, and Xenografts within India's drug regulatory framework
A new BMJ analysis argues that the recent U.S.-UK pharmaceutical trade agreement could divert an estimated £45 billion toward higher medicine spending, reducing National Health Service (NHS) resources available for other health servicesThe authors estimate the deal could be associated with approximately 229,000 excess deaths by 2036, driven by increased healthcare spending on medicines rather than broader patient careThe study also questions whether the agreement’s benefits will materialize, noting that higher prices may do little to expand access, innovation, or economic growth
China's National Healthcare Security Administration (NHSA) reviewed 818 drug submissions for its National Reimbursement Drug List (NRDL) and Commercial Insurance Innovative Drug List. Of 674 generic names reviewed, most passed, with record submissions reflecting a booming industryNotably, GLP-1 drugs for diabetes and weight loss, like those from Innovent and Pfizer, cleared the first hurdle but face price cuts to match hospital benchmarksPre-application drugs must meet the regulatory documentation deadline of July 3 to stay in the game. Public scrutiny adds another layer to ensure transparency, with the NHSA inviting public comments on candidate drugs until July 5
Biotech’s long-term pricing power hinges on “the capability of creating differentiated new therapies with more consistent and frequent innovation,” Dr. Yale Jen, Senior Managing Director and Healthcare Equity Analyst, told NAVLIN DailyIn China, the expert advised the global industry to consider “the level of local competition, even with less effective therapies...given the potential preference set by the government for local developers”“For an innovative therapy, China will still be a good farmhouse for ex-China players to develop a potentially better product in shorter timeframes, leveraging R&D for established molecular targets, a strong suite for Chinese biotech, and sometimes government subsidies,” said Dr. Jen
Last week, NAVLIN Daily brought you key market access developments from across the globe. Switzerland explored a new fund to support access to innovative medicines amid MFN concerns, Japan warned of growing drug lag risks from MFN, and China launched its 12th VBP round covering 65 drug varieties. The U.S. launched a Section 301 investigation into Germany’s pharmaceutical pricing and reimbursement policies, arguing they undervalue innovative medicines and shift a disproportionate share of global research and development (R&D) costs onto American patients Spain and Italy advanced pharmaceutical policy reforms, with Madrid opening a consultation on its Decree to regulate medicine prices, while Rome weighed updates to reimbursement rules to help curb rising pharmaceutical expenditure
The Japanese government is poised to strengthen incentives for pharmaceutical innovation while pressing ahead with plans for an off-year drug price revision in FY2027, according to a draft of its annual Basic Policy on Economic and Fiscal Management and Reform ("honebuto") It also touches on expanding the cost-effectiveness assessment (CEA) framework, againSeparately, Japan's ruling Liberal Democratic Party (LDP) began formal discussions on this year's honebuto paper during a meeting of its Policy Research Council on June 26, where members once again warned that MFN and other foreign policy issues are eroding the attractiveness of the Japanese market
Spain's Health Commission passed a controversial legal amendment to prohibit the disclosure of the prices public health authorities pay for medicinesDespite strong criticism from civil society organizations and an opposition vote from Podemos MP Javier Sánchez, lawmakers largely supported the measure, characterizing it as an essential move to protect Spanish patients from potential negative consequences of U.S. Most Favored Nation (MFN) policy Rafael Cofiño, a member of parliament for the Sumar party, argued in favor of the reform, explaining, "A lack of confidentiality would cause pharmaceutical companies to delay product launches, and people in Spain would have to wait longer to access innovation"
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