The World Health Organization (WHO) released a new reported on global health expenditure, revealing that health spending is growing faster than the rest of the global economy, accounting for 10 percent of gross domestic product. The rise is particularly noticeable in low- and middle-income countries, where health spending is growing on average 6 percent annually, compared with 4 percent in high-income countries. Health spending in the WHO report comprises government expenditure, out-of-pocket payments, and sources such as voluntary health insurance, employer-provided health programs and activities by nongovernmental organizations. Governments provide an average of 51 percent of a country's health spending, while more than 35 percent of health spending per country comes from out-of-pocket expenses. The WHO report also highlights a trend of increasing domestic public funding for health in low- and middle-income countries and declining external funding in middle-income countries. Reliance on out-of-pocket expenses is declining around the world, albeit slowly. The report follows the release of a report by the U.S. Centers for Medicare & Medicaid Services, which expects Medicare spending to jump 7.1 percent in the current year. (See BioWorld, Feb. 21, 2019.)
The Swiss Agency for Therapeutic Products this year has started to enter information on good manufacturing practice (GMP) compliance as well as manufacturing authorizations related to Swiss manufacturers into the European Union's EudraGMDP database. That applies to all new or renewed manufacturing authorizations and related GMP certificates issued using new templates. That will allow replacing the current practice of issuing paper documents and should lead to easier information-sharing and efficiency gains for all stakeholders, the agency said.
The FDA released a second draft guidance aimed at supporting development of nicotine replacement therapies (NRTs) that could be sold as new FDA-approved drugs, similar to current prescription and over-the-counter NRT products. The latest guidance, "Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products," lays out framework for potential clinically relevant outcomes for smoking cessation products, such as reducing the chance of a smoker going back to using cigarettes long term. The aim is to describe new endpoints that are meaningful to helping currently addicted adult smokers, and that can promote innovation in NRT by outlining a broader set of criteria that can serve as the basis for new approvals. The first guidance, released in August, focused on data recommended to evaluate potential toxicities associated with orally inhaled nicotine-containing drug products (such as e-cigarettes) to inform the FDA's assessment of a product's benefits and risks.