|It is time to stop the Big Pharma Bandits|
In the EU the latest broad charge by health care providers and the public of excessive pricing, also described by Brussels as “price gouging”, potentially sets a precedent for more direct action, especially if officials rely on a formula for what is a reasonable or justified profit margin.
Generic drugmakers and research-based pharma companies are used to facing each other in patent rows that can bring lost or gained earnings totaling many millions of dollars, but billions are riding on a European Union (EU) review of laws affecting exclusivity periods for the industry as a whole.
The European Commission is considering implementing a Supplementary Protection Certificate (SPC) manufacturing and export exemption, and has launched a consultation on the issue. The SPC compensates originator drug manufacturers for regulatory approval delays by extending their monopoly for up to five years after patent expiry. During this period, European manufacturers of generic and biosimilar medicines cannot produce their medicines in the EU.
It is felt that the waiver could boost economic growth and job creation within the generics and biosimilars industry, and the trade group representing these drugmakers in Europe is naturally pushing for the reform to go through.
Other findings from that report, sponsored by the European Commission, suggest that the waiver would enable savings in pharmaceutical expenditures of 1.6 to 3.1 billion euros thanks to competition and generate, together with a broader Bolar exemption, additional EU active pharmaceutical ingredient (API) sales of 211.8 million to 254.3 million euros by 2030, creating an additional 2,000 jobs in that sector.
Another major argument in the waiver’s favor is that it would bring faster entry of generic and biosimilar competition in the EU after SPC expiry, thus improving access for patients and reducing the overall medicines bill.
Medicines for Europe argues that the manufacturing waiver would not affect originator drug manufacturers as they will continue to benefit from the longest period of monopoly protection globally for most drugs. The group called for the European Commission to start legislating to make this happen.
Unfortunately not much has happened so far as a result of extreme lobbying efforts by the multi-national pharmaceutical industry in the EU Parliament,
In the US overcoming price gouging by multi-national pharmaceutical corporations also seem stalled.
Last January, in the USA, shortly before his presidency began, Donald Trump promised to end big pharmaceutical companies’ stranglehold on drug prices and the healthcare industry; but more than a year later, drug companies continue to face almost no competition in the US while steadily raising their prices.
Amgen (NASDAQ: AMGN) raised the price of its rheumatoid arthritis drug Enbrel by 9.7%; Biogen (NASDAQ: BIIB) tacked on another 8% to its multiple sclerosis drugs -- among them the popular Avonex -- and perhaps the most stunning: NextSource, which raised the price of its 40-year-old life-extending cancer drug Lomustine by 1,400%.
One of the main reasons that pharmaceutical companies can manage to hike prices so much is because of a lack of competition, Chip Davis, CEO of the Association for Accessible Medicines told FOX Business’ Liz Claman. Currently, 319 drugs on the market have no cheaper competitors in the form of generics.
“The reality is, ultimately, policymakers are going to have to decide whether there’s things they can do to enhance the market,” Davis said.