USA: the gold of the pharmaceutical industry for the development of new products?

USA: the gold of the pharmaceutical industry for the development of new products?


By Alexandra Pieve

The European Union (EU) and the United States (USA) are two of the most regulatory demanding healthcare systems in the world. However, it is possible that one of them is more attractive to the pharmaceutical industry than another. No system is better, but each has its differences. These differences can affect different departments of a pharmaceutical company.

From the start of a drug’s life cycle, we see that research and innovation are much more attractive in the United States than in Europe. This is why we see this phenomenon of migration of scientists to the United States, as the representatives of the Association of Spanish Scientists in the United States say (HORSE), which has more than 1,000 Spanish researchers in this country.

“The American system ensures that talent is recognized personally and publicly. This is achieved through a highly competitive research system, which adopts quality promotion measures. In Spain, however, the regulatory model of Spanish public universities was designed for different purposes and does not promote competitiveness between universities but rather homogenization. This can be positive for the educational mission of public universities, but it can affect the quality of research. “

Also, according to the magazine FranceEvening, a lot startups The French decide to go to the United States for better financing and a more agile development process. Therefore, from the start, we see that innovation is much more attractive for the pharmaceutical industry in the American country.

Launch and approval process

Europe and the United States have a very similar launch approval system for new drugs. This process, overseen by the FDA in the United States and by the EMA in Europe, it consists of different phases of clinical trials. First by starting with scientific evidence and clinical trials on animals, then clinical trials on potential patients.

However, in the United States, the FDA has mechanisms to process acceleration approval. The first concerns innovative treatments for low prevalence diseases or drugs that provide a substantial improvement over existing drugs. On the other hand, there are the generic drug approval processes. The FDA only asks for one Abbreviated New Drug Request (ANDA) which demonstrates that the generic is the same as the drug already marketed, without having to present the entire process of clinical test. So we see that the approval processes in the United States are looking to be more and more nimble.

On the other hand, in Europe, since it is not a single country, there is a first phase of “centralized” approval which is the gateway to price approval and reimbursement which is peculiar to each EU country, which makes the launch of new drugs or new indications lengthen.

Type of health system

Likewise, the type of health system in each of these two territories must be taken into account. In the United States, health coverage is based on the free market and private companies and insurance companies are the ones that handle much of the health care. As for the EU countries, many of them have a system of universal coverage and require price regulation by the state. For this reason, the process of bringing drugs to market in Europe is even longer. This means that, in European pharmaceutical laboratories, the services of market access be a key department.

Promotion

Finally, once the product is on the market, it is time for the marketing team to think about promoting the products. In the case of Europe, the regulation of drug advertising is very strict and only non-prescription drugs are allowed. In contrast, in the United States, a country where advertising of prescription treatments is permitted, laboratories are required to submit their promotional material to the FDA before launching it. However, the FDA cannot force companies to change their promotional material, it can only advise. This leaves more leeway for marketing and sales teams in the United States than in Europe.

These differences between the approval, research and advertising processes, which place the United States as a preferred territory for healthcare companies, can generate some inequalities in access to treatment.. In turn, this also robs us of great minds who are forced to leave their countries to get the recognition they deserve. However, with the Covid-19 health crisis, we could expect substantial changes and a homogenization or rapprochement between the models of the two major pharmaceutical powers.



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