Industry trade

The American pharmaceutical industry opposed patents – what has changed?

The United States, Europe and other wealthy parts of the world have already vaccinated large parts of their populations, but vaccination rates in poor countries are lagging far behind. That’s why the surprise announcement last spring that the United States would support waiving patent protections on COVID-19 vaccines is so important.

Drugmakers were quick to voice their opposition to the move, but public health advocates were thrilled. Waiver of patent rights, thought says, will give poorer countries the ability to procure low-cost generic versions of COVID-19 vaccines, even if produced in another country, and help them fight more effectively against a public health crisis. The European Parliament also supports the idea.

A patent waiver would of course have major implications for global vaccine production. But the US announcement must also be understood in the context of long-running US drug patent debates.

I am a historian who has studied these debates extensively. What is clear from my work is that heated disputes over the morality of drug patents date back to the earliest days of the American Republic, as do efforts to limit – even ban – patents on pharmaceuticals. . Support for drastically limiting patent rights on drugs, or even eliminating them entirely, is a far cry from the radical position that some critics imply. Indeed, in many ways it is a deeply conservative policy.

Opposition to the establishment

In the United States, the first drug patent was granted in 1796 for “Dr. Lee’s Windham bilious pills”, which were used to treat digestive and other problems. Over the next century, drug manufacturers produced an endless stream of products protected by both patents and trade secrets. Most of these remedies could be easily put together in a pharmacy, and some have clearly helped people.

Yet these so-called “patent medicines” were also highly controversial. Doctors and other critics have strongly denounced them because many were advertised with false or misleading claims. Physicians have also recoiled from the effort to monopolize these products.

Physicians of the time believed that medical science should benefit patients, not private commercial interests, and that medical knowledge should be shared and used freely. Patents and trade secrets have interfered with this process – after all, if a pharmacist could compose a cure cheaply, shouldn’t he be allowed to do so? Restricting access to drugs on the basis of patent rights has struck American doctors as deeply unethical.

The moral criticism of patenting was so strong that the American Medical Association made it a cornerstone of its first code of medical ethics in 1847, declaring that it was “derogatory to professional character” for a physician “to hold a patent for any surgical instrument, or Medicine.”

It was no laughing matter. Code compliance was a requirement for licensing in many states. Violating the patent prohibition could have serious professional consequences. In 1849, leaders in the medical community even tried to pass a law banning drug patents altogether.

This ethical framework also created the first market for what we now call “generic” drugs. A handful of companies began manufacturing standard preparations and completely avoiding the use of patents and trade secrets. After the Civil War, these companies became the largest drug manufacturers in the country. They also started to build laboratories and invest resources in the development of new products. After World War II, these companies grew into massive corporations and formed the backbone of the American pharmaceutical industry we know today.

Gear switch

Yet these companies have also abandoned the commitment to open science that made them rich in the first place. Beginning in the 1880s, a small number of American drug manufacturers began to advocate for the need to patent their products. They made arguments familiar today, suggesting that patents were necessary to stimulate investment in research.

Some doctors embraced the idea – mostly younger ones who chafed at the AMA’s rigid code of ethics – but it infuriated conservatives. They continued to denounce patents on pharmaceutical products as a form of quackery. As late as 1921, HK Mulford – one of the biggest drug makers of the time – maintained the conservative stance and refused to patent their products.

By the early 1950s, these debates were largely settled. Pharmaceutical companies had fully embraced patenting and, just as importantly, convinced the medical community to do the same. Indeed, as historian Dominique Tobbell has argued, the two groups worked together to thwart efforts to reign over pharmaceutical patents. By the 1980s, this powerful alliance had come to dominate government trade and regulatory policy. As a result, over the past few decades, the United States government has aggressively promoted pharmaceutical patents on the international stage. Indeed, the United States has led efforts to force other countries to strengthen their domestic patent laws to better defend industry profits.

Learn from the past

This is why I consider the United States’ decision to support the temporary waiver of COVID-19 patents to be so important. This signals a new willingness on the part of the US government to question the supposed sanctity of drug patents and other forms of intellectual property. It also reflects years of efforts by reformers to highlight how pharmaceutical patents limit access to medicines in poor countries.

Yet I believe more needs to be done – and fast. The United States should push for a waiver not only of the COVID-19 vaccine patents, but also of all forms of intellectual property that could interfere with the transfer of knowledge and technology needed to manufacture these complex products. . As others have pointed out, this alone will not be enough to increase global vaccine production. Still, it’s a necessary step because vaccine makers aren’t willingly sharing trade secrets and know-how on a large enough scale.

In my opinion, we desperately need to move towards an integrated global system of vaccine development that guarantees access to all. Whether there is a place for patents in such a system is an open question, but I am skeptical. 19th century physicians believed that drug patents interfered with science and harmed patients. The predecessors of today’s pharmaceutical industry did the same. It is time for all of us to remember this.

This article has been updated to indicate that the European Parliament voted in favor of the patent waiver for COVID-19 vaccines, not the European Union.

Gabriel is aassociate professor at Florida State University

This article is syndicated by PTI from The Conversation.