Pharmaceutical industry and health: reform according to Garattini

The market and intellectual property work poorly: they do not guarantee the human right to health, they cause inequalities and injustices, they induce the formation of monopolies, they do not generate innovation, they are based on opacity and conflicts of interest.

The pharmacologist’s thesis Silvio Garattini is discussed in its latest volume”Patent health? A medicine without a market”, Conversation with the science communicator Catherine Visco.

“Self the current rules market, intellectual property and profit, do not guarantee access to health for all citizens, perhaps they must be reformed, made to evolve in order to put the interest of patients and society at the center”, writes the founder and president of the Pharmacological Research Institute – IRCCS Mario Negri.

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The volume is an agile and lucid guide to accessing the international debate on problems with the current drug production system. A system based on patents, industrial secrets, trademarks, copyrights.

The arguments are solid, accompanied by figures and facts, as well as some essential bibliographical references at the end of each chapter, and deserve to be deepened.

Pharmaceuticals and healthcare: how the system (doesn’t work)

The COVID-19 pandemic has tragically brought to light all the shortcomings of current drug manufacturing policy: globalization built in the mid-1990s a rigorous system of protection of intellectual property rights covering medical devices, drugs and vaccines on the basis that more exclusive rights would lead to more innovation. But this assumption has proven to be unfounded over time.

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Intellectual property favored the emergence of monopolies and the market has ceased to innovate: it is possible, complains Garattini, to patent and market drugs that do not present a real advance in terms of treatment (“added therapeutic value”).

States delivered all the power to big pharmawhich only produces what it promises to generate profit and not necessarily what people need.

Much of the innovation is due to Basic search universities, institutions and research institutes funded with i public funds (citizens’ money), but this innovation ends up being privatized pharmaceutical industries.

Gathering of university patents, cannibalization of companies born in academia (spin-offs and start-ups), appropriation of research results (publications and data) made freely available on the Internet, are some examples of privatization.

The citizens they buy at monopolistic prices directly or indirectly – in Italy through the national health system for products paid for by the State included in a special list – the medicines that have been developed also thanks to the taxes they have themselves- same paid.

In short, they pay twice for the same thing: the first time by paying the taxes that go to public research, the second time by buying the drug.

Continued, the price of the drug it includes not only the monopoly rent but also a part which it is used to cover the costs of industries totally unrelated to research and innovation: lobbying with public decision-makers (legislators, control agencies) as well as with doctors, brand advertising, other marketing expenses.

Pharmaceutical industry and health: the case of anti-Covid19 vaccines

Rare diseases and orphan drugs with no prospect of profit are ignored by the pharmaceutical industries: poor countries that cannot afford monopoly prices are forced out of the health market.

In this last respect, history presents us again with the moral catastrophe which saw the treatment of HIV/AIDS and hepatitis C denied to large sections of the population. The distribution of SARS Cov-2 vaccines is obviously imbalance: while the wealthy West provides the third and fourth doses of the serum, low-income countries cannot even administer the first.

The unequal distribution of vaccines causes injustice and increases the risk of spreading dangerous new variants of the virus. A rapid and equitable distribution of vaccines on a global scale would have prevented many deaths and enabled a rapid exit from the pandemic. It is therefore not surprising that Afrigen Biologics and Vaccines in South Africa recently announced that it had moved independently and had successfully reproduced Moderna’s vaccine, without the collaboration of the American company.

Drug control agencies aren’t working optimally eitheralthough the image has improved a lot since the 1950s. Clinical studies (trials) on quality, efficacy and safety are entrusted to the same pharmaceutical companies that produce the drugs, with an obvious conflict of interest .

Data relating to clinical trials are subject to ad hoc exclusivity (known as data exclusivity) which can be added to the invention patent.

In this respect, the recent editorial of the prestigious “The British Medical Journal” in which it was formulated caused a sensation. the call to henceforth publish the data relating to the clinical trials of the vaccines administered (Pfizer, Moderna, etc). For example, Pfizer declares giving access to the data from May 2025, Moderna from October 2022. Hence the request for immediate availability made in the British Medical Journal.

Pharmaceutical industry and health: Garattini’s recipe

Garattini’s recipe for improving current drug production policies is important and articulate.

1) Abolish drug brands to allow marketing with the generic name only.

2) Avoid patenting products that have the same mechanism of action but with a different chemical structure.

3) Warranty the patent only for products that demonstrate “added therapeutic value“Compared to those already existing.

4) Demonstrate “added therapeutic value” by comparative clinical studies carried out by independent scientific organisations.

5) If the new medicine is better, abolish the patenting of drugs with a less favorable ratio between risks and benefits.

6) Prohibit the patenting of products existing in nature: genes, proteins or physiological processes.

7) Experience, for example, of creation at European level groups of public structures and non-profit foundations with the right skills to be able to move from a drug idea, through preclinical research to phase 3 studies (those that involve a large number of patients and must determine validity, usefulness and usability).

What should be the outcome of reforming the patent system and experimenting with non-profit forms of research and entrepreneurship? We could induce a healthy competition between industries and not-for-profits promote the development of better drugs at lower cost.

Garattini shows that he knows how to reconcile vision and pragmatism.

“Perhaps in a world like today, it is not possible to find a single solution, but it is necessary to develop different measures; what should not be overlooked in practical speeches is the final objective: to guarantee access to health for all citizens, as affirmed by our Constitution and the principles of the World Health Organization […]. Overall, in the short and long term, the reform of this system is in any case a process that involves small steps; a path that can take place on roads that can run in parallel or perhaps in opposite directions and be contradictory, because progress is made of mistakes: trial and error, experimentation and error ” [p. 113-4].

Doing research without a patent: the example of the IRCCS Mario Negri

In the book, Garattini not only offers guidelines for a radical change in drug production policies – policies that are obviously in the hands of public decision-makers – but also recalls having put the fundamentals into practice. ethical principles who inspire them.

Indeed, the Institute for Pharmacological Research Mario Negri IRCCS has a purely anti-patent research perspective. On the institute’s website, the reason for the hostility towards patents is explained on a specific page: Because we do not patent our research? “. The answer is: “to be free”. Free from conflicts of interest, free to criticize, free to communicate, free to collaborate.

“Maintaining a research institution in constant balance between the need to find resources without giving up its freedom, dignity, critical thinking, is a difficult and complicated undertaking. Especially in Italy, where public funds are scarce and misused. It is therefore appropriate that public opinion learn to distinguish between those who care about personal interests and those who take care of the interests of the community, so as not to lack their support for the latter”.

The choice to renounce the patents not only reflects the famous precedents of Salk and Sabin, but also seems to find confirmation these days with the promise of a new anti-COVID-19 vaccine free of intellectual property: the CORBEVAX, the result of studies coordinated by Peter Hotez and Maria Elena Bottazzi for research part of Texas Children’s Hospital and Baylor College of Medicine.

CORBEVAX relies on a traditional technology – recombinant proteins – derived from research funded by very modest private donations. To be precise, it’s seven million dollars, a trifle compared to the billions in public funds raining down on Big Pharma for the production of mRNA vaccines.

The patent-free vaccine is an important model: it can be produced anywhere at low cost, easily stored and sold at low prices: it is estimated at $1.5/2 per dose. Moreover, it derives from a traditional technology, widely used for other vaccines and safe.

conclusion

The book ends with a dream: a future in which health can be separated from the market and from intellectual property.

The ultimate goal should be: “to achieve a more mature society with more ideals, in which medical and public health research should not be stimulated by profit, but rather by the recognition of public gratitude. This could be the time when medicine is no longer a “market”, but an organization at the service of those who suffer. […] Many readers may find this naive and a dream. Still, dream […] it’s still possible, and if we dream together, dreams can come true” [p. 125].

The pages of the volume deserve careful reading, especially by young people, because they represent the extraordinary testimony of those who, in 70 years of experience in the field of drug science, knew how to combine love of knowledge, sense of organization and dedication to people.

A message capable of to inspire those who have not given up hope that they can change the world for the better: starting with the realization of the fundamental rights to health and science.

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