Patent – WMA – The World Medical Association

Adopted by the 73^rd WMA General Assembly, Berlin, Germany, October 2022

PREAMBLE

SARS-COV-2 Pandemic caused more than 400 million cases and nearly 6 million deaths. It is quite comforting that vaccines that ensure protection from the disease have been produced, and data relating to the course of the pandemic in countries with high vaccination coverage is promising. 62.3% of the world population has received at least one dose of a COVID-19 vaccine. Only 11.4% of people in low-income countries have received at least one dose. Deep inequalities in access to vaccines are still observed globally and failure to achieve collective immunity leads to the -further spread of new, more contagious and immunity-evading variants of the disease through mutation. Worldwide application of vaccines is of critical importance in terminating the Covid-19 pandemic. Every minute of delay in vaccinations means further spread of the disease at global scale and more lives lost. It is not sufficient to immunize all citizens in any given country; immunization has to reach a sufficient level in the world as a whole to effectively combat and control the pandemic.

RECOMMENDATIONS

The WMA urges all parties to:

1.Remove barriers to promote equity of access to COVID-19 vaccines that are globally proven to be safe and effective;

2. Work with governmental and appropriate regulatory bodies to encourage prioritization of equity when providing COVID-19 pandemic-related resources such as diagnostics, free medications, therapeutics, vaccines, raw materials for vaccine production, personal protective equipment, and/or financial support, and guarantee universal accessibility and free distribution;

3. Establish vaccination strategies that consider the specific peculiarities, challenges and vulnerabilities of each region, prioritising the most vulnerable people, including health professionals;

4. Insist on the importance of vaccination and take action to achieve maximum coverage and protect the population in need;

In this context,

5. Confront vaccine hesitancy by providing evidence-based guidance on the safety and necessity of vaccines;

6. Share of knowledge required for vaccine production to the COVID-19 Technology Access Pool created by WHO to ensure that vaccines are produced at as many centres as possible and sharing of this knowledge;

7. Allocate public funds to improve the capacity of vaccine production centres and increase the channels of safe distribution so as to ensure fair access, to provide equitable and efficient vaccine supply and distribution;

8. Design national vaccine programmes that take into account a global analysis rather than only national considerations;

9. Promote sustainable solutions to patent issues. This may include the temporary lifting of patents on COVID-19 vaccines under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and similar agreements to promote equity of access in global emergency situations, while ensuring fair compensation for the intellectual property of the patent holders if asked, global investment in manufacturing sites, training of personnel, quality control, and the transfer of knowledge, technology and manufacturing expertise;

10. Support WHO efforts and initiatives to increase production and distribution of therapeutics and vaccines necessary to combat COVID-19 and future pandemics in order to provide vaccine doses to low and middle-income countries with limited access, including:

technological transfers relevant for vaccine production;
other support, financial and otherwise, necessary to scale up global vaccine manufacturing; and
measures that ensure the safety and efficacy of products manufactured by such means.

11. Call on governments and the United Nations to take all necessary measures to facilitate equitable access to vaccines throughout the world by supporting and promoting the sharing of all vaccine-related processes for combating pandemics (R&D, patenting, production, licensing, procurement and application).

Adopted by the 69^th WMA General Assembly, Reykjavik, Iceland, October 2018

PREAMBLE

The expiry of patents for original biotherapeutics has led to the development and approval of copies, called ‘similar biological medicinal products’ or ‘biosimilars’ that are highly similar to a previously approved biological product, known as the originator or reference product.
In light of the fact that biosimilars are made in living organisms, there may be some minor differences from the reference medicine, as minor variability is a characteristic attribute of all biological medicines. The manufacture of biosimilars is generally more complex than the manufacture of chemically derived molecules. Therefore, the active substance in the final biosimilar can have an inherent degree of minor variability. Innovator biologics also have inherent batch-to-batch variability, and for that reason biosimilars are not always interchangeable with the reference products, even after regulatory approval.
Biosimilars are not the same as generics. A generic drug is an identical copy of a currently licenced pharmaceutical product that has an expired patent protection and must contain the ‘same active ingredients as the original formulation’. A biosimilar is a different product with a similar, but not identical, structure that elicits a similar clinical response. As a result, biosimilar medicines have the potential to cause an unwanted immune response. Whereas generics are interchangeable, biosimilars are not always interchangeable.
Biosimilars have been available in Europe for almost a decade following their approval by the European Medicines Agency (EMA) in 2005. The first biosimilar was approved by the Food and Drug Administration (FDA) for use in the United States in 2015.
Biosimilar medicines have transformed the outlook for patients with chronic and debilitating conditions, as it is possible to obtain similar efficacy as that of the reference product at a lower cost.
Biosimilars will also increase availability for patients without access to the bio-originator. Greater global access to effective biopharmaceuticals can reduce disability, morbidity, and mortality associated with various chronic diseases.
Nonetheless, the potentially lower cost of biosimilars raises the risk that insurers and health care providers may favor them over the originator product, even when they may not be appropriate for an individual patient or in situations when they have not demonstrated adequate clinical equivalence to an original biological product. The decision to prescribe biosimilars or to switch patients from reference medicine to a biosimilar must be made by the attending physicians, not by health insurance companies.

RECOMMENDATIONS

National medical associations should work with their governments to develop national guidance on safety of biosimilars.
National medical associations should advocate for delivering biosimilar therapies that are as safe and effective as their reference products.
National medical associations should strive to ensure that physician autonomy is preserved in directing which biologic product is dispensed.
Where appropriate, national medical associations should lobby against allowing insurers and health funds to require biosimilar and originator product’s interchangeability, and for safe regulations of interchanging biosimilar medicines where this is allowed.
Physicians must ensure that patient medical records accurately reflect the biosimilar medicine that is being prescribed and taken.
Physicians shouldn’t prescribe a biosimilar to patients already showing success with the originator product, unless clinical equivalence has been clearly demonstrated and established and patients are adequately informed and have given consent. There should be no substitution between biosimilars and other drugs without the attending physcian’s permission.
Physicians should seek to improve their understanding of the distinctions between biosimilar products that are highly similar to or are interchangeable with an originator product; raise awareness of the issues surrounding biosimilars and interchangeability; and promote clearly delineated labelling of biosimilar products.
Physicians should remain vigilant and report to the manufacturer, as well as through the designated regulatory pathways, any adverse events suffered by patients using originator biological products or biosimilars.

Adopted by the 51^st World Medical Assembly, Tel Aviv, Israel, October 1999,
revised by the 60^th WMA General Assembly, New Delhi, India, October 2009
and reaffirmed by the 212^th WMA Council Session, Santiago, Chile, April 2019

PREAMBLE

1. Under the law of some jurisdictions medical procedures are patentable. Patents on medical procedures are often called medical procedure patents. A medical procedure patent or patent claim is one that only confers rights over procedural steps and does not confer rights over any new devices.

2. Over 80 countries prohibit medical procedure patents. The practice of excluding medical procedures from patentability is consistent with the Uruguay Round of Amendments to the General Agreements on Tariffs and Trade Agreement on Trade Related Aspects of International Property Rights (GATT-TRIPs), which states: “Members may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals” (Article 27).

3. The purpose of patents is to encourage private investment in research and development. However, physicians, particularly those who work in research institutions, already have incentives to innovate and improve their skills. These incentives include professional reputation, professional advancement, and ethical and legal obligations to provide competent medical care (International Code of Medical Ethics, 17.A). Physicians are already paid for these activities, and public funding is sometimes available for medical research. The argument that patents are necessary to spur invention of medical procedures, and that without procedure there would be fewer beneficial medical procedures for patients, is not particularly persuasive when these other incentives and financing mechanisms are available.

4. Another argument is that patents are necessary, not so much for invention but for product development. This argument also is not persuasive in the case of medical procedure patents. Unlike device development, which requires investment in engineers, production processes, and factories, development of medical procedures consists of physicians attaining and perfecting manual and intellectual skills. As discussed above, physicians already have both obligations to engage in these professional activities as well as rewards for doing so.

5. Whether or not it is ethical to patent medical devices does not bear directly on whether it is ethical for physicians to patent medical procedures. Devices are manufactured and disseminated by companies, whereas medical procedures are “produced and disseminated” by physicians. Physicians have ethical or legal obligations to patients and professional obligations towards each other, which companies do not have. Having particular ethical obligations is part of what defines medicine as a profession.

7. There is no a priori reason to believe that those holding medical procedure patents would make patented medical procedures widely available. Patentees might attempt to maximize their profits by making the procedure widely available through nonexclusive licensing with low fees. Alternatively, they might attempt to maximize profits by limiting availability of the procedure and charging higher prices to those for whom the procedure is extremely important and who have the means to pay.

8. Competition between organizations providing health care could provide incentives for some organizations to negotiate exclusive licenses, or licenses which sharply limit who else could practice the procedure. Such a license might provide the organization with an advantage in attracting patients, if the organization could advertise that it was the only organization in a region which could provide a particularly desirable service. Thus, at least some of the time patentees will probably limit access to patented medical procedures.

9. Medical procedure patents may negatively affect patient care. If medical procedure patents are obtained, then patients’ access to necessary medical treatments might diminish and thereby undermine the quality of medical care. Access could diminish for the following reasons:

the cost of medical practice would likely increase because of licensing and royalty fees, and because the cost of physicians’ insurance would likely increase to cover patent litigation expenses.
some physicians capable of performing the patented procedure might not obtain licenses to perform it. The number of licensed physicians might be restricted because certain physicians cannot or will not pay the licensing fees or royalties, or because the patentee refuses to make the license widely available. Limiting the number of licenses would, in some circumstances, limit patients’ choice of physicians.
The presence of patents may prevent physicians from undertaking even those procedures which do not infringe. It may also deter a physician from introducing new or modified procedures into his or her practice. Devices can be labelled if they are patented, but procedures cannot, and therefore it is not immediately obvious whether what one is doing infringes somebody else’s medical procedure patent. However, lack of knowledge is no defence against patent infringement, so if a physician is uncertain he or she may simply refrain from performing the procedure.

10. Enforcement of medical procedure patents can also result in invasion of patients’ privacy or in the undermining of physicians’ ethical obligation to maintain the confidentiality of patients’ medical information. Where physicians practice in small groups or as sole practitioners, the most expedient methods for a patentee to identify instances of infringement might be to look through patients’ medical records or to interview patients. Removing obvious identifiers for the record review would not guarantee confidentiality, because identity can often be “reconstructed” with very few pieces of information. This would be particularly true in small towns or small practices.

11. Physicians have ethical obligations both to teach skills and techniques to their colleagues, and to continuously learn and update their own skills. Medical procedure patents can undermine these obligations. Once a patent has issued on a procedure, the procedure would be fully disclosed (this is one requirement for obtaining a patent); however, those without licenses would not be able to practice it. Limiting who can practice the procedure undermines the spirit of the ethical mandate to teach and disseminate knowledge. It also undermines the obligation to update one’s skills, because it does not do much good to acquire skills which cannot be used legally.

12. The obligation to teach and impart skills may also be impaired if the possibility of patents causes physicians to delay publishing new results or presenting them at conferences. Physicians may be inclined to keep new techniques secret while waiting to complete a patent application. This is because public use of a procedure, or publication of a description of the procedure, prior to applying for a patent may invalidate the application.

13. Physicians also have an ethical obligation not to permit profit motives to influence their free and independent medical judgment (International Code of Medical Ethics, 17.A). For physicians to pursue, obtain, or enforce medical procedure patents could violate this requirement. Physicians holding patents or licenses for procedures might advocate for the use of those procedures even when they are not indicated, or not the best procedure under the circumstances. Physicians who are not licensed to perform a particular procedure might advocate against that procedure, even when it is the best procedure under the circumstances.

14. Finally, physicians’ professional obligations to practice their profession with conscience and dignity (Declaration of Geneva) might be violated by the enforcement of medical procedure patents. The spectacle of physicians suing each other on a regular basis is unlikely to enhance the standing of the profession.

POSITION

15. The World Medical Association

states that physicians have an ethical responsibility to make relevant scientific information available to colleagues and the public, when possible.
states that the patenting of medical procedures poses serious risks to the effective practice of medicine by potentially limiting the availability of new procedures to patients.
considers that the patenting of medical procedures is unethical and contrary to the values of the medical profession that should guide physicians’ service to their patients and relations with their colleagues.
encourages national medical associations to make every effort to protect physicians’ incentives to advance medical knowledge and develop new medical procedures.