The recent ruling by the Supreme Court in India that a Swiss pharmaceutical company cannot 'patent' a medicine used to treat a rare form of leukemia - has generated much debate on the thorny issue of 'brand' and 'generic' drugs.
Drug manufacturers spend upwards of 60 million US dollars to bring a new drug to market (through animal studies, Phase I study in humans for drug toxicity, Phase II study for drug safety and efficacy in persons affected by the disease, Phase III study for effectiveness, safety and appropriate dosing, and Phase IV - post market continued surveillance). In return, they request patenting protection for them to attempt to 'make back' their money invested in the drug over a specified period (e.g. 10- or 15-year patent).
However, in countries of the South (less developed countries), the cost of these drugs can be very prohibitive, and the matter can be particularly perplexing when the particular disease to be treated is pervasive in the local population with much morbidity and mortality (as with effective treatment for HIV/AIDS). To save lives, many would opt to 'breach the rules of patenting' and suffer the consequences. Whilst some pharmaceutical companies have provided discounted drugs to some 'low income' countries, not all companies have the same approach and are not required by any local or international guideline or treaty to do so.
Patenting, Or Is It Really?
At one end of that spectrum on patenting - some pharmaceutical companies have been 'stretching' the notion of patency by 'tweaking' one or two 'molecules' of their patented drug close to the time when such patency is due to expire - to produce what they call a 'new' drug. They then apply to, for example, the U.S. Food and Drug Administration (FDA) for a patent on this 'new' formulation, and if granted - they continue to hold monopoly on the production of this valuable drug.
The Indian Supreme Court ruled that Glivec, the drug developed by Novartis, was not different enough from drugs already on the market, quoting an Indian law that sets stiff requirements for patenting new medicines. Novartis had argued that putting the chemical compound in a crystalline form was a 'breakthrough'. Activists and aid groups heralded this decision as a crucial victory for impoverished patients worldwide who rely on India for affordable generic medicines. Generics can be produced legally only after 'patents' expire. If the Indian Court had allowed the Glivec patent, it would have paved the way for patenting many other drugs, including those widely used for treating HIV/AIDS and other devastating illnesses, which are currently being produced cheaply in India as generics.
Novartis had also argued that the drug had already been patented in China, Russia, and a dozen other countries, and that such protection helps encourage investments in new medicines. It subsequently commented that this ruling was a set-back for patients, as it will hinder medical progress for diseases that lack effective treatment options, and it will be 'cautious' with its future investments in drug development in India. The US Chamber of Commerce also adopted a similar position, stating the decision would hinder businesses from investing in medical and technological advancements, especially in the pharmaceutical and medical sectors.
In other countries, Glivec costs roughly US$2,600 a month, compared to less than US$200 monthly for the generic versions available in India. Novartis however says it already provides Glivec for free to 95% of Indian patients who need it. If this is true however, it begs the question - why would Novartis want to block its generic production in India, unless it is to block the sale of the generics to other countries!
The battle on generic drugs now moves to the Pacific free trade agreement currently under negotiation among a number of countries - including the USA, Canada, Mexico, Vietnam, and Malaysia. In light of the Indian Supreme Court ruling, this agreement could seek to set a lower bar for patenting medicines, thereby mitigating the effect of the Indian Court decision, and making it much harder for aid and other groups to use generics to treat patients in countries that join the free trade agreement pact.
Other sides to the issue of brand versus generic drugs exist. Some of the earlier generic drugs that came out in the 1980’s were distinctly not as efficacious as the 'brand name' drugs. This perception has persisted to this day, and tarnishes the name and reputation of the very good 'generic' drugs. One 'brush' is used to 'paint' all generic drugs, and many pharmaceutical companies 'push' this approach in their marketing strategies. Further, in the 'detailing' of their products to medical professionals for their prescribing to patients, many companies provide undue inducements to doctors to prescribe their particular product over others. Ethically, doctors should only be influenced by the greater benefit that a particular drug (compared to others) will provide to his or her patients (whether by way of treatment or cost-savings). The incentives provided by some drug companies provide unethical inducements for doctors' habits.
In one of my bi-weekly blogs on the internet, I posed this question to readers: “Would you have a different perception if you found out that your doctor was influenced by a pharmaceutical company to prescribe its product over that of another company? Would your view regarding the doctor change? Would your view change in regard to the medication?
Selling or Prescribing??
In order to sell their products, drug companies need to promote them and doctors need to prescribe them. In theory – doctors are supposed to make individual prescribing decisions based sole on the needs of their patients. However, this issue is not that easy, as there is no completely objective neutral decision-making process that is free from any kind of influence at all! Some persons maintain that the influence sought by drug companies and the overt promotions done are likely to ‘stick’ in the doctor’s mind. Whether this translates to affecting the doctor’s prescribing habit however, is a ‘moot’ point.
Some drug companies’ representatives present great treats of appreciation to doctors, and some drug companies pay for meals at dinner meetings, and even pay travel expenses for some doctors’ attendance at meetings and conferences overseas. In certain countries, drug companies pay doctors millions of dollars each year to speak positively regarding their product, while others are paid for research, and some for consulting. Whilst the latter involvement is important in the development of new product, if these doctors also provide treatment for patients, some view such involvement as a conflict of interest. The belief is that doctors are invariably influenced in the process.
Consequently, in societies where patients have ‘power’ based on a high respect for autonomy (which rarely exists in countries of the South), patients being cared for in a ‘one-on-one’ setting (private health care) are encouraged to ask their doctors specifically if they have any relationship with drug companies, and if so – what is the relationship and whether there is another option to the product being prescribed. Such questions will cause both the doctor and the patient to reflect on what are the right reasons for making treatment decisions.
In the public sector setting, particularly in countries of the South with very limited resources, health care professionals should be encouraged to develop cost-consciousness and the appropriate stewardship of resources. Considerations of cost-awareness and risk-benefit analysis are appropriate. These include avoiding the overuse or misuse of diagnostic tests and treatments that do not benefit direct care, but add to health care costs.
Do What Is Ethically Right
Doctors should actively consider the possible use of generic drugs and not write brand name drugs simply out of habit. Each brand name product should be judged on its own merit, and appropriate research should be done to ascertain whether its generic equivalent is just as efficacious. In my CME presentations to doctors, I have often posed the question: If a brand name drug is considered to be slightly better – but the generic equivalent is one-half the cost – which would you choose to prescribe?
Where patients directly purchase their medications, it is my view that doctors should always consider the patient’s ‘pocket’ each time they write a prescription, and give the patient the choice whenever in doubt whether to write a ‘brand’ or generic drug. Generic substitution of ‘bio-equivalent’ formulations of the same drug can result in substantial savings to patients, their families, and public health care systems!
Dr. Derrick Aarons graduated from Kingston College in 1972, and served as Deputy-Headboy in his final year. Dr. Aarons is a consultant bioethicist, palliative care and family physician providing specialist advice in ethical issues in Jamaica and the Caribbean, and is a member of the Executive Council of RedBioetica UNESCO.