COLOMBO (EconomyNext) – Sri Lanka’s doctors who prescribe drugs brands made by firms based in countries with stricter drug regulatory environments are likely to face a million rupee fine, from a new law to be enacted by legislators shortly, according to a report.
Though Western drugs – most of which are invented by people-owned firms based in Western countries such as the US, Britain or Switzerland – have a scientific or chemical name (generic name) they also have a brand given by which the producing company can be identified.
The brands may be given by either the original inventing firm (pioneer maker) or others who produce it under license or after patents have expired.
Sri Lanka’s ‘The Island’ newspaper quoted health minister Rajitha Senaratne as saying a draft bill to create a ‘National Medicinal Drug Regulatory Authority Act (MDRA)’ will be presented to the cabinet of ministers on February 06 and to the parliament later.
The drug law is a project of President Maithripala Sirisena, who claimed while campaigning that the draft law, brought when he was health minister, was blocked by the Rajapaksa administration allegedly after being bribed by drug firms.
Minister Senaratne was quoted as saying that a doctor who prescribes a drug by brand would be fined a million rupees.
The newspaper quoted All Ceylon Medical Officers’ Association (ACMOA) General Secretary Jayantha Bandara as saying that some provisions of the bill were welcome, without elaborating.
He was also quoted as saying that a National Drug Policy was not consistent with a policy by Senaka Bibile, a professor, which proposed absolute state control over drugs.
The intention of the promoters of the law is to stop doctors who are encouraged by pharmaceutical firms to prescribe their own brand, which may or may not be more expensive than another drug.
Critics however say generic drugs can be dangerous and doctors should have the freedom to prescribe the best drug that they know and even more importantly sick people should have the freedom to get a branded drug without being restricted by the state if they wished to do so.
Though drug firms based in South Asia and South America copy drugs originally produced after clinical trials by firms based in the West, usually known as ‘generics’ some doctors prescribe drugs by brand due to doubts about their actual efficacy.
A large number of new drugs are produced by citizen-owned companies in Western nations each year at a high regulatory cost. The cost of inventing, complying with regulations and bringing to market, a new drug could be about 2.5 billion US dollars (Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion) and 10 years, according to a study by the University of Boston.
Efficacy tests or clinical trials costs time and money. Many generic drug firms do not usually conduct them, and the regulatory requirements in the countries that they are based do not require them.
Many importing countries also do not conduct extensive tests as they are costly and requiring generic firms to do clinical studies for example will make the drugs much more expensive, defeating the objective of getting ‘cheap’ drugs.
As a result some doctors tend to prescribe drugs made by companies based in countries such as the US, which fall under the Food and Drug and Administration or firms coming under ambit of the European Medicines Agency or their subsidiaries in Asia or elsewhere.
Countries that want to keep costs of medicines low and assure quality simply ride on the regulatory regimes of such countries instead of duplicating the cost of regulation, and regulatory agencies at the expense of tax payers and patients.
Though generic drugs on which patents have expired may be chemically similar to the original drug, their production process, or the raw materials and catalysts used in their manufacture or the production process itself may not be the same, making their effectiveness variable.
Badly produced generics with inferior raw materials may also cause side effects or deaths.
Expensive packaging, made to control the temperature and light which can alter the chemical properties (stability of the active ingredient) may also affect effectiveness.
As a result all over the world, so-called ‘original’ drugs are sold and sick people pay higher prices to buy them voluntarily, despite the expiration of patents and the availability of generics, even when they are approved by regulators.
The US FDA, is now placing their officers inside South Asian drug firms who are selling in the US to make sure that the same standards that are followed in the US are also followed in India.
Original drugs were also more expensive because in their home countries they can be sued for damages, (A Damaging Decision on Generic Drugs) and regulators are closing loopholes. (FDA moves to make generic drug makers more accountable).
Generics in such jurisdictions are expected to be similar, and comply with a requirement known as ‘bioequivalence’ to a 90 percent confidence level, as well as safety ((The Biopharmaceutics Classification System: Highlights of the FDA’s Draft Guidance) and many generics work as well as the original or ‘pioneer’ drug. (FDA Ensures Equivalence of Generic Drugs).
But even FDA approved generics can be less effective than the original. (Generic Drugs: Dangerous Differences?)
Doctors who have doubts about the effectiveness of drugs after giving them to other patients earlier, sometimes play safe by prescribing what are known as ‘good’ drugs, either made by the pioneer firm or a so-called ‘reputed’ generics company with a track record.
Some doctors in Sri Lanka used to prescribe 500 mg strength tablets of a widely used antibiotic Amoxillin for example when it was a ‘generic’ and a 250mg tablets if it was by a well-known drug company based in Europe.
Patients who have prior experience with antibiotics are also known to ask for drugs by a brand that they know to have worked earlier having had bad results from generics such as finding that an acute cough turns to pleurisy after being treated by a generic.
After the new law is brought, only patients who are close friends of doctors or those with family relationships whom they feel that they will not complain to police and the rulers, may be able to get advice on ‘good’ or more effective drugs, some fear.
Freedom advocates say if the drug law has to be passed to satisfy interventionists it should have a provision where the patients who want to avoid any perceived risk of generics could request the doctor to prescribe a branded drug and indemnify him from any liability to fines.
This will give the freedom to patients to protect themselves from any risks from generics if they wished to do so.
But even now, nothing prevents patients from asking for a generic from a pharmacy if they wish to do so and pharmacies are quite happy to sell them.
Imposing price controls on drugs can also reduce their availability resulting in patients travelling longer distances to larger pharmacies to get drugs, or discourage the import of more expensive drugs.
Sri Lanka’s legislators have in the past taken away many freedoms of the people, to satisfy the desires of nationalists and interventionists, including language freedoms, the freedom to cheaper foods and even rule of law and justice.
However the current administration of President Maithripala Sirisena has promised to restore rule of law through reforms to the constitution including pro-freedom amendments that were overturned by the last regime.