UPSC, State PSC aspirants !, keep books aside on table (not very important for SSC IBPS) and be ready for one more topic. Recently you read/listen in newspaper/TV the landmark justice of SC, this drug company is denied to register patent, selling cancer drug, demanding a very high price and Also if you are really preparing for UPSC then you are aware about drug price control = Pranab Sen committee. So as usual, lets move with basics.
What is the Difference between Patents vs. Copyrights?
| Patent | Copyrights |
| Inventor/Designer has complete rights over the idea in whichever form it is used == right to exclude others from making, using, offering for sale or selling | Copyrights on the other hand given for a work in particular form like a book, an audio and only that exact reproduction, example cut and paste of text falls under its ambit. |
| It requires compulsory registration. | Does not require a registration, once the work is created it is a property of the author. |
| Patent rights are thus usually given for a brief period say 20 years. | The rights are given for the entire lifetime of the author and extend for 50 years even after the death of the producer. |
- a description of a machine could be copyrighted, but this would only prevent others from copying the description;
- it would not prevent others from writing a description of their own or from making and using the machine.
What is Pranab Sen Task Force on Drug Pricing
- In 2003 Supreme court passed an order that all essential drugs should remain under price control..
- Therefore, Government of India set up a Task Force under Dr. Pronab Sen on drug pricing.
- It submitted its final report in 2005.
- Then why the hell do we need to study it after 8 years? ans- It becomes an important [yearbook] topic for mains, due to the Glevac Patent Case, which has been in news recently. Crux is: Novartis company was refused the patent of Glevac (anti-cancer) drug in India and the SC said he was concerned with the extreme price of that drug.
Recommendations of Pranab Sen Task Force
Here are the major (and easy to remember) recommendations.How to regulate drug price?
- Pranab Sen says that No effort should be made to impose a uniform price,.
- only a ceiling price should be indicated.
- The ceiling price of essential drugs should normally not be based on cost of production but on readily monitorable market based benchmarks.
- The drug regulator must maintain a data base of brands and their compositions and no change should be permitted in the composition of a given brand.
- Price regulation should be on the basis of ‘Essentiality’ of the drug and it should be applied only to formulations and not to upstream products, such as bulk drugs.
- Drugs and Therapeutics (Regulation) Act (DATA) should be enacted for price control on drugs.
- Set up National Authority of Drugs and Therapeutics (NADT).
- Adopt the recommendations of the Mashelkar Committee 2003 i.e The Centre should financially support State Governments to bring their state drug control formations to a threshold level.
- All patented drugs and formulations should compulsorily be brought under price negotiation prior to the grant of marketing approval. (case CANCER DRUG;GLIVEC PATENT CASE; NOVARTIS;)
- Insurance companies should be encouraged to extend health insurance covering medicines.
- The role of PSUs producing drugs should be recognized.
- All Departments of Central Government must be advised to first procure their drugs from the PSUs at prices approved by NPPA
- There should be bulk purchases of drugs by Government agencies, cooperatives or consumer bodies through public-private partnership
- Central Government has set up a National Illness Assistance Fund (NIAF)= BPL patient is given financial assistance upto Rs.1.50 lakhs.
- Similarly State Governments should form State illness Funds (SIF)
- Increase the funding of Pharmaceutical Research and Development Support Fund (PRDSF).
- Reduce the excise duty on all pharmaceutical products from 16% to 8%.
- To create public awareness about drug pricing.
- positive use other possible modes of enhancing public awareness like public literatures, booklets, newsletters/magazines etc
ok. now let move to issue of Novartis = one more stone in already hard way of UPSC
What is Novartis?
- Novartis is a swiss pharma company.
- selling its drugs in India since 1947.
so what is the issue with Novartis ?
- Novartis was seeking Patent for a drug used to treat chronic Myeloid Leukaemia(CML), a type of blood cancer.
- The company’s price for its version of the drug, sold under the brand name of Glivec, is Rs 1,20,000 per month per person, but the generic version available in the market costs around Rs 8000- Rs 12000 Per Month. Hence, Novartis had applied for patent of the drug, to make the price more competitive and to stay in the business.
Timeline of Issue ?
- 1997- Novartis filed a patent application in India for its drug Glivec.
- 2005- India introduced the Indian Patent Act to prevent the evergreening or patenting of new forms of already known molecules.
- 2005- The patent controller in chennai denied Novartis the sought Patent.
- 2006- Novartis challenged the Indian govt and four other Companies in Madras Court.
- 2007- The Madras court ruled against Novartis’s Case.
- 2009- The intellectual Appellate Board rejected a fresh appeal.
- 2009- Novartis approached Supreme Court of India
- 2013- Supreme Court Denied the Patent
- April 2013- Again UPSC aspirants will have to prepare one more boring topic (hahaha). Don't waste time to mug-up dates/years.
What is Indian Patent Act ?
- Suppose you are going to patenting of new forms of already known molecules (drug) and if you (patent applicant) is unable to show significant enhancement in efficacy of its product then you are REJECTED.
What is the verdict of Supreme Court?
- The court said that the Patents (Amendment) Act, 2005 established that the ” mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not an invention for the purpose of Patenting.
- The bench dismissed the argument that the new form of drug is more soluble than the earlier saying that it does not pertain to increased efficacy of new form of drug.
- The court held that patents can be granted only for medicines that are truly new and innovative. For new forms and new uses of existing medicines, applicants of patent must prove increased efficiency.
Benefits from SC verdict ?
SC recognized the right of patients to access of affordable medicines.
SC recognized the right of patients to access of affordable medicines.
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