RTI and clinical trials

Sarah Hiddleton has a useful note today in the Hindu about the Right to Information and Clinical trials in which she discusses how disclosure of test data is in the public interest. This is against the backdrop of the Mahyco/Greenpeace fight over Bt Brinjal test data currently being fought in the Delhi High Court. Some useful international comparisons in the article which make it a compelling read.

The question therefore is this: when does public interest in trial data outweigh commercial interest?

If the researchers had not gone to such lengths to obtain full data from the U.S. Food and Drug Administration (FDA) under the freedom of information act, we would never have known that published data available to the scientific community had not included significant information from unfavourable trials (nine of these were refused by the FDA, data from four of them were obtained from a company website). We would have also been ignorant of the fact that the FDA had not spotted data manipulations from which conclusions were drawn and approved the drug on that basis. Nor would we have known that the companies involved had breached the trust of those who underwent the trials, the doctors who prescribed the medicines, and the patients who took them. Nor that these companies have made massive profits for something that has not stood up in the trials.

What if a product was found not just to be ineffective, but harmful? Just 10 days after Kirsch’s results were published, GlaxoSmithKline was found to have withheld clinical trial data from the United Kingdom regulator, the Medicines and Healthcare Regulatory Authority (MHRA), that showed that its anti depressant increased the risk of suicide among teenagers, and that it had known this since 1998.

Does putting such data in the public domain affect a company’s commercial interest: Yes. But does the public interest outweigh this? Yes, because if the product is useless or harmful, there should be no commerce in it in the first place.

Companies claiming that this might affect their intellectual property would do well to remember that this is at the core of the a defined set of criteria through which society gives up its fundamental immediate right to health to grant a right to property. A patent, which gives a company a monopoly in recognition of the risks it undertakes in product development, is awarded if a product is new, involves an inventive step, and has an industrial application – in other words if it is useful.

A very long time ago, I wrote this article on Data Protection that has since been quoted somewhat widely. Has some useful information on clinical trials, although my position is opposite to what is stated in the article.

GI registration for crop varieties

The Hindu reports today that the Karnataka Government is seeking GI registratino for 21 crops in addition to 9 crops that it has already registered.

The crops for which the Geographical Indication tag is sought are: Byadagi Chilli, Devanahalli Chakkota, Kamalapura Red Banana, Sagar Appe Midi Mango, Mattu Gulla Brinjal, Bangalore Rose Onion, Totapuri Mango, Bangalore Blue Grapes and Janagere Jackfruit.

Why?

Mr. Ganeshan said the Horticulture Department wanted to create a brand value to the unique crops of the State through GI registration. This would go a long way in getting remunerative prices to farmers, especially in the international market, he said.

What else?

Karnataka is leading other States in getting GI tags for its crops as six out of the 10 crops in the country for which GI tag has been provided are from the State.

Like a race.

See my previous post and Icommons article on Cultural and Biological Heritage and IP.

DoT issues 15 day ultimatum to Blackberry service providers

The Blackberry controversy drags on with the DoT issuing a fifteen day ultimatum to telecom companies to put in place a suitable wiretapping system. The Business Standard article linked to above suggests that before Tata, other operators may not have specifically applied for and obtained a license to specifically introduce Blackberry devices.

The Blackberry service corresponds to the description of a Unified Messaging System – the license for which bars bulk encryption without placing a specific limit of 40 bits or otherwise. (However, UMS providers are required to obtain an ISP license as well, and so the 40 bit restriction is inherited). The DoT website has a list of UMS licensees which does not include any of the Blackberry providers.

What is a UMS?
“UMS shall have the ability to record, send and process Voice, Fax and E-Mail messages of subscribers. The terms “Message” in the document shall collectively indicate Voice, Fax and E-mail unless otherwise indicate. The system shall consist of Voice Processing sub-system, Storage sub-system (for voice, fax and e-mail), and Network Interfaces and Maintenance sub-system.

The objective of UMS is to allow subscribers to send, retrieve and manage messages in a uniform way, regardless of whether the message is a voice mail, a fax mail or an e-mail. In addition it shall be possible to manage the messages from various terminal types including phones, web browsers, standard e-mail clients and WAP terminals.”

I think this controversy has more to do with the existence of bulk/block encryption itself at a network-wide level, rather than at the individual user leve. Bulk encryption is forbidden for use by the “Licensee” under both the ISP and the UMS licenses. Individuals are given some relaxation on this rule and permitted to use encryption not-exceeding 40 bits and they may apply for a relaxation of this rule. However, ISPs themselves are not permitted any leeway and no mechanism exists even to apply for a relaxation.

So what’s going to happen?

DTH interoperability

Article in the Business Standard today about interoperability of DTH receivers.

The interoperability clause in the DTH licensing norms makes it mandatory for all DTH service providers to offer a technically compatible DTH set-top box so that the consumers can easily shift their operator without changing their set-top box.

However, due to difference in technology between Dish TV, Tata Sky (MPEG-2) and the latest technology of new entrants, existing DTH subscribers cannot access the services offered by the new players on their existing DTH boxes.

The TRAI had requested the Bureau of Indian Standards (BIS) to develop standards of interoperability due to a plurality of formats being used by operators.

The BIS has been requested by the Telecom Regulatory Authority of India (Trai), to make recommendations on standards of DTH boxes. A transcoder will cost the new DTH companies about $10-15 (30-40 per cent of the DTH hardware cost).

“A transcoder will help the consumers shift to the DTH services of as many operators as they want. It’s like a mobile consumer shifting from one service provider to another without changing his mobile handset,” said a member of the BIS technical committee.

According to sources, the BIS decided to delegate the responsibility for preparing a detailed paper on interoperability of DTH boxes to its members amid opposition from Tata Sky — Sky opposed this move on the grounds that the Ministry of Information and Broadcasting (I&B) is the deciding body on interoperability and the BIS should not act in the matter till the ministry takes a decision.

While both Dish TV and Tata Sky are using MPEG-2 compression technology, the new DTH entrants are using MPEG-4 technology.

Through MPEG-4 technology, the DTH companies can offer 25 per cent more channels per transponder (a device fitted on the satellite through which DTH transmission takes place) than those using MPEG-2 technology.

NPPA asks Cipla to refund `overcharges`

WHAT?!
I need to look at this Supreme Court order now.

The National Pharmaceutical Pricing Authority (NPPA) has asked leading drug-maker Cipla to pay Rs 62.85 crore as interest on alleged unpaid overcharged amounts in respect of drugs Ciprofloxacin, Norfloxacin, Salbutamol and Theophylline.

The NPPA also made a fresh demand of Rs 4.12 crore as alleged overcharged amounts inclusive of interest in respect of Doxycycline and additional packs of Norfloxacin.Cipla, informing the Bombay Stock Exchange today, said the demand was contrary to the orders of the Supreme Court and the company had received legal advice that entire amount demanded by the government was not tenable and sustainable.