Europe's 'Database Right' Could Throttle Open Data Moves There

from the worse-than-useless dept

One of the more benighted moves by the European Union was the introduction of a special kind of copyright for databases in 1996: not for their contents, but for their compilation. This means that even if the contents are in the public domain, the database may not be. Thanks to a recent court judgment in France, this "database right" now threatens to become a real danger for the burgeoning open data movement in Europe (original in French).

The case concerns the site NotreFamille.com ("Our Family"), which wanted to obtain a copy of various public records held in digital form by the department of Vienne in France. These were things like parish records and census information for the 1600s, 1700s and 1800s -- all clearly in the public domain. But the region refused to make the digital versions of the records available, even though NotreFamille.com offered to pay, on the grounds that it had a separate database right in the digitized collection that enabled it to withhold what would otherwise be released as open data:

in order to justify an exclusive right to its database, the department of Vienne told the court it had "committed more than €230,000 [about $300,000] to this project and that the digitization of documents archive had taken eight years." This concerns a normal investment made in the context of the public service mission of the department, but it is sufficient, according to the court, to establish that the department is indeed a "database producer" with an exclusive right on the latter that allows it not to meet the requirement of open data.

That's really bad news, since it effectively guts the requirement to make public information freely available as open data, if held in a database that required some effort to put together, as is usually the case. Moreover, other courts in the European Union may well take a similar view, since the database right is Europe-wide.

This is galling because, unlike most copyright legislation, the database right law was followed up with some research commissioned by the EU in order to examine whether the premise -- that providing an additional intellectual monopoly on the database separate from its contents would stimulate extra investment by European publishers -- was in fact true. The evidence was pretty clear (pdf):

Introduced to stimulate the production of databases in Europe, the new instrument has had no proven impact on the production of databases. Data taken from the GDD (see Section 4.2.3) show that the EU database production in 2004 has fallen back to pre-Directive levels: the number of EU-based database "entries" into the GDD6 was 3095 in 2004 as compared to 3092 in 1998. In 2001, there were 4085 EU-based"entries" while in 2004 there were only 3095.

So this new monopoly turned out to be a complete flop. Worse, as the current case in Vienne shows, it is now starting to have negative effects on other initiatives. Clearly, the time has come to repeal this legislation before it starts to throttle a potentially important new area for growth in Europe.

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Filed Under: database rights, europe, open data

First Big Pharma Company Announces Support For Clinical Data Transparency Campaign: Who's Next?

from the saving-lives dept

It would be something of understatement to say that the spiralling cost of healthcare has become a highly-charged political issue in the US (and elsewhere). But wherever people stand on the funding of medicine, there is an implicit assumption that it works, and is worth even the exorbitant prices that pharmaceutical companies may charge. Sadly, that's often not true.

The reason is that drug approval is frequently based on partial or even misleading evidence from the crucially-important clinical trials that are conducted to check that a new treatment is safe and efficacious. Similarly, prescribing doctors often only have access to incomplete information when they are choosing drugs for a patient. Not knowing all the facts about medicines not only leads to a huge waste of money, since ineffectual or inappropriate drugs are sometimes prescribed, but can have life-threatening side effects. Here, for example, is a recent case involving the pharma giant GlaxoSmithKline (GSK) and its diabetes drug Avandia:

The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.

A scientist with the Food and Drug Administration estimated that Avandia could have been responsible for 100,000 heart attacks in the US.

The manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging side-effects of the drug, and there is evidence of the drug's harmful effects.

Here's why that critical data isn't always to hand:

companies and researchers can withhold the results of clinical trials even when asked for them. The best available evidence shows that about half of all clinical trials have never been published, and trials with negative results about a treatment are much more likely to be brushed under the carpet.

This is a serious problem for evidence based medicine because we need all the evidence about a treatment to understand its risks and benefits. If you tossed a coin 50 times, but only shared the outcome when it came up heads and you didn’t tell people how many times you had tossed it, you could make it look as if your coin always came up heads. This is very similar to the absurd situation that we permit in medicine, a situation that distorts the evidence and exposes patients to unnecessary risk that the wrong treatment may be prescribed.

That comes from a site called AllTrials (disclosure: I am on the advisory board of the Open Knowledge Foundation, which is one of the supporters of AllTrials). It has a very simple, but very ambitious aim:

The AllTrials initiative is campaigning for the publication of the results (that is, full clinical study reports) from all clinical trials -- past, present and future -- on all treatments currently being used.

If doctors have the full facts about all the drugs they can prescribe, they are in a better position to choose wisely. That will almost certainly save both money and lives. Despite that undeniable fact, pharmaceutical companies continue to withhold data from clinical trials, defying a US law that requires them to provide it:

Since 2008 in the US the FDA has required results of all trials to be posted within a year of completion of the trial. However an audit published in 2012 has shown that 80% of trials failed to comply with this law. Despite this fact, no fines have ever been issued for non-compliance.

Of course, it's not hard to see why drug companies don't want all that data out there: it would mean that independent analyses could be conducted, with the danger that they might come to very different conclusions about the efficacy and safety profile of the medicine in question. Against that background of the pharma industry's dogged refusal to cooperate in the opening up of clinical data, this announcement, from the same GSK discussed above, was unexpected:

GSK today further demonstrated its commitment to clinical trial transparency by announcing its support for the AllTrials campaign. The campaign is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports (CSRs) to help drive further scientific understanding.

Specifically:

GSK is committing to make CSRs publicly available through its clinical trials register. CSRs are formal study reports that provide more details on the design, methods and results of clinical trials and form the basis of submissions to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies. From now, GSK will publish CSRs for all of its medicines once they have been approved or discontinued from development and the results have been published. This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained.

In addition, while there are practical challenges, the company also intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require retrieval and examination of each historic CSR to remove confidential patient information. Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.

If GSK follows through on those promises, and really does provide all that data in a timely fashion, this is potentially huge. As Ben Goldacre, author of the book "Bad Pharma" about the betrayal of doctors and their patients by drug companies through the withholding of vital information, and a prime mover of the AllTrials campaign, explains:

The eccentric position is now not supporting alltrials.net. There is no serious defense for withholding information about clinical trials from doctors and patients. It is simply unethical, and it harms patients.

GSK's move is a breakthrough for the campaign because it negates arguments that it's simply not possible to provide detailed clinical trial information as a matter of course. This means that the pressure will be on the other pharmaceutical companies to follow suit -- or to give the impression they have something to hide about their products.

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Filed Under: alltrials, clinical trials, drugs, healthcare, open data, pharmaceuticals, secrecy
Companies: glaxosmithkline

Is Open Data A Boon Or A Bane?

from the keeping-things-in-perspective dept

Techdirt often writes about the benefits of openness and sharing. One area that is increasingly coming to the fore is open data -- for example, for some time both the US and UK have had major projects aimed at opening up the stores of data held by their respective governments, and other countries are rapidly joining the club. But amidst all the enthusiasm for such projects, it's easy to get swept away, and to accept the idea of open data uncritically. That's what makes this fascinating blog post entitled "Seeing Like a Geek" from Tom Slee so valuable, because he calls out what he sees as a serious problem with open data initiatives:

The point of this post is to draw attention to this open government data doppelgänger -- the shadow of commercial interests that follow civic hackers wherever they go; the new markets that spring up inevitably from the ruins of the old -- and to its dangers. I am suspicious of this doppelgänger: more so than most open data proponents, who tend to use the language of entrepreneurship and innovation when discussing companies who work with open data, and who contrast the new firms with the aging business models they seek to replace, and they often present commercial use as a complement to civic use.

His post gives some examples, such as the rich and powerful property developers using newly-digitized records to evict the poor from lands the latter had lived on for many years. More generally, he sees open data projects undermining traditional knowledge held in the memories of local people. Ultimately, he fears that open data may simply empower the empowered.

It's an important post, because it challenges many of the unacknowledged assumptions about open data and its worth. But as David Eaves points out in an equally insightful post written in response, Slee concentrates unduly on the negative aspects of open data, and omits mention of the problems of closed data:

There is, I would like to note, however no discussion about the cost of closed data -- or the powerful interests that mirror the open data free market doppelgänger's - that like to keep it that way. No acknowledgement for the enormous inequalities embedded in the status quo where government data is controlled by government agents -- and more often than not -- sold to those who can pay for it. I have no doubt that open data will create new winners and losers -- but let's not pretend like the status quo doesn't support many winners and create big losers either. Our starting point is not neutral.

The key point here is not that open data can't be abused by the unscrupulous, but that it is still better overall than what we have had until now, which is an entire system based on the exploitation of information asymmetries. Slee's concern that open data enthusiasts can be somewhat starry-eyed at times is a valid one, but Eaves is surely right that we must look at the broader context in order to understand the true value of openness and sharing.

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Filed Under: david eaves, open data, tom slee

Does Open Data Help The Rich Exploit The Poor?

from the sounds-a-little-alarmist dept

JNomics points us to a Marshall Kirkpatrick post on ReadWriteWeb about "How Open Data is Used Against the Poor," in which Kirkpatrick discusses an article and research about the effects of the digitization of land records in Bangalore. Apparently, as a result of the increased access to the data (for those with computers), middle and upper income people were able to exploit details found in the records as leverage for gaining land ownership from the poor.

Kirkpatrick and the author of the original article, Mike Gurstein, use this example to make the point that simply opening up data is often not really enough to benefit the broader population, and further, that it can simply promote the widening of the divide between the rich and the poor. Both argue for coupling open data with efforts that insure "effective use" for the most people - i.e., leveling the playing field by essentially controlling access to the data or delaying openness until tools and policies are put in place to insure equal footing for everyone. Kirkpatrick concludes his post with the following warning:

... if you want all parts of society to benefit from the opening of public data, then simply opening it up and allowing the most ferociously competitive people in society to grab a hold of it may not be a good way to impact the world positively.

This seems like a bit of an overstatement. There are always going to be those who are better positioned to take advantage of the opportunities presented by new technologies. An example from history would be the invention of the printing press. Of course the greater availability of books that followed initially provided a much bigger benefit to the educated than to the illiterate. However, not only were more people able to take advantage of cheaper, more abundant, books as literacy rates increased -- the abundance itself helped to drive that increase. Similarly, while this example from Bangalore shows that, initially, the more well connected have been able to take better advantage of the opening up of land record data, it is not difficult to imagine how the less fortunate will also benefit. The opening up of the data has exposed many problems with the records, allowing for the possibility that those issues will be addressed, and more care will be taken to guard against such issues in the future. Also, there will certainly be opportunities for some enterprising people among the poor to take advantage of the newly available data -- opportunities which did not exist at all when the information was effectively hidden. After all, the "ferociously competitive people" didn't actually "grab hold of" the data -- it's still open for access by anyone.

This case does demonstrate how the growing divide between the digital haves and have-nots is self-perpetuating, and it is certainly worthwhile to pursue efforts to close that gap by promoting education and the development of more widely available, cheaper technology. And efforts should be made to insure that access to open data is not abused by the better off to gain advantage over the poor. But in the end, the open data itself is not the culprit.

Filed Under: digital divide, open data, poor, rich

Should Public Transit Systems Open Up Their Data?

from the seems-like-a-good-idea dept

Should public transit data be opened up online for anyone to use? That's the question that's being discussed with regards to the Washington DC Metro's attempt to license its data to Google. Basically, Google has been asking the Metro to open its data up in an open format designed by Google, but which can be used by everyone, and which is quickly becoming the standard for transit info around the world. While the DC Metro has suggested a few objections, in the end it apparently has come down to money. The Metro wants Google to pay up for the data, noting that Google is a for-profit company and the DC Metro is a tax-payer and rider-funded public transportation system that could certainly use more revenue.

However, as others have pointed out, this seems short-sighted. First off, it's hard to come up with a sensible argument for why this data shouldn't already be made as accessible as possible -- especially since it is publicly funded. But, more importantly, by making the data available and letting others do the hard work of making it more useful it should drive more people to ride the Metro, meaning more revenue. Yet, in haggling over a license fee for the data, the Metro hoards the data, makes it more difficult to make that data useful and actually decreases ridership -- and likely overall revenue.

Filed Under: open data, public transit
Companies: google