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Tuesday, December 23, 2008

Research and chemicals, November, 2008

  1. Commission clashes with pharma groups over drug patents
  2. EU regulators say 'no' to embryonic stem cell patents
  3. Ministers outline EU research vision for 2020
  4. 'Safe levels' of chemical exposure under review
A rather fun one but in quite depressing way. Though I'm proud of the decision discussed in the second article. But only with that. Read my comments on the others to find out what depressed me. Though the main reason is actually the fact that people are so fond of lies, they cannot even consider talking the truth. It's very upsetting.

Commission clashes with pharma groups over drug patents

28 November 2008

The EU executive and European pharmaceutical giants engaged in a high-profile clash in Brussels today (28 November) as the European Commission produced a report on alleged breaches of competition by the industry.

Again, just days before the announcement of the preliminary results of the inquiry, new raids were conducted on the night of 24 November 2008 (EurActiv 26/11/08).

The Commission's preliminary report on the pharma sector inquiry, published on 28 November, alleges that "competition in this industry does not work as well as it should".

However, pharma industry federation EFPIA immediately shot back, ridiculing the Commission's "very selective use of facts" and claiming that the report "focused on the wrong issues".

The main findings of the report point to "problems" in how so-called "originator companies" that develop and sell new medicines delay market entry of cheap generics, blocking one another's innovation and thus the discovery of new drugs.

According to the report, originator companies are using "a variety of methods" with the objective of delaying or blocking market entry of generic companies to maintain high income streams for themselves. They also result in "significant additional costs for public health budgets – and ultimately taxpayers and patients," noted the EU executive.

The practices identified include:

  • Multiple patent applications for the same medicine (so-called patent clusters);
  • initiation of disputes and litigation;
  • conclusion of patent settlements which constrain market entry of generic companies, and;
  • interventions before national authorities when generic companies ask for regulatory approvals.

Higgins (Bayer) argued that the Commission had misunderstood the dynamics of the industry and overemphasised the issue of defensive patent strategies, which he described as a "red herring". "Patents only work if you have the right to defend them," he said.

Rather, he argued that the Commission should focus on the lack of competition in the generics sector: "Why do we pay more for our generics than US citizens?," he asked.

Higgins said he believed the Commission had been "overwhelmed by how much data we gave them" and asked the EU executive to focus on the facts. "This industry has nothing to hide," he concluded. source

My comment: This is fun. Especially the response they got from the "Industry". Oh, don't get me wrong, I agree with the Commission that there's something wrong with the way thing are, but that goes to the whole word, actually. /sorry, I'm a bit depressed today/ I'm absolutely sure that big companies abuse patent laws, I'm just not sure whose fault this is. Because patents as they are now, exist to be abused. How many independent patents you've seen on the whole European market? Well, I cannot speak with numbers, but if they were many, we wouldn't hear about stimulating Research so often. That's why I think that apart from pharmaceutical giants who obviously have to pay for their insolence, the result of those raid should be a rewriting of all the patent laws in the Union as one, single law that actually protects inventors. For a change.

EU regulators say 'no' to embryonic stem cell patents

28 November 2008

The European Patent Office (EPO) yesterday (27 November) ruled against allowing a patent on developing human stem cell cultures whose preparation involves the destruction of embryos. The decision may hamper stem cell research for commercial purposes, as companies may have little incentive to finance it without patent protection.

The EPO's appeal board confirmed an earlier decision regarding the use of stem cells filed by the US Wisconsin Alumni Research Foundation (WARF) in 1995. The EPO, however, stressed that their decision did not concern the general question of human stem cell patentability.

A 1998 EU directive clearly forbids patents on the industrial use of human embryos, yet industry has tried time and again to push them through. German Green MEP Hiltrud Breyer, who is also president of the European Parliament Bioethics Intergroup, "wholeheartedly" welcomed the "landmark ruling", saying that "human dignity has rightfully been put first".

She called on the European Patent Office to prohibit patents on stem cells, which cause the destruction of human embryos. "Such patents come at the expense of patients and doctors," she said, adding that patents should only allow technical use, not the gene itself.

WARF said it was considering various responses and stressed that the decision would not affect patent rights in the US. source

My comment: Ok, is it just me or it sounds weird to patent stem cells? No matter how you obtained, you still try to patent something that is existing without your will, something that you have not created. For me, it's clear - in the case, you should be able to patent only processes, nothing more. Because if you patent stem cells, what is the next step, the mother to pay for the stem cells in the baby's cord? This is absurd and very dangerous!

Ministers outline EU research vision for 2020

3 December 2008

Amid fears that the current economic crisis could severely hamper R&D investment, EU research ministers yesterday (2 December) unveiled their bold vision of a borderless European Research Area (ERA) by 2020 to boost the bloc's competitiveness.

Maintaining R&D investment and strengthening the "knowledge triangle" of education, research and innovation are key to the successful completion of the ERA, ministers said.

Addressing fears that research budgets may be cut during the current crisis, the commissioner said investing in R&D and innovation was "not a supplementary burden but an indispensable investment in future jobs and growth".

Ministers also agreed on a procedure for joint research programmes, aimed at better responding to major societal challenges such as the food crisis and its consequences for agriculture, as well as how to manage our ecosystem, climate change or the ageing of the European population.source

My comment: Yeah, I couldn't agree with this more. Actually, I can say even more, but I think I already said it in few occasions. If the EC is smart, it will bet on the R&D. This is the only way to get clean of what is to come. Industries are going to drown, but technology and technological supremacy will stay on top and whoever has it, will be on the top after the crisis is over. I hope they realise it rather sooner than later.

'Safe levels' of chemical exposure under review

1 December 2008

A draft report by three EU scientific committees tries to establish whether current toxicity risk assessment can be applied to establish safe levels of human exposure to a number of substances in cosmetics, toys and cleaning products. Its initial findings can be commented upon until 2 January 2009.

The draft report , published in November, comes just days before a 30 December deadline to pre-register substances for safety screening and registration under the EU's chemical regulation REACH.

The report assess the applicability of the so-called Threshold of Toxicological Concern (TTC) approach to the human health-related risk assessment of chemical substances.

The TTC concept is based on 'safe levels of of exposure' and evaluates toxicity based on substances' known toxicity or chemicals that share similar characteristics. According to the EU scientific committees, it is used in situations where there is limited or no information on the toxicity of a compound, and where human exposure is so low that adverse effects are not expected.

The concept is currently used for materials which come into contact with food, but its application in a number of other areas is under discussion, notes the report, listing consumer products, food additives, pesticides and cosmetics as examples.

The draft opinion underlines that appropriate exposure assessment is essential for TTC, adding that only limited knowledge exists regarding a wide variety of consumer products with "complex exposure scenarios" and "multiple exposure routes".

The scientific committees note that "uncertainties are higher and methodology is less developed" for consumer products such as cleaning products, cosmetics and toys, which involve oral exposure, skin contact and exposure via inhalation. Meanwhile, "significant" exposure is likely for products that are frequently used, they add.

In conclusion, the committees call for further research to be carried out into the development and validation of toxicity databases, particularly in areas where insufficient numbers of representative chemicals are included.

With regard to exposure, the document states that, for human health aspects, the TTC approach is only applicable in cases where detailed information is available on all anticipated use scenarios for which the risk assessment is provided. source

My comment: What a useless piece of research. Really. Seriously, what new information we got out of it? That we cannot make risk assessment based on TTC approach for complex situations. Well, hello! I think they (or maybe I) got the whole idea wrongly - the point was to check if the presence of a single toxic element can lead to disqualifying of a product. And the answer here should be pretty straight forward as long as the product is in the form that is toxic to humans. Unfortunately, they simply couldn't but a "No" in a way that the industry won't have to hang them somewhere. Oh, well, nothing new here...

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