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EU perspective on Nanomedicine

Friday, February 2, 2007

Olivier Van Droogenbroek referred me to the latest EGE (European Groups on Ethics in Science and New Technologies) activity: its adoption of the 21 st Opinion on the ethical aspects of Nanomedicine. The document is downloadable here.

Here's an excerpt on what they think, the hardest challenge to laws and regulations will be:
  1. the risk evaluation for nanomedicine may not be adequate in all areas;
  2. the implementation of risk evaluation measures should be carried out in a scientifically sound and transparent manner;
  3. there is a need for legal clarity in a number of areas especially where regulations and/or areas overlap;
  4. ethical dimensions must be taken into account in legal provisions
  5. on nanomedicine.
I have not look this document throughly. I found however, some interesting remarks on human enhancement, intellectual property and data protection as a result of the use of nanomedicine.

I will discuss the topics more detail in my later posts.

(H.T. Olivier Van Droogenbroek)

 

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Update on Berkeley Nanotech Regulations

This is to update my analysis on Berkeley Nanotechnology Regulations in the previous post. On the December 2006 post, I suggested this interpretation:
  1. The duty is to report, no more, no less
  2. There are no exact standard as to the form of the report
  3. General minimum disclosure standards may apply. Producers shall disclose anything within the boundaries of their present knowledge. Non disclosure may arise civil liability
  4. It only applies to "manufactured" nanoparticles produced in the Jurisdiction of the city of Berkeley. That means, natural nanoparticle or nanoparticle resulting from side-reaction could be exempted from this regulation. This could also mean that nanoparticles being imported to Berkeley is outside the scope of this regulation
  5. The city cannot ban production and sale of nanoparticles by simply basing itself on the regulation. These are EPA's authority
  6. The regulation does not regulate nanotechnology as a whole! It only regulates nanoparticle. Obviously, nanostructures are exempted from this regulation
  7. There could be problems with regards to the definition of "nanoparticle"
With regards to point #2, I have obtained information that the standard reporting forms are currently being reviewed by industry and other stakeholders. So there might be a standard form of reporting. With regards to point #3, the report might need to be reviewed by an independent third party, a professional toxicologist or CIH, and this constitute a part of the reporting form. My interpretation is inaccurate with regards to point #4. Importation of nanoparticle to Berkeley will be subjected to the reporting obligation. With regards to point #6, nanostructures may be subjected to reporting obligation if one of their axis is 100 NM or smaller (fit the definition of "nanoparticle").

Preliminary observation on the regulation will be based on this report (pdf).

I agree with Mr. Hadithy that these precautionary approaches are required to protect the society from unknown harm. There is really nothing unusual with respect to the regulation, it is no different than normal chemical legislation which also require disclosure. The only differences is that this one is applied to nanoparticles. As have been discussed in my other posts, there is inconclusive research result on the harmful effect of nanoparticles to human.

Cambridge is also planning to follow Berkely in regulating Nanotechnology:
COUNCILLOR DAVIS
WHEREAS: The use of subatomic materials as microscopic building blocks for thousands of consumer products has turned into a big business so quickly that few are monitoring nanotechnology’s effects on health and the environment; and
WHEREAS: The city of Berkeley, California, has amended the hazardous materials section of its Municipal Code in order to monitor those impacts; now therefore be it
ORDERED: That the City Manager be and hereby requested to examine the nanotechnology ordinance for Berkeley, California, and recommend an appropriate ordinance for Cambridge.
The document of the Cambridge Civic Council Meeting is available here. It has also been in the reported in the news:
Cambridge, Mass. is considering becoming the second city in the country to regulate nanotechnology-- the science of building devices at the molecular scale -- a month after Berkeley, Calif. became the first.
(Note: Boston Business Journal's definition of nanotech above appears to depict molecular manufacturing, this could be misleading with regards to the regulation of nanoparticles)

I have one more question. Supposed the City found that certain nanoparticle have a "med" or "high" risk, what will it attempt to do?

(Many Thanks to: Nabil A Al Hadithy, Secretary CEAC)

 

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Julie Estelle on Playboy, child pornography?

Wednesday, January 31, 2007

Lawyer Ari Juliano (popularly known by collegues as "Ajo") blogged about Julie Estelle's appearance in Playboy Magazine. In case you don't know the person, its that young artist playing in the movie Alexandria or something.

Anyway, If she's truly 17 when the photos were made, Ajo is correct in pointing out that she is not old enough to enter into agreement with a third party. Thus, she'd had to be represented by her parents as under the civil code, the minimum age required by someone to obtain full legal capacity is 21, unless the person is married. Even under the child protection law, she is still technically a 'child', as the age for adulthood there is 18 . The question is, would her photo session with playboy amount to child pornography?

Child pornography is a term not known to the child protection law. However, the law does punish anyone who economically or sexually exploited children for their or other people's benefit in Article 88. I think we should note that Article 88 used the disjunctive "or". Secondly, the word "benefit" in the article contains a burden of proof. Thirdly, the word "exploitation" is also something that needs to be proven.

If a parent ask a child to leave his school and work 12 hours a day to generate income, it is clear that it amounts to "economic exploitation". But if the child work only twice in a month for 3 hours and she agreed to it, then its not an exploitation, its "nurturing the talent".

And how are we supposed to define "sexual exploitation"? Well it depends. If my client the child's parents, then I can say: "Hey, this is a criminal provision, it has to be interpreted strictly. Sexual exploitation only occurs when the child commits intercourse or other sexually related activities with another person". On the other hand, if I am the prossecutor, I can say: "Those who buys Playboy are buying it for sexual reason (uh oh?). That is why it is called an adult magazine, because it has a 'lust' orientation. Anyone who asks a child to pose in that magazine is therefore responsible for inducing a sex oriented activity."

Oh well...

 

Guide to doing business in Indonesia

Tuesday, January 30, 2007

When I browsed around d Net a few days ago, I found a good paper in Lex Mundi titled "Guide to Doing Business in Indonesia". The 54-page paper was prepared by ABNR Lawfirm in 2005. I did only a skimming and it seems to me that the content is quite comprehensive. It discusses a wide range of legal aspects related to business in Indonesia, from types of visas to Foreign Direct Investment, environmental, employment, also land related rights and Intellectual Property Rights. In its appendix, it listed some samples of BKPM forms.

As to my knowledge, there was a slight change on the labor law due to Constitutional Court's decision. The BKPM forms and the negative list of investment could also be amended. You can check the latest form at BKPM's website or you can search it in the search box in the right panel of this blog.

As an overall, the Guide is quite useful to get general information on doing business in Indonesia.

To download the Guide, simply click here. It's free.

 

Death of a notorious lawyer to be investigated

The Jakarta Post gave a shocking news this morning:

Ciputat Police chief First Insp. Prayitno found possible rope marks on Frank's neck, but officers at the scene said there was no place to tie a rope. Prayitno said the body had been taken to city-run Fatmawati Hospital, South Jakarta, for an autopsy. As a legal practitioner, Supit established Makarim&Taira S corporate financial law firm in 1980.

Mr. Frank Taira was known as one of Indonesia's top lawyer. Our condolences to the families and relatives.

 

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How to cut red tapes

Sunday, January 28, 2007

If you go to Sunda region (that is to say, west java), you will find sour -- but very tasty -- food called tape. You should try the food, but, let's skip the culinary talks for now ;)

Sarapan ekonomi suggest an easy way to boost indonesia's economy: cut the red tape. Here's what he said:
But, let me offer an "easy" shortcut to Indonesia's prosperity: Cut red tapes, leave entrepreneurs alone, and let them create jobs. As I have always said, all we need to do are shredding some paper forms and closing some offices. Nothing would be easier than that.

Can't agree more. I wrote in my 2005 article on how the red tape looks like in Indonesian legal system:
Indonesia's legal system recognizes the hierarchy of rules ranging from the Constitution, laws and Government Regulations in lieu of Law (Perpu), followed by Implementing Regulations that consist of Government Regulations (Peraturan Pemerintah), Presidential Regulations (Perpres) and Regional Bylaws (Perda). There have been around 8,000 such regulations in recent years.

That figure still excludes bilateral treaties to which Indonesia is a party and sectoral regulations. A note must be taken that in the wake of decentralization, local administrations will enact regulations more often. If there are 400 regencies and municipalities in Indonesia and each of them creates 10 regional regulations per year, then there might be an additional 4,000 or so regulations per year.

Some people think that more regulations means more justice. I think its misleading. More regulations means more tax, more desks, more envelopes to be prepared, more red tape. I am personally in favor of de-regulation. OK, in some cases it's no-no. But, if we really need regulation, why don't we just install an automated system? Computers can do it all and computers don't need retirement fees...

 

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Will blogs transform the nature of legal services?

Friday, January 26, 2007

It has been an honour that political analyst Fatih Syuhud reviewed this blog in his "blog of the week" feature. Here's a quote:
Some non-law students are just reluctant to read anything to do with law because the writer uses too rigid a language which is hardly understood by non-law student...

The stark substantial differences between modern people and "primitive" ones is not about the physical appearances, it's about how thirsty we are to acquire new knowledge and information, which are ups for grabs in front us. Al Afghani's blog content is one of those information that we should read regularly and joyfully to quench our thirst of knowledge just in case you are one of those modern and civilized persons.

Not only that the law is difficult to understand for lay people, it is also expensive and not reliable. Am I right or am I wrong? In theory, the law is created for the people, and not the other way around. Is there any way to bring the law closer to the people?

It is possible. Ever heard of "Law 2.0"? Click it if you are curious. Blog is a part of Law 2.0. Blogs can make legal services faster, better and cheaper. How?
  1. Collaboration. My researches and blog posts may be useful for the legal people. They can cite, improve and edit my article to create a legal memo. No need to do another research. There is no use reeinventing the wheel
  2. Better scrutinies. If you write a legal analysis alone and put in your desktop, only you and probably your partner knows if you made any mistakes. But if you publish it online, maybe other lawyers or me would be able to comment should you make errors, vice versa
  3. Niche-creation. If there are too many law blogs (US has so many legal blogs), bloggers will start creating niche content to attract visitors. This is positive for legal specialization
  4. Blogs will give opportunities for small and boutique lawfirms or even solo career lawyers. In light of regional autonomy, this is very good
There are barriers to these possibilities: (i) slow internet connection, (ii) reluctancy to write, (iii) fear in giving away opinions, (iv) materialism. Point iv is really something outdated, if you read Time's 2006 man of the year.