The Global Legal Monitor is an online publication from the Law Library of Congress covering legal news and developments worldwide. It is updated frequently and draws on information from official national legal publications, and reliable press sources. You can find previous news by searching the Global Legal Monitor.

For questions about articles or copies of materials in the Law Library’s collections, contact us at glm@loc.gov.

Current News

Resources

Search Legal News Archives
Find legal news by topic, country, keyword, date, or author

Get Global Legal Monitor on PDF
Monthly issues from May 2006 to July 2008 are available.

Global Legal Monitor RSS
Get the Global Legal Monitor delivered to your inbox, free.

European Union: New Regulation on Clinical Trials

To link to this article, copy this persistent link:
http://www.loc.gov/lawweb/servlet/lloc_news?disp3_l205403932_text

(Apr 15, 2014)

On April 14, 2014, a new regulation on the authorization of clinical trials was adopted at the European Union level by the Council of the EU. The European Parliament approved the regulation in December 2013. (Press Release, Council of the European Union, Council Adopts New Rules on Clinical Trials, CONSILIUM [Council of the European Union official website] (Apr. 14, 2014).) The new regulation replaces two existing Directives, 2001/20/EC and 2005/28/EC, on establishing rules for good clinical practice and on requirements for authorization of the manufacturing or importation of medicinal products for human use, respectively. (Clinical Trials, European Commission website (last visited Apr. 16, 2014).)

The old clinical trials regime has been subject to criticism by patients, researchers, and the pharmaceutical industry because of its extensive regulatory requirements, high cost, and lack of harmonization of rules for multinational clinical trials. All of these factors contributed to a decline in the number of trials conducted in the EU. It is estimated that during the period 2007-2011, the number of applications for clinical trials decreased by 25%. (Press Release, Memo/14/254, European Commission, Q&A: New Rules for Clinical Trials Conducted in the EU, EUROPA (Apr. 2, 2014).)

The new regulation establishes the uniform application of common standards governing clinical trials across the EU and aims to attract more researchers to conduct clinical trials in the EU by simplifying and expediting the authorization procedure. Under the prior legal regime, an authorization was necessary in each Member State where the clinical trial was to be conducted. (Council Adopts New Rules on Clinical Trials, supra.)

The major highlights of the regulation are:

· Clinical trials must be authorized within 60 days. If no decision is made within the deadline, authorization is considered as having been given through tacit approval.

· Decisions on applications for large-scale modifications of clinical trials must be taken within 49 days. If the deadline passes without a decision having been made, authorization is deemed to have been granted.

· One single application will be sufficient for conducting clinical trials in several EU Member States. (Id.)

A Clinical Trials Register, maintained by the European Medicines Agency, has been in operation online since 2011 and allows public access to information on clinical trials for medicines authorized in the 28 EU Member States and in Iceland, Liechtenstein, and Norway. (Clinical Trials, EU Clinical Trials Register website (last visited Apr. 16, 2014).)

Author: Theresa Papademetriou More by this author
Topic: Health More on this topic
 International organizations More on this topic
 Medical research More on this topic
Jurisdiction: European Union More about this jurisdiction

Back to Top

Indonesia: Plan to Revise Foreign Investment Rules

To link to this article, copy this persistent link:
http://www.loc.gov/lawweb/servlet/lloc_news?disp3_l205403931_text

(Apr 15, 2014)

Indonesia's Coordinating Minister for Economic Affairs, Hatta Rajasa, announced on April 11, 2014, that in the near future Indonesia plans to revise its current "negative investment list," which has been used to protect domestic industries considered to be "sensitive." No indication was given as to which industries would be removed from the list. (Rieka Rahadiana, Indonesia to Issue Revised Foreign Investment Rules Next Week, JAKARTA GLOBE (Apr. 11, 2014).)

The plan to reform the rules follows a slowing down of foreign investment in Indonesia. In addition, the country's negative foreign currency accounts had led to a 20% reduction in the value of Indonesia's currency against the U.S. dollar. (Id.)

The negative investment list, formed under Indonesian government decrees of 2007 and 2010, indicates sectors of the economy that are "either wholly or partially closed to private foreign and/or domestic investment … ." (Negative Investment List, Indonesia Investment Coordinating Board (IICB) website (last visited Apr. 14, 2014); The Presidential Regulation of the Republic of Indonesia on the Criteria and Establishment of Closed Business Line and Open Business with Conditions in Respect of Capital Investment, No. 76/2007 (July 3, 2007), IICB website; The Presidential Regulation of the Republic of Indonesia on List of Business Fields Closed to Investment and Business Fields Open, with Conditions, to Investment, No. 36/2010
(May 25, 2010), IICB website.)

The announcement of the planned revision comes after the December 2013 statement that an increase in foreign investment would be permitted in power plants, advertising, and pharmaceuticals. At that time, proposals to let foreign investors participate in air and sea ports were turned down. (Rahadiana, supra.)

Author: Constance Johnson More by this author
Topic: Foreign investments More on this topic
Jurisdiction: Indonesia More about this jurisdiction

Back to Top

Egypt: Council of Ministers Issues Decree Classifying Muslim Brotherhood as Terrorist Organization

To link to this article, copy this persistent link:
http://www.loc.gov/lawweb/servlet/lloc_news?disp3_l205403930_text

(Apr 15, 2014)

On April 8, 2014, the Council of Ministers of Egypt issued Decree No. 579-2014, implementing a court decision issued on December 24, 2013, classifying the Muslim Brotherhood as a terrorist organization. (Council of Ministers Decree No.579-2014 [in Arabic], 14 AL JARIDAH AL RASSMAYAH (Duplicate (d)) (Apr. 9, 2014).) The Muslim Brotherhood organization is a religious and political group founded in 1928 on the belief that Islam is not simply a religion, but a way of life. It promotes insulation from secularism and strictly abiding by the rules of the Quran. (Muslim Brotherhood, ENCYCLOPAEDIA BRITANNICA ONLINE (last visited Apr. 16, 2014); Bryony Jones & Susannah Cullinane, What Is the Muslim Brotherhood?, CNN (July 3, 2013).)

The Decree provides that any individual who promotes orally and in writing the membership or activities of the Muslim Brotherhood organization will be punished according to the penalties established under the Anti-Terrorism Law No. 97 of1992. It also calls for the punishment of any one who finances or joins that organization. (Decree No. 579-2014; Anti-Terrorism Law, Law 97 of 1992, 29 AL JARIDAH AL RASSMAYAH 3 (July 18, 1992.)

In addition, the Decree requires the Egyptian government to notify all the Arab countries that joined the Anti-Terrorism Convention of 1998 of the December 2013 court decision and of any Council of Ministers' decrees implementing that decision. (Id.; Decision of the President of the Republic No. 279 of1998 on Joining the Arab Convention to Combat Terrorism, 18 AL JARIDAH AL RASSMAYAH 1312 (May 6, 1999).) Finally, the Decree orders law enforcement personnel, including members of police forces and the army, to protect government property from any future attacks that might be carried out by individuals affiliated with the Muslim Brotherhood organization. (Decree No. 579-2014.)

Author: George Sadek More by this author
Topic: Associations More on this topic
 Terrorism More on this topic
Jurisdiction: Egypt More about this jurisdiction

Back to Top

Brazil: New Environmental Policy

To link to this article, copy this persistent link:
http://www.loc.gov/lawweb/servlet/lloc_news?disp3_l205403929_text

(Apr 15, 2014)

On April 14, 2014, the Government of Portugal published Law No. 19, which defines the basis for the country's environmental policy pursuant to the terms of articles 9 and 66 of the Constitution. (Lei No. 19/2014 de 14 de Abril, DIÁRIO DA REPÚBLICA No. 73, 1ª Série, 2400, LEGIX; Constituição da República Portuguesa [2005], ASSEMBLEIA DA REPÚBLICA.PT.)

According to Law No. 19, the new environmental policy is designed to realize environmental rights through the promotion of sustainable development. That development is to be supported by the proper management of the environment, in particular ecosystems and natural resources, which must contribute to the development of a low-carbon society and a "green economy," with rational and efficient use of natural resources. The economy must ensure the welfare and the gradual improvement of the quality of life of the citizens. (Law No. 19, art. 2(1).)

Law No 19 declares that government action on environmental issues is based on the following principles:

• sustainable development, which requires the satisfaction of present needs without compromising those of future generations and which requires the preservation of natural resources and cultural heritage; planning for the long-term production capacity of ecosystems; balanced and rational planning of the territory for the purpose of overcoming regional disparities; promotion of territorial cohesion and sustainable production and consumption of energy; and preservation of the biodiversity, biological and climate balance, and geological stability that harmonizes human life and the environment (id. art. 3(a));

• intra- and inter-generational responsibility, which requires the use and exploitation of natural and human resources in a rational and balanced way, in order to ensure their preservation for present and future generations (id. art. 3(b));

• adoption of proactive measures in order to remedy or alleviate, at the source, adverse impacts on the environment, whether of natural or human origin, both in face of immediate dangers or in contemplation of future risks. If there is uncertainty about the level of risk, the burden of proof lies with the party claiming the absence of hazard or risk (id. art. 3(c));

• adoption of a policy that requires the person responsible for any pollution to bear the costs associated with the polluting activity and that introduces internal measures designed to prevent and control the threats to and aggression against the environment (id. art. 3(d));

• for the purpose of rational use of resources, assumption by the users of public services of the costs of use of those resources, as well as of a fair proportion of the costs associated with making the resources available (id. art. 3(e));

• accountability of all persons who, directly or indirectly, intentionally or negligently, cause damage or pose a threat to the environment. It is the duty of the state to apply penalties, including the possibility of requiring payment for restitution under the law (id. art. 3(f)); and

• assignment of responsibility to whoever causes damage to the environment for restoration of the environment to its original condition as it stood prior to the harmful event (id. art. 3(g)).

Constitutional Provisions

The relevant parts of the Portuguese Constitution mentioned in the article state:

Article 9 (Fundamental tasks of the state)

The fundamental tasks of the state are:

a) To guarantee national independence and create the political, economic, social and cultural conditions that promote it; …
d) To promote the people's well-being and quality of life and real equality between the Portuguese, as well as the effective implementation of economic, social, cultural and environmental rights by means of the transformation and modernization of economic and social structures;
e) To protect and enhance the Portuguese people's cultural heritage, defend nature and the environment, preserve natural resources and ensure correct town and country planning; …
g) To promote the harmonious development of the whole of Portuguese territory, with particular regard to the ultra-peripheral nature of the Azores and Madeira archipelagos; … .

Article 66 (Environment and quality of life)

1. Everyone has the right to a healthy and ecologically balanced human living environment and the duty to defend it.
2. In order to ensure the right to the environment within an overall framework of sustainable development, the state, acting via appropriate bodies and with the involvement and participation of citizens, is charged with:
a) Preventing and controlling pollution and its effects and the harmful forms of erosion;
b) Conducting and promoting town and country planning …;
c) Creating and developing natural and recreational reserves and parks and classifying and protecting landscapes and places …;
d) Promoting the rational use of natural resources …;
e) In cooperation with local authorities, promoting the environmental quality of rural settlements and urban life …;
f) Promoting the integration of environmental objectives into the various policies…;
g) Promoting environmental education and respect for environmental values and assets;
h) Ensuring that the fiscal policy renders development compatible with the protection of the environment and the quality of life. (Constitution of the Portuguese Republic, Seventh Revision, 2005, ASSEMBLEIA DA REPÚBLICA.PT [English portal].)

Author: Eduardo Soares More by this author
Topic: Environmental protection More on this topic
Jurisdiction: Brazil More about this jurisdiction

Back to Top

Kyrgyz Republic (Kyrgyzstan): Increased Punishment for Involvement in Prostitution Proposed

To link to this article, copy this persistent link:
http://www.loc.gov/lawweb/servlet/lloc_news?disp3_l205403928_text

(Apr 15, 2014)

On March 27, 2014, the legislature of Kyrgyzstan initiated amendments to the country's Criminal Code that provide for increased punishments for crimes associated with involving other persons in prostitution. (Punishment for Involvement in Prostitution Will Be Increased in Kyrgyzstan [in Russian], LENTA.RU (Mar. 27, 2014).)

If the amendments are passed, the crime of "engaging others in prostitution" will be punishable by a fine in an amount equal to US$6,000-$10,000 or imprisonment for a term of from three to five years. Those who commit this crime within an organized group will be imprisoned for up to eight years, with seizure of their property. (Id.; text of the legislation in Russian can be downloaded from the Jogorku Kenesh [the parliament of the Kyrgyz Republic] website (last visited Apr.7, 2014).)

At present, this crime is punishable by imprisonment for up to three years. The Kyrgyz draft legislation defines "engagement of others in prostitution" as involvement of minors and adults in the provision of sexual services and maintaining facilities where such services are offered. (Criminal Code of the Kyrgyz Republic [official text, in Russian], Law No. 68 of Oct. 1, 1997 (as amended by Law No. 10 of Mar. 1, 2012), arts. 124, 157, Jogorku Kenesh website.)

Prostitution is not a crime under Kyrgyz law. In 2012, several efforts were made to introduce in the legal system criminal and administrative liability for offering sexual services because, according to the Ministry of Internal Affairs (police), which was behind these attempts, prostitution in Kyrgyzstan is connected with organized crime and is a leading source of drug use and alcoholism. However, these suggestions were not supported by legislators. (Punishment for Involvement in Prostitution Will Be Increased in Kyrgyzstan, supra.) According to local police, there are about 3,000 working prostitutes in the Kyrgyz capital city of Bishkek, and this business generates about US$10 million monthly. (Punishment for Involvement in Prostitution Will Be Increased in Kyrgyzstan, supra; Press Release, Jogorku Kenesh, Public Discussion on Proposed Amendments to the Criminal Code Will Start on February 19 [in Russian] (Feb. 19, 2014).)

Author: Peter Roudik More by this author
Topic: Organized crime and gangs More on this topic
 Sex offenses More on this topic
 Women's rights More on this topic
Jurisdiction: Kyrgyz Republic (Kyrgyzstan) More about this jurisdiction

Back to Top