Jordan adheres to WTO rules, in particular the TRIPS agreement, but the regulatory environment is still facing criticism.
Prior to developments in the late 1990s, Jordan was regularly placed on the USTR 301 Priority Watch List for copyright infringement and breaking patent laws. Since its accession to the WTO, Jordan has demonstrated its commitment to WTO rules, in particular the TRIPS agreement. This is exemplified by the recent improvements to, and enforcement of, intellectual property protection.
Jordan’s regulatory environment has been criticised in the past, mainly by international manufacturers, for regulatory discrimination in favour of domestic companies, as the approval time seemed to be much shorter for local products and there have been reports of these products ‘queue-jumping’ others.
However, Jordan has since made significant inroads into improving and enforcing IP protection. This has led to Jordanian authorities now being criticised by domestic producers, over the blocked registration of 39 pharmaceuticals, as they infringe copyright laws.
While this change of attitude towards IP laws has produced criticism from and problems for some domestic producers, the overall effect of an improved IP business environment has arguably been beneficial. In particular, the pharmaceutical industry as a whole is expected to benefit from increased foreign direct investment and more international companies considering joint ventures or subcontracting.
Further reading - A detailed review of the Jordanian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Jordan (published April 2010)
Showing posts with label TRIPS. Show all posts
Showing posts with label TRIPS. Show all posts
Friday, 7 May 2010
Thursday, 28 January 2010
Bangladesh - Could the disorganisation in the OTC and distribution sectors seriously affect the Bangladeshi pharmaceutical market as a whole?
There have been a number of worrying signs for the Bangladeshi pharmaceutical market in the last year.
Reportedly, unscrupulous drug sellers sell almost 90% of stocked drugs without prescription. Bangladesh is an extremely poor country, and many of the population cannot afford to see health professionals when they fall ill. There has therefore been a long tradition of self-medication in the country, which, for a country where many citizens are uneducated, leads to the misuse of drugs; a study by the University of Dhaka found that 83.4% of people have bought drugs or medicines in life without a formal prescription of a physician. Unlike in other markets, the Bangladeshi pharmaceutical distribution network tends to be more retail-orientated and the bulk of distribution is done by the companies themselves. However, drug stores at Dhaka's major wholesale market closed their shutters in November 2009 in protest against the arrest of their fellow traders in the port city of Chittagong. An anarchic situation is prevailing in the marketing and sales of medicines in the Bangladesh; thousands of illegal and unlicensed drug stores exist in the country. On top of this, the scandal involving Rid Pharmaceuticals, which led to the deaths of 24 children, highlighted the shortcomings of the regulatory agency, the DDA.
Due to the sheer size of the population, Bangladesh cannot simply be dismissed. The country has a large generics market, and companies such as Square and Beximco are beginning to have success overseas. However, despite the country possessing huge manufacturing capabilities which supply 96% of domestic need, the complete lack of R&D in domestic companies could cause the market to stagnate, especially if companies have not evolved by the time the TRIPS agreement comes into effect. Having said that, multinationals should view Bangladesh as a possible manufacturing base. Bangladesh also appears politically stable after decades of instability and coups, and the economy is growing by over 6% per annum.
Further reading - An in-depth analysis of the Bangladeshi pharmaceutical market is available from Espicom: The Pharmaceutical Market: Bangladesh (published January 2010)
Reportedly, unscrupulous drug sellers sell almost 90% of stocked drugs without prescription. Bangladesh is an extremely poor country, and many of the population cannot afford to see health professionals when they fall ill. There has therefore been a long tradition of self-medication in the country, which, for a country where many citizens are uneducated, leads to the misuse of drugs; a study by the University of Dhaka found that 83.4% of people have bought drugs or medicines in life without a formal prescription of a physician. Unlike in other markets, the Bangladeshi pharmaceutical distribution network tends to be more retail-orientated and the bulk of distribution is done by the companies themselves. However, drug stores at Dhaka's major wholesale market closed their shutters in November 2009 in protest against the arrest of their fellow traders in the port city of Chittagong. An anarchic situation is prevailing in the marketing and sales of medicines in the Bangladesh; thousands of illegal and unlicensed drug stores exist in the country. On top of this, the scandal involving Rid Pharmaceuticals, which led to the deaths of 24 children, highlighted the shortcomings of the regulatory agency, the DDA.
Due to the sheer size of the population, Bangladesh cannot simply be dismissed. The country has a large generics market, and companies such as Square and Beximco are beginning to have success overseas. However, despite the country possessing huge manufacturing capabilities which supply 96% of domestic need, the complete lack of R&D in domestic companies could cause the market to stagnate, especially if companies have not evolved by the time the TRIPS agreement comes into effect. Having said that, multinationals should view Bangladesh as a possible manufacturing base. Bangladesh also appears politically stable after decades of instability and coups, and the economy is growing by over 6% per annum.
Further reading - An in-depth analysis of the Bangladeshi pharmaceutical market is available from Espicom: The Pharmaceutical Market: Bangladesh (published January 2010)
Friday, 14 August 2009
India - Authorities to Reimburse Costs of Drug Shipments which Avoid EU
The Indian government is to reimburse drugmakers for the extra costs incurred when shipping their products to developing nations and avoiding the European Union (EU), where a number of shipments have been confiscated recently, it was announced in August 2009.
More than 20 shipments of generic drugs, manufactured by companies such as Aurobindo, Cipla and Dr Reddy’s, have been seized in the past 16 months, according to government officials. Shipments were seized in the Netherlands, France, Germany and the UK while on their way to Asia, Africa and Latin America, after claims that they were breaching EU intellectual property (IP) laws.
India is issuing a formal complaint to the World Trade Organisation’s dispute settlement body, claiming that the EU has misused customs regulations to unlawfully seize the medicines. Particularly highlighted is EC Regulation 1383/2003, which is designed to protect the IP rights of EU member states and allows the seizure of shipments infringing IP regulations or if they are believed to be counterfeit.
A group of non-governmental organisations have called for the World Health Organisation (WHO) and the WTO to investigate the issue. They also pointed out that, under WTO rules, IP rights apply at the shipment’s departure and destination locations only, and so represent a violation of TRIPS Agreements.
Meanwhile, the EU, according to Oxfam, is pushing for the rules to be extended globally through free trade agreements and the Anti-Counterfeiting Trade Agreement (ACTA), which is currently being drawn up by 12 nations and the EU. This is due to start its sixth round of negotiations in South Korea in November 2009.
Further reading - An in-depth analysis of the Indian pharmaceutical market, including some background information on intellectual property and TRIPS regulations, is available from Espicom: The Pharmaceutical Market: India (published June 2009)
More than 20 shipments of generic drugs, manufactured by companies such as Aurobindo, Cipla and Dr Reddy’s, have been seized in the past 16 months, according to government officials. Shipments were seized in the Netherlands, France, Germany and the UK while on their way to Asia, Africa and Latin America, after claims that they were breaching EU intellectual property (IP) laws.
India is issuing a formal complaint to the World Trade Organisation’s dispute settlement body, claiming that the EU has misused customs regulations to unlawfully seize the medicines. Particularly highlighted is EC Regulation 1383/2003, which is designed to protect the IP rights of EU member states and allows the seizure of shipments infringing IP regulations or if they are believed to be counterfeit.
A group of non-governmental organisations have called for the World Health Organisation (WHO) and the WTO to investigate the issue. They also pointed out that, under WTO rules, IP rights apply at the shipment’s departure and destination locations only, and so represent a violation of TRIPS Agreements.
Meanwhile, the EU, according to Oxfam, is pushing for the rules to be extended globally through free trade agreements and the Anti-Counterfeiting Trade Agreement (ACTA), which is currently being drawn up by 12 nations and the EU. This is due to start its sixth round of negotiations in South Korea in November 2009.
Further reading - An in-depth analysis of the Indian pharmaceutical market, including some background information on intellectual property and TRIPS regulations, is available from Espicom: The Pharmaceutical Market: India (published June 2009)
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