●Regulatory Regime
Pharmaceuticals used in Cambodia are approved by the Cambodian Ministry of Health (MoH) though theDepartment of Drugs, Food and Cosmetics. The unit is in charge of organising and implementing thenational policy on medicines, sales and controls for the use of pharmaceutical products and medical instruments.The Ministry’s National Laboratory for Drug Quality Control (NLDQC) is the body in charge of testingmedicines and giving approvals. Exports must also be licensed by the Cambodian authorities, with the process being criticised for taking up to four months. The government is reportedly working on thetransformation of the NLDQC into an autonomous body.
カンボジアで使用される医薬品は、カンボジアの健康省(MoH)が、医薬品、食品および化粧品局の元で承認を行う。同局は、薬品に関する国内方針の調整と実施を行うと同時に、その販売、医薬品と医療機器の使用に関する規制をしている。健康省が管理する、国内医薬品品質管理研究所(NLDQC)は、医薬品の試験と認証を行う機関である。輸出品はカンボジア当局によるライセンスが必要であり、ライセンス認証までに最長4ヶ月が必要となる場合があるあため、これが批判の対象となっている。政府が、国内医薬品品質管理研究所を、独立した団体として機能させるために努力し続けていることが報告されている。
Currently, however, corruption, a lack of adequate financing and cumbersome bureaucracy are providingobstacles to the registration of medicines, especially those of foreign origin, while also giving rise tocounterfeiting.
Consequently, multinational companies are viewed as being wary of committing to theCambodian pharmaceutical market, both in terms of direct presence and imports of novel drugs.
●Intellectual Property Environment
Cambodia does not feature in the Pharmaceutical Research and Manufacturers of America (PhRMA)’sSpecial 301 Submission for 2009 nor for 2010. However, this is due to its strategic (un)importance to USdrugmakers, rather than the fact that it does not suffer from IP deficiencies.
その結果として、多国籍企業は直接のプレゼンスや次世代型創薬の輸入の両方に関して、カンボジアの医薬品市場への傾倒に慎重になっている。
●知的財産環境
カンボジアは米国研究製薬工業協会（PhRMA)の２００９年ないし２０１０年の特別301提案を取り入れていない。しかしながら、これは、IP不足に困っていないという事実よりも、アメリカ製薬メーカーへの戦略的(不）重要性のためである。
結果的に、多国籍企業は、カンボジアの製薬市場に直接参入するため、および新しい医薬品を持ち込むために力を入れることに懸念を示している。
●知的所有権保護の環境
カンボジアはPharmaceutical Research and Manufacturers of America（PhRMA :米国研究製薬工業協会）の2009年度および2010年度のSpecial 301 Submission（特別301報告）には記載されていない。ただし、これは知的所有権の保護が無くても、それが侵害されないというのではなく、米国製薬会社にとって、カンボジアが戦略的に重要であるかどうかということを反映している。
Cambodia is a member of the WTO, having been accepted in 2004 following nine years of negotiation.
Therefore, the country is theoretically compliant with WTO’s Trade-Related Aspects of IntellectualProperty Rights (TRIPS) agreement, which has been designed to protect patents, trademarks and undisclosed business information.
The country had aimed to pass TRIPS-compliant legislation by the startof 2007, but the deadline does not appear to have been met.In late 2009, the government confirmed its intention to align the legislation with the TRIPS agreement, aswell as – more significantly – the controversial 2001 Doha Declaration.
ゆえに、特許、商標および公開されている商情報を守ることを目的としている世界貿易機関の知的財産権の貿易関連の側面に関する協定（TRIPS）を理論上遵守せねばならない。
カンボジアはTRIPSを遵守した法律を2007年からの施行を目指して通過させようとしていたが、その締め切りに間に合うことはできなかった。カンボジア政府はTRIPS協定と整合性の取れた法律を整備する意思を確認した。また、より重要なことであるが、議論の的になりがちな2001年のドーハ宣言についても同様な意思を確認した。
The latter would allow domesticproduction of essential medicines that would otherwise be patent protected. Taking this route wouldpotentially bring short-term benefits to Cambodia (given its limited manufacturing expertise), but alsodiscourage involvement by multinationals.
Nevertheless, Cambodia’s Commerce Ministry was reported to be drafting a Law on CompulsoryLicensing for Public Health, which was to be considered by the Council of Ministers and implementedbefore the end of 2009. The main reasoning behind the move, which does not appear to have been approved, had been that foreign generic drugmakers would set up factories to supply the local market ofsome 14mn people.
それにも関わらず、カンボジアの商業省は公衆衛生に関する資格認証義務に関する法を作成中であると伝えられている。これは、閣僚評議会で討議され、2009年末までに施行される予定である。この動きの主な理由は、今のところ認められていないようだが、外国資本の製薬会社に製造設備を設立させて、約1400万人の人口に医薬品を提供させるという見込みのようである。
On a positive note, the country became a member of the ASEAN, which works towards regionaleconomic harmonisation and lowering of tariff rates for trade with other member states, in 1999.
The membership, achieved just years after the country went through a major economic crisis, has contributedto the overall economic recovery and the further industrialisation of most of the country’s sectors.
●Pricing And Reimbursement
By value, funding for around 70% of medicines sold on the market is sourced out-of-pocket in theabsence of a national health insurance network and adequate funding of medical facilities.
NGOs areactive in providing minimum care, medical and pharmaceutical, to the most in need, but many patients remain unable to gain access to required services and medicines.
Most public hospitals must still apply to the MoH to fund their medical equipment and pharmaceuticalproducts, although some have gained autonomy in recent years (see Healthcare System). Medicines(mostly just those regarded as basic and ‘essential’) are currently supplied to hospitals every six months,which creates major problems for the establishments’ day-to-day operations and fails to addressemergency situations. Additionally, bureaucracy is opaque and purchasing decisions are often lacking intransparency.
Private hospitals and retail pharmacies are therefore responsible for meeting the majority ofthe market demand, with prices determined by market forces rather than government decrees.
In April 2009, according to The Phnom Penh Post, the price of medicines for resistant malarial strains inCambodia was to fall from US$6-10 to US$0.20-0.50, thanks to the anti-malarial fund launched by Roll-Back Malaria. Prices will be lowered through subsidies and agreements with pharmaceutical companies.The Roll-Back Malaria organisation is a public-private partnership (PPP) that includes UNICEF, theWorld Bank, private donors and other national governments.
