The full report is here. Excerpts discussing concerns regarding pharmaceuticals in middle income countries follow.
Egypt
In 2009, the Ministry of Health and Population issued Decree 373 to replace Egypt’s “cost-plus” system of pharmaceutical pricing with a new system that would set the price of brand-name drugs in Egypt 10 percent lower than the lowest international sale price for the drug. The decree also sets the price ceiling for generic drugs at 60 percent to 70 percent of the amount of the brand-name drug, which is higher than the average sale price for generics in Egypt. The decree, however, was prevented from taking effect by an April 2010 ruling by the Administrative Court. The Ministry of Health and Population has appealed and the Supreme Administrative Court is expected to rule on the case soon.
Czech Republic
U.S. pharmaceutical companies have expressed concern about the Czech Republic‘s system for determining pricing and reimbursement levels for pharmaceutical products. The United States has encouraged the Czech government to review its current pricing and reimbursement system to ensure that it does not unfairly limit the access of innovative pharmaceutical products to the Czech market.
Hungary
Pharmaceutical manufacturers have expressed concern about Hungary‘s volume and pricing restrictions, high sector-specific taxes, and delays in reimbursement approvals. The United States has encouraged the Hungarian government to review its pricing and reimbursement system to ensure that affected stakeholders have adequate opportunities to engage with relevant authorities to address their concerns.
Poland
U.S. pharmaceutical companies have expressed concerns about the lack of adequate transparency and of meaningful engagement in the development and implementation of government cost containment measures affecting reimbursement and pricing policies in Poland. The United States has encouraged the government of Poland to ensure that policies affecting the pharmaceutical industry are developed and implemented in a transparent manner and that industry is given opportunities to address their concerns and to ensure the continuing development of their already significant investment in the Polish market.
Tiawan
However, the U.S. pharmaceutical industry continues to express concern that measures related to pricing and reimbursement inadequately take into account the value of innovative products and adversely affect patients‘ ability to access new pharmaceutical products. For instance, in Taiwan, hospitals derive significant revenue from the difference between the prices they negotiate with drug companies and the higher amounts that the Bureau of National Health Insurance (BNHI) reimburses for the same drugs. To close the gap, BNHI uses the Price Volume Survey (PVS) to collect “market” price data from hospitals and drug makers for calculating new, lower drug reimbursements. The hospitals, in turn, re-negotiate contracts with drug companies after each PVS, driving prices down further while perpetuating the reimbursement gap at lower price levels. The process threatens to drive foreign pharmaceutical firms out of Taiwan’s market as their profit margins dwindle through each successive PVS cycle. … The United States encourages Taiwan to continue to consult with relevant stakeholders in implementing policies that will facilitate the private sector‘s development of innovative products and improve patients‘ access to such products.
Thailand
In the pharmaceutical sector, the Government Pharmaceutical Organization (GPO) is not subject to registration requirements faced by the private sector. The Council of State is currently reviewing a proposed law, however, that would eliminate GPO’s exemption from these requirements. GPO also is exempt from complying with the requirements of the safety monitoring period (SMP) when producing and marketing generic formulations of drugs marketed in foreign countries. Other manufacturers are subject to a mandatory two-to-four-year SMP for all new chemical entities registered and approved for marketing in Thailand. This and other Thai government requirements limiting government hospitals‘ procurement and dispensing of drugs not on the national list of essential drugs significantly constrain the availability of many imported products.
Turkey
The pharmaceutical industry reports that its sales have been severely affected by government price controls and an awkward, burdensome reimbursement system. In 2008, Turkey implemented changes in its reimbursement scheme that increased the cost borne by pharmaceutical manufacturers. In September 2009, faced with a growing health care budget deficit, the Turkish government decreed additional mandatory discounts totaling over $2.3 billion. A large majority of the burden of these discounts fall on foreign manufacturers of pharmaceuticals. In December 2009, the government and pharmaceutical industry agreed on a compromise pricing deal that will require U.S. firms to provide extra discounts of approximately $800 million per year.
Vietnam
Pharmaceutical companies have raised concerns about possible discriminatory treatment against foreign firms across a range of product registration requirements for imported pharmaceuticals. The United States will continue to work closely with the Ministry of Health and other relevant agencies to seek improvements in the transparency of the pharmaceutical regulatory process.