On March 16th the Right to Health Committee presented the second draft of the unified Health Code bill. It contains a new article on biological drugs and a new chapter entirely dedicated to the fight against cancer. At the same time, in terms of drugs, it modifies the access conditions, the lists, the generic definitions, reference definitions and their labeling. The bill will be observed and ruled in the committee and then voted in the floor of the Assembly. This will occur in the upcoming weeks.
The Draft Health Organic Code was presented, for the first time, on March 23rd, 2016. The president of the Right to Health Committee, William Garzón (Alianza Pais – Ruling Party) was its main promoter. After the bill was ruled by the Health Committee it was discussed in it’s first debate in the Assembly floor. Later, it was turned for the second time to the Committee which worked on a second draft. Among the main changes are:
- Biological drugs. Article 298 will regulate its use. Those who do not have the authorization of the National Health Authority (ASN) can not be used, and must meet the requirements required by it.
- Guarantee of Access and Rational Use. The ASN will guarantee equitable, effective and timely access to drugs. At the same time, it will ensure rational use by stimulating mechanisms that allow citizens to receive them in doses and periods appropriate to their clinical needs, considering criteria of cost effectiveness for them and the community.
- Generic Drugs are defined for the first time. They will be those pharmaceutical products that constitute a pharmaceutical or alternative pharmaceutical equivalent to the reference medicine. The ASN will promote the production, import, commercialization and sale of them. The establishments that are in the Public Health Network, or private institutions with public financing, will be obliged to buy medicines of this type, provided that they respond to the best interest of the State.
- Reference Drugs. They will be those that have been registered for the first time before the competent agency in regards to control and sanitary surveillance of use and human consumption; and that have proven their quality, safety and efficacy.
- Labeling. Adds mandatory data to those labeled in medicines marketed in Ecuador. In addition to the health registration number, expiration date, retail price, the International Common Denomination must be added clearly and visibly in such a way that it prevails over the brand of medication and the manufacturer. Without it, it can not be marketed in the country.
- Drug Listings. It will be prepared by the Commission of Medicines and Health Technologies of the National Health System. They should be updated at least every two years in search of better cost-benefit, quality and effectiveness criteria. The institutions of the Comprehensive Public Health Network and health service providers that receive financing from the State are obliged to buy the medicines from the national list of essential medicines. Only exceptional authorizations will allow this to be overcome.
- Fight against cancer. Inserts an entire chapter in the prevention and fight against cancer echoing the claims of the “National Network of Agreement against Cancer”:
- In response to the claims, it is established that people with oncological diseases will be included in the Disability Law to avoid labor or accessibility discrimination.
- The ASN will create, regulate, articulate and conduct the specialized network of comprehensive oncological care in Ecuador. It will be responsible for improving the health of patients, deploying timely diagnosis and prevention measures.
The presentation of the unified bill is the first step for its final path in the National Assembly. Based on it, the debate will begin in the Health Committee. It will issue a report that will enable the second debate in the National Assembly. There, a positive result in the vote will turn the bill into law.