Localization
Corral Rosales / Ecuador
A brief overview of the situation regarding localization in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.
1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?
Any new productive investments, including investments made on the pharmaceutical sector, that are initiated until August 2022, may benefit from tax exemptions. If the investment is located in Quito or Guayaquil, the entity will be exempt from paying corporate income tax for 8 years from the fiscal year it starts generating income. If the investment is located outside of Quito or Guayaquil, the entity will be exempt from paying corporate income tax for 12 years. Existing entities may also benefit from this exemption if new investments are made, on a proportional basis.
In addition, new investments may benefit from exemption of customs tariffs and foreign exchange tax and on the import of capital assets and raw materials.
2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?
The tax benefits applicable for new investments described above were established on August 21, 2018 and were extended for two additional years on August 19, 2020.
3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
Localization has no effect.
4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
Localization has no effect.
5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
Localization has no effect.
6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
Localization has no effect.
7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?
Localization has no effect.
8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?
No, only those set out at point 1.
9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?
The last legal reform affecting the relevant localization policies was in August 2020. There is currently no discussion as to new localization policies, and we do not consider that there would be any changes to these in the near future.
Recap Table
| Country ECUADOR | Research | Clinical Trials | API Content | Fill and Finish | Packaging |
| Require/Benefit | B | B | B | B | B |
| Requirement | |||||
| Benefits | Tx | Tx | Tx | Tx | Tx |
Line 1
0 – if neutral
R – if a requirement B – if provides benefit
Line 2 and 3 Fill in (according to answer in Line 1)
MA – Market Access
P – Pricing
R – Reimbursement
T – Tenders
Tx – Taxes and import tarifs
